The Recall Desk

Archive

September 2022 recalls

527 recalls were announced in September 2022.

What the numbers show

Critical
21
Severe
145
High
306
Moderate
53
Low
2

Of the 527 recalls this month scored against our rubric, 4% are Critical, 28% are Severe.

401–500 of 527

  • SevereFDA (Devices)·Z-1521-2022·2022-09-07

    NIM EMG Endotracheal Tubes recalled for risk of airway obstruction

    Medtronic Xomed is recalling NIM EMG Endotracheal Tubes due to reports of airway obstruction during use. The recall affects 23,820 units distributed worldwide.

    Product
    NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229307J b) REF 8229308J c) REF 8229306J
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1584-2022·2022-09-07

    Wegmans Lemon Dill Finishing Butter Recalled for Potential Listeria Contamination

    Wegmans Lemon Dill Finishing Butter is being recalled due to potential Listeria monocytogenes contamination from the frozen dill ingredient. The recall affects 1,137 cases distributed to Wegmans stores in eight states and Washington, DC.

    Product
    Wegmans Lemon Dill Finishing Butter, NET WT 3.5 OZ (99g), black plastic cup with a sealed lidding film under the lid. Best By and Lot # printed with blue ink by the label around the cup. UPC 0 77890 44324 8. Distributed By: Wegman Food Markets Inc. Rochester, NY 14603 Keep Refri
    Category
    Food
    Distribution
    8 states
  • SevereFDA (Food)·F-1669-2022·2022-09-07

    Kate Farms Nutrition Shake recalled nationwide for pathogenic contamination

    Kate Farms Nutrition Shake is recalled nationwide due to findings of Cronobacter sakazakii and Clostridium botulinum. The recall covers multiple lot codes with best-by dates spanning September 2022 to January 2023.

    Product
    kate farms Nutrition Shake, Vanilla. 11 fl oz (325 mL) UPC 8 11112-03058 4. 12 count case UPC 00811112030591. Shake Well. After opening, refrigerate and use within 4 days. Made for Kate Farms, Inc., 101 Innovation Place, Santa Barbara, CA 93708
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1671-2022·2022-09-07

    Kate Farms Peptide 1.5 Nutrition Formula Recalled for Bacterial Contamination

    Kate Farms Peptide 1.5 Cal/mL nutrition formula is being recalled nationwide due to findings and potential for Cronobacter sakazakii and Clostridium botulinum.

    Product
    kate farms Peptide 1.5 Cal/mL, Plain, Sole-Source Nutrition Formula. 325 mL (11 fl oz) UPC 8 51823-00646 1. 12 count case UPC 00851823006379. Shake Well. A ready-to-use oral and tube feeding formula with enzymatically hydrolyzed organic pea protein. Made for Kate Farms, In
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1622-2022·2022-09-07

    Nationwide recall of Oatly Oat-Milk Barista Edition for bacterial contamination

    Oatly Oat-Milk Barista Edition is recalled nationwide for potential Cronobacter sakazakii and Clostridium botulinum contamination. Approximately 53.8 million units are affected, spanning multiple lot codes from August 2022 through April 2023.

    Product
    The Original OATLY Oat-Milk Barista Edition. 32 fl oz (1qt) (946mL). UPC 1 90646-63005 8. Packaged in 12 count case UPC 10190646630055. Once opened store in refrigerator and consume within 7 days. Enjoy chilled. Distributed by: Oatly, Inc., 220 E 42nd St. Ste 409A
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1632-2022·2022-09-07

    Sysco Imperial Med Plus Vanilla Nutritional Drink Recalled for Bacterial Contamination

    Lyons Magnus recalls Sysco Imperial Med Plus Vanilla Nutritional Drink nationwide for Cronobacter sakazakii and Clostridium botulinum contamination. The recall affects 53,818,025 units.

    Product
    Sysco Imperial Med Plus 2.0 Vanilla Nutritional Drink. High Calorie, High Protein. Mildly Thick Nectar Consistency. 32 FL OZ (1 QT) 946mL UPC 0 74865-92730 7. Reorder # 0108910. 12 count case UPC 10074865927304. Refrigerate prior to serving. Shake well. Refrigerat
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1670-2022·2022-09-07

    Kate Farms Nutritional Formula Recalled for Cronobacter and Botulism Risk

    Kate Farms Standard 1.4 Cal/mL nutrition formula in 325 mL bottles is recalled nationwide due to potential Cronobacter sakazakii and Clostridium botulinum. Affected lot code 8031 has best-by date November 4, 2022.

    Product
    kate farms Standard 1.4 Cal/mL, Plain, Sole-Source Nutrition Formula. 325 mL (11 fl oz) UPC 8 11112-03001 0. 12 count case UPC 00811112030027. Shake Well. A ready-to-use oral and tube feeding formula. Made for Kate Farms, Inc., 101 Innovation Place, Santa Barbara, CA 9370
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1641-2022·2022-09-07

    Stumptown Cold Brew Coffee Recalled Due to Bacterial Contamination

    Lyons Magnus, Inc. is recalling Stumptown Cold Brew Coffee with Oat Milk Chocolate nationwide due to findings of Cronobacter sakazakii and Clostridium botulinum. The FDA-classified Class I recall affects over 53 million units.

    Product
    Stumptown Cold Brew Coffee with Oat Milk Chocolate. Plant Based. Low Sugar. Made with Oatly! 11 Fl Oz. 325 ML. UPC 8 55186-00688 5. Sold in 12-count case UPC 10855186006882. Manufactured for Stumptown Coffee Roasters, 100 SE Salmon St. Portland, OR 97214
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1607-2022·2022-09-07

    Cold Coffee Recalled Nationwide for Bacterial Contamination Risk

    Intelligentsia Cold Coffee in 10.9 oz containers is recalled nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination. Consumers should not consume the product.

    Product
    Intelligentsia, Cold Coffee. Net 10.9 fl oz (325 mL) Tetra Pak container UPC 8 00222-00096 9. Shake Best enjoyed cold. Refrigerate after opening. Produced for: Intelligentsia Coffee, Inc., Aloha, Chicago, IL 60612.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1663-2022·2022-09-07

    Abbott PediaSure Harvest 1.0 Cal tube-feeding formula recalled nationwide

    Abbott PediaSure Harvest 1.0 Cal tube-feeding formula is recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Approximately 53,818,025 units with specific lot codes spanning September 2022 through April 2023 are affected.

    Product
    Abbott PediaSure Harvest 1.0 Cal, For Tube Feeding. Complete nutrition blend. 8 fl oz (237mL). UPC 0 70074-67963 1. 24 count case UPC 00070074679624. Shake very well. Store unopened at room temperature. Once opened, reclose, refrigerate, and use within 24 hours. Manufact
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1626-2022·2022-09-07

    Protein Shake Recalled Nationwide for Potential Bacterial Contamination

    Lyons Magnus is recalling MRE Cookies & Cream Protein Shake nationwide due to potential findings of Cronobacter sakazakii and Clostridium botulinum. The FDA has classified this as a Class I recall.

    Product
    MRE Cookies & Cream Protein Shake. Whole Food Protein High protein shake. 11 FL OZ (325mL) Tetra Pak. UPC 8 10044-57389 3. 4-count case UPC 810044573961. Refrigerate after Opening. Distributed by: Redcon1, LLC, 701 Park of Commerce Blvd, Boca Raton, FL 33487
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1623-2022·2022-09-07

    Premier Protein Shakes Recalled for Potential Bacterial Contamination

    Lyons Magnus is recalling Premier Protein Chocolate High Protein Shakes nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination. Consumers should not consume affected products and should return them.

    Product
    Premier Protein Chocolate High protein shake. 11 FL OZ (325mL). Packaged in the following configurations: 1. Carton UPC 6 43843-71447 7 packed in 12 count case UPC 643843714200. 2. Carton UPC 6 43843-71534 4 packed in 18 count case UPC 643843718581. Shake W
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1643-2022·2022-09-07

    Stumptown Cold Brew Coffee Recalled Nationwide for Bacterial Contamination

    Lyons Magnus Inc. is recalling Stumptown Cold Brew Coffee with Cream & Sugar nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum bacteria.

    Product
    Stumptown Cold Brew Coffee with Cream & Sugar Chocolate. 11 Fl Oz. 325 ML. UPC 8 55186-00686 1. Sold in 12-count case UPC 108551860006861. Manufactured for Stumptown Coffee Roasters, 100 SE Salmon St. Portland, OR 97214
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1606-2022·2022-09-07

    Aloha Organic Protein Drink recalled nationwide for potential bacterial contamination

    Lyons Magnus is recalling 53.8 million units of Aloha Organic Protein Drink iced coffee variety nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.

    Product
    Aloha Organic Protein Drink, Iced Coffee Plant-based protein. Net 11 FL OZ (330 mL) Tetra Pak container UPC 8 42096-11238 6. Sold as 4 count package wrap with UPC 842096122385. Shake Well. Best Chilled. Manufactured for: Aloha, Littleton, CO 80127
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1610-2022·2022-09-07

    Lyons Ready Care Thickened Dairy Drink recalled for potential pathogen contamination

    Lyons Magnus is recalling Ready Care Thickened Dairy Drink nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Multiple lot codes are affected; consumers should not consume affected product.

    Product
    Lyons Ready Care Thickened Dairy Drink. Mildly Thick Nectar Consistency. Pasteurized - Grade A Made with 2% Milk Fat Milk, Vitamins A & D Packaged in the following sized Tetra Pak containers: 1. 8 FL OZ (237 mL) UPC 0 45796-10043 5. Item 10043. 24 count case UPC 1004579
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1649-2022·2022-09-07

    Cafe Grumpy Cold Brew Coffee Recalled for Potential Bacterial Contamination

    Lyons Magnus is recalling Cafe Grumpy Ready to Drink Cold Brew Coffee nationwide due to findings of and potential for Cronobacter sakazakii and Clostridium botulinum. Affected lots have best-by dates of 08/27/2022 or 08/28/2022.

    Product
    Cafe Grumpy Ready to Drink Cold Brew Coffee 11 fl oz. UPC 7 58524-05908 9. Sold in 4-count case UPC 00758524059003. Refrigerate after opening. Shake before opening. Cafe Grumpy Beverage Company, 199 DiamondSt., Brooklyn, NY 11222
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1605-2022·2022-09-07

    Aloha Organic Protein Drink Recalled for Bacterial Contamination

    Aloha Organic Protein Drink in Vanilla flavor is being recalled nationwide due to findings of Cronobacter sakazakii and Clostridium botulinum. Affected products include specific lot codes with best-by dates from 2022 and 2023.

    Product
    Aloha Organic Protein Drink, Vanilla Plant-based protein. Net 11 FL OZ (330 mL) Tetra Pak container UPC 8 42096-11234 8. Sold in 4 count Package wrap with UPC 842096122347. Shake Well. Best Chilled. Manufactured for: Aloha, Littleton, CO 80127
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1657-2022·2022-09-07

    Sated Complete Keto Meal Shake Chocolate recalled for potential bacterial contamination

    Lyons Magnus, Inc. recalls Sated Complete Keto Meal Shake Chocolate Flavor due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. More than 53 million units distributed nationwide.

    Product
    Sated Complete Keto Meal Shake Chocolate Flavor. 11 fl oz (325ml) UPC 8 57227-00721 9. 12 Count Case UPC 00857227007219. Distributed by LongRun LLC, Belmont, MA 02478. Important: Must be refrigerated after opening to maintain safety.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1628-2022·2022-09-07

    MRE Salted Caramel Protein Shake Recalled for Cronobacter and Botulinum Risk

    Lyons Magnus recalls MRE Salted Caramel Protein Shake nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination. Consumers should not consume affected products.

    Product
    MRE Salted Caramel Protein Shake. Whole Food Protein High protein shake. 11 FL OZ (325mL) Tetra Pak. UPC 8 10044-57392 3. 4-count case UPC 810044573930. Refrigerate after Opening. Distributed by: Redcon1, LLC, 701 Park of Commerce Blvd, Boca Raton, FL 33487
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1650-2022·2022-09-07

    Tone It Up Plant-Based Protein Shakes Recalled for Bacterial Pathogen Risk

    Lyons Magnus is recalling 53.8 million units of Tone It Up Plant-Based Protein Shake nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination. Affected lot codes are 0321 and 1321.

    Product
    Tone It Up Plant-Based Protein Shake Chocolate. 11 fl oz (325mL). UPC 8 10745-03194 4. Sold in 4-count wrap UPC 810745031869. Shake Well. Serve Cold. Refrigerate after opening and use within 48 hours. Distributed by Tone It Up, Manhattan Beach, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1620-2022·2022-09-07

    Plant Protein Drink Recalled for Potential Bacterial Contamination

    Lyons Magnus recalled pirq Plant Protein Super Foods drink due to potential Cronobacter sakazakii and Clostridium botulinum contamination. Consumers should not consume the product.

    Product
    pirq Plant Protein Super Foods, Golden Vanilla Drink, Almonds, Curcumin, Maca. 11 FL OZ (325ML). UPC 8 57690-00804 1. Packaged in the following configurations: 1. 12 count case UPC 857690008157. 2. 4 count wrap UPC 857690008256. Chill it, Shake it. Do not Fr
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1639-2022·2022-09-07

    Chocolate Syrup Recalled Nationwide for Potential Bacterial Contamination

    Lyons Magnus is recalling chocolate syrup (MIDRWB36XX, Item 10137) distributed nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination.

    Product
    Chocolate Syrup, MIDRWB36XX. Item 10137 Ingredients: water, cocoa (processed with alkali), cane sugar. Net: 235 gal (889.6L) Lyons Magnus Fresno, CA 93702
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1662-2022·2022-09-07

    Optimum Nutrition whey protein recalled for potential botulinum and Cronobacter contamination

    Optimum Nutrition Gold Standard 100% Whey Chocolate is recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Over 53 million units affected.

    Product
    Optimum Nutrition Gold Standard 100% Whey Chocolate 11 fl oz (325mL). UPC 7 48927-06409 4. Shake well. Best when served chilled. Manufactured for Optimum Nutrition, Inc., 3500 Lacey Road, Suite 1200, Downers Grove, IL 60515
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1664-2022·2022-09-07

    Abbott PediaSure Harvest infant nutrition recalled for bacterial contamination

    Abbott PediaSure Harvest 1.0 Cal formula is being recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum bacteria.

    Product
    Abbott PediaSure Harvest 1.0 Cal, For Tube Feeding. Complete nutrition blend. 8 fl oz (237mL). UPC 0 70074-67963 1. 24 count case UPC 00070074679624. Shake very well. Store unopened at room temperature. Once opened, reclose, refrigerate, and use within 24 hours. Manufact
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1625-2022·2022-09-07

    Premier Protein Cafe Latte Shakes Recalled for Pathogenic Bacteria

    Premier Nutrition is recalling Premier Protein Cafe Latte shakes distributed nationwide due to contamination findings with Cronobacter sakazakii and Clostridium botulinum bacteria. Over 53 million units are affected.

    Product
    Premier Protein Cafe Latte High protein shake. 11 FL OZ (325mL). Packaged in the following configurations: 1. Carton UPC 6 43843-71668 6 packed in 4 count wrap UPC 643843716679. 2. Carton UPC 6 43843-71665 5 packed in 18 count case UPC 643843718567. Shake Well
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1601-2022·2022-09-07

    Glucerna Creamy Strawberry Shake recalled for potential bacterial contamination

    Glucerna original Creamy Strawberry Shake is being recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected products should not be consumed.

    Product
    Glucerna original Creamy Strawberry Shake, 8 FL OZ (237 mL). Delicious Snack or Small Meal Replacement. UPC 0 70074-68567 0. Sold as 24 count case, Case UPC 0070074685663. Shake Well. Serve cold. Refrigerate after opening. Manufactured for: Abbott Nutrition, Abbott Lab
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1655-2022·2022-09-07

    Organic Valley 1% lowfat milk recalled nationwide for pathogenic contamination

    Lyons Magnus is recalling Organic Valley 1% lowfat milk nationwide due to Cronobacter sakazakii and Clostridium botulinum contamination. Consumers should not consume the affected product.

    Product
    Organic Valley Organic 1% Milkfat Lowfat Milk. 8 fl oz UPC 0 93966-00837 1. 12 Count wrap UPC 00093966008524. Chill and Shake before serving. Refrigerate after opening. Distributed by CROPP Cooperative La Farge, WI 54639.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1656-2022·2022-09-07

    Organic Valley Organic Whole Milk recalled for potential Cronobacter and botulinum contamination

    Lyons Magnus is recalling approximately 53.8 million units of Organic Valley Organic Whole Milk nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum.

    Product
    Organic Valley Organic Whole Milk. 8 fl oz UPC 0 93966-00818 0. 12 Count Case UPC 00093966008531.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1645-2022·2022-09-07

    Lyons Barista Style Soy Non-Dairy Beverage recalled for potential bacterial contamination

    Lyons Magnus is recalling Lyons Barista Style Soy Non-Dairy Beverage nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination affecting over 53 million units.

    Product
    Lyons Barista Style Soy Non-Dairy Beverage. 32 fl oz. (1QT) 946mL UPC 0 45796-10181 4. Sold in 12-count case UPC 10045796101811. Lyons Magnus, Fresno, CA 93702.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1629-2022·2022-09-07

    MRE Vanilla Protein Shake Recalled for Potential Bacterial Contamination

    Lyons Magnus is recalling MRE Vanilla Protein Shake nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum bacteria.

    Product
    MRE Vanilla Protein Shake. Whole Food Protein High protein shake. 11 FL OZ (325mL) Tetra Pak. UPC 8 10044-57390 9. 4-count case UPC 810044573954. Refrigerate after Opening. Distributed by: Redcon1, LLC, 701 Park of Commerce Blvd, Boca Raton, FL 33487
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1642-2022·2022-09-07

    Stumptown Cold Brew Coffee with Oat Milk Recalled for Bacterial Contamination Risk

    Lyons Magnus is recalling Stumptown Cold Brew Coffee with Oat Milk nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume the affected product.

    Product
    Stumptown Cold Brew Coffee with Oat Milk Horchata. Plant Based. Made with Oatly! 11 Fl Oz. 325 ML. UPC 8 55186-00689 2. Sold in 12-count case UPC 108551860006892. Manufactured for Stumptown Coffee Roasters, 100 SE Salmon St. Portland, OR 97214
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1672-2022·2022-09-07

    Kate Farms Pediatric Peptide Formula Recalled for Bacterial Contamination

    Lyons Magnus is recalling kate farms Pediatric Peptide formula nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination. The recall affects 53.8 million units of this ready-to-use pediatric nutrition formula.

    Product
    kate farms Pediatric Peptide 1.5 Cal/mL, Vanilla, Sole-Source Nutrition Formula. 250 mL (8.45 fl oz) UPC 8 51823-00687 4. 12 count case UPC 00851823006201. Shake Well. A ready-to-use oral and tube feeding formula with enzymatically hydrolyzed organic pea protein. Made for
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1653-2022·2022-09-07

    Uproot Peamilk Chocolate Recalled for Cronobacter and Botulism Risk

    Lyons Magnus is recalling Uproot Peamilk Chocolate nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The recall affects 53,818,025 units.

    Product
    Uproot Peamilk Chocolate 8 fl oz. (240mL) UPC 8 60002-91544 9. Serve chilled, refrigerate after opening and use within 7 days. Manufactured for Uproot, Inc., New York, NY 10005. Sold in 18-count case UPC 10860002915446. .
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1614-2022·2022-09-07

    Lyons Ready Care 2.0 Vanilla Drink Recalled Nationwide for Bacterial Contamination

    Lyons Magnus is recalling Lyons Ready Care 2.0 Vanilla nutritional drink nationwide due to findings and potential for Cronobacter sakazakii and Clostridium botulinum contamination. Consumers should not consume affected products.

    Product
    Lyons Ready Care 2.0 Vanilla High Calorie, High Protein, Nutritional Drink. 32 FL OZ (1 QT) 946mL UPC 0 45796-10091 6 Item 10091. 12 count case UPC 10045796100913. Refrigerate after opening. Lyons Magnus, Fresno, CA 93702.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1520-2022·2022-09-07

    NIM EMG Endotracheal Tubes recalled for risk of airway obstruction

    Medtronic Xomed recalls 1.1 million NIM EMG Endotracheal Tubes worldwide due to reports of airway obstruction. FDA classified this as Class I.

    Product
    NIM EMG Endotracheal Tube, Part Numbers: a) REF 8229308 b) REF 8229307 c) REF 8229306
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1659-2022·2022-09-07

    Rejuvenate Muscle Health+ chocolate drink recalled nationwide for bacterial pathogens

    Lyons Magnus, Inc. is recalling Rejuvenate Muscle Health+ Chocolate, a nationwide distributed ready-to-drink beverage, due to findings and potential presence of Cronobacter sakazakii and Clostridium botulinum.

    Product
    Rejuvenate Muscle Health+ Chocolate 11 fl oz. (330mL). UPC 6 29046-50401 5. Serve Cold, shake well. Manufactured exclusively for Element Nutrition, Ltd., 1887 Whitney Mesa Dr. #6020, Henderson, NV 89014. 4-count wrap UPC 629046544011.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1603-2022·2022-09-07

    Aloha Organic Protein Drink Recalled Due to Pathogen Contamination Risk

    Lyons Magnus recalls Aloha Organic Protein Drink nationally due to potential presence of Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume affected products.

    Product
    Aloha Organic Protein Drink, Chocolate Sea Salt, Plant-based protein. Net 11 FL OZ (330 mL) Tetra Pak container UPC 8 42096-11235 5. Sold in 4 count package wrap with UPC 842095122354. Shake Well. Best Chilled. Manufactured for: Aloha, Littleton, CO 80127
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1608-2022·2022-09-07

    Intelligentsia Oat Latte recalled nationwide due to potential bacterial contamination

    Intelligentsia Oat Latte is recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected products have lot codes 7112 (01/04/2023) and 8112 (01/05/2023).

    Product
    Intelligentsia, Oat Latte. Cold Coffee + Oat Milk. Net 10.9 fl oz (325 mL) Tetra Pak container UPC 8 00222-00097 6. Refrigerate after opening. Produced for: Intelligentsia Coffee, Inc., Aloha, Chicago, IL 60612.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1633-2022·2022-09-07

    Sysco Imperial Med Plus Nutritional Drink Recalled for Bacterial Contamination

    Sysco Imperial Med Plus NSA 1.7 Vanilla Nutritional Drink has been recalled nationwide due to findings and potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume the product.

    Product
    Sysco Imperial Med Plus NSA 1.7 Vanilla Nutritional Drink. High Calorie, High Protein. Mildly Thick Nectar Consistency. 32 FL OZ (1 QT) 946mL UPC 7 34730-31074 9. Reorder # 0794018. 12 count case UPC 10734730310746. Refrigerate prior to serving. Shake well. Refr
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1612-2022·2022-09-07

    Lyons Ready Care Thickened Dairy Drink Recalled for Bacterial Contamination

    Lyons Magnus is recalling Lyons Ready Care Thickened Dairy Drink nationwide due to findings and potential for Cronobacter sakazakii and Clostridium botulinum contamination.

    Product
    Lyons Ready Care Thickened Dairy Drink. Moderately Thick Honey Consistency. Pasteurized - Grade A Made with 2% Milk Fat Milk, Vitamins A & D Packaged in the following sized Tetra Pak containers: 1. 8 FL OZ (237 mL) UPC 0 45796-10044 2. Item 10044. 24 count case UPC 1004
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1600-2022·2022-09-07

    Abbott Glucerna Rich Chocolate Shake recalled nationwide for pathogenic bacteria

    Lyons Magnus is recalling Glucerna original Rich Chocolate Shake nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The recall affects approximately 53.8 million units distributed across the U.S.

    Product
    Glucerna original Rich Chocolate Shake, 8 FL OZ (237 mL). Delicious Snack or Small Meal Replacement. UPC 0 70074-68565 6. Sold in 24 count case, UPC Case 0070074685649. Shake Well. Serve cold. Refrigerate after opening. Manufactured for: Abbott Nutrition, Abbott Labora
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1618-2022·2022-09-07

    Plant Protein Drink Recalled Nationwide for Cronobacter and Botulism Contamination Risk

    Lyons Magnus recalls its pirq Plant Protein Super Foods drink nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should discard or return the product.

    Product
    pirq Plant Protein Super Foods, Decadent Chocolate Drink, Almonds, Curcumin, Maca. 11 FL OZ (325ML). UPC 8 57690-00806 5. Packaged in the following configurations: 1. 12 count case UPC 857690008164. 2. 4 count wrap UPC 857690008317. Chill it, Shake it. Do not
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1613-2022·2022-09-07

    Lyons Ready Care 2.0 Nutritional Drink Recalled for Bacterial Contamination

    Lyons Magnus is recalling Lyons Ready Care 2.0 Butter Pecan nutritional drink due to findings of bacterial contamination. The product may contain Cronobacter sakazakii or Clostridium botulinum, which can cause serious illness.

    Product
    Lyons Ready Care 2.0 Butter Pecan High Calorie, High Protein, Nutritional Drink. 32 FL OZ (1 QT) 946mL UPC 0 45796-10049 7 Item 10049. 12 count case UPC 10045796100494. Refrigerate after opening. Lyons Magnus, Fresno, CA 93702.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1619-2022·2022-09-07

    Pirq Caramel Coffee Plant Protein Drink Recalled for Bacterial Contamination

    Pirq Plant Protein Super Foods Caramel Coffee Drink has been recalled nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination affecting 53,818,025 units.

    Product
    pirq Plant Protein Super Foods, Caramel Coffee Drink, Almonds, Curcumin, Maca. 11 FL OZ (325ML). UPC 8 57690-00808 9. Packaged in the following configurations: 1. 12 count case UPC 857690008140. 2. 4 count wrap UPC 857690008263. Chill it, Shake it. Do not Fr
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1652-2022·2022-09-07

    Uproot Oatmilk Organic Oats Recalled for Bacterial Contamination Risk

    Uproot Oatmilk Organic Oats is recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected units have lot code 8502 with best-by date 02/22/2023.

    Product
    Uproot Oatmilk Organic Oats 8 fl oz. (240mL) UPC 8 60002-91543 2. Manufactured for Uproot, Inc., New York, NY 10005. Serve chilled, refrigerate after opening and use within 7 days. Sold in 18-count case UPC 10860002915439 .
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1676-2022·2022-09-07

    Oatly Oat Drink Recalled for Bacterial Contamination Findings

    Oatly Oat Drink Deluxe 330ml is being recalled for findings of Cronobacter sakazakii and Clostridium botulinum. Approximately 53.8 million units nationwide are affected. Consumers should not consume the product.

    Product
    PROUCT WAS NOT DISTRIBUTED IN US. The Original Oatly! Oat Drink Deluxe 330ml. UPC 7 394376 619021 18 count case UPC 27394376619025. Shake well before drinking. Produced in the USA. Oatly AB, Stora Varvsgatan 6a, SE-211 19 Malmo.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1661-2022·2022-09-07

    Whey Protein Drink Recalled Nationwide for Potential Bacterial Contamination

    Optimum Nutrition Gold Standard 100% Whey Vanilla is being recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected product has lot code 2321 with best-by date 08/20/2022.

    Product
    Optimum Nutrition Gold Standard 100% Whey Vanilla 11 fl oz (325mL). UPC 7 48927-06410 0. Shake well. Best when served chilled. Manufactured for Optimum Nutrition, Inc., 3500 Lacey Road, Suite 1200, Downers Grove, IL 60515
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1615-2022·2022-09-07

    Lyons Barista Style Almond Beverage Recalled for Potential Bacterial Contamination

    Lyons Magnus is recalling Lyons Barista Style Almond non-dairy beverage nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume the affected products.

    Product
    Lyons Barista Style Almond, Non-Dairy Beverage. Plant-Based Milk. 32 FL OZ (1 QT) 946mL UPC 0 45796-10165 4. 12 count case UPC 10045796101651. Shake Well before Serving. After opening keep refrigerated and use within 7 days. Lyons Magnus, Fresno, CA 93702.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1665-2022·2022-09-07

    Pediatric Nutrition Formula Recalled for Bacterial Contamination Risk

    Kate Farms Pediatric Peptide formula is being recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum, high-risk pathogens. The formula is designed for children ages 1 to 13.

    Product
    kate farms Pediatric Peptide 1.0 Cal/mL, Vanilla, Sole-Source Nutrition Formula. 250 mL (8.45 fl oz) UPC 8 11112-03052 2. 24 count case UPC 00811112030539. A Oral and Tube Feeding Formula. Specifically designed for children ages 1-13 years old. Not suitable for infants les
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1654-2022·2022-09-07

    Organic Valley Chocolate Milk recalled for pathogen contamination

    Lyons Magnus is recalling Organic Valley Organic Chocolate Milk nationwide due to findings of Cronobacter sakazakii and Clostridium botulinum. Consumers should discard affected products or return them to the store.

    Product
    Organic Valley Organic 1% Milkfat Lowfat Chocolate Milk. Garde A Vitamin A&D UHT. 8 fl oz (236mL) UPC 0 93966-00838 8. Chill and Shake before serving. Refrigerate after opening. Distributed by CROPP Cooperative La Farge, WI 54639. 12 Count wrap UPC 00093966008548
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1667-2022·2022-09-07

    Kate Farms Nutrition Shake recalled for potential bacterial contamination

    Kate Farms Nutrition Shake (Coffee, 11 fl oz) is being recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. The recall affects products with lot codes 7331 and 8031.

    Product
    kate farms Nutrition Shake, Coffee. 11 fl oz (325 mL) UPC 8 11112-03062 1. 12 count case UPC 00811112030638. Shake Well. After opening, refrigerate and use within 4 days. Made for Kate Farms, Inc., 101 Innovation Place, Santa Barbara, CA 93708
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1651-2022·2022-09-07

    Plant-Based Protein Shake Vanilla Recalled for Potential Bacterial Contamination

    Tone It Up Plant-Based Protein Shake Vanilla is being recalled nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume the product and should contact the distributor.

    Product
    Tone It Up Plant-Based Protein Shake Vanilla. 11 fl oz. UPC 8 10745-03177 7. Sold in 4-count case UPC 00810745032361. Shake Well. Serve Cold. Refrigerate after opening and use within 48 hours. Distributed by Tone It Up, Manhattan Beach, CA
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1658-2022·2022-09-07

    Protein Drink Recalled for Potential Cronobacter and Botulinum Contamination

    Lyons Magnus recalls Rejuvenate Muscle Health+ Vanilla nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume affected products.

    Product
    Rejuvenate Muscle Health+ Vanilla. 11 fl oz. (330mL) UPC 6 29046-50402 2. Serve Cold, shake well. Manufactured exclusively for Element Nutrition, Ltd., 1887 Whitney Mesa Dr. #6020, Henderson, NV 89014. 4-count Case UPC 629046544028.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1583-2022·2022-09-07

    Lemon Dill Butter Pucks Recalled for Listeria Contamination

    Raw Seafoods Inc. is recalling Lemon Dill Butter Pucks due to Listeria monocytogenes contamination from a recalled dill ingredient. The product was distributed to Ohio and Massachusetts.

    Product
    Lemon Dill Butter Pucks
    Category
    Food
    Distribution
    2 states
  • SevereFDA (Food)·F-1646-2022·2022-09-07

    Lyons Ready Care Vanilla Nutritional Drink Recalled Nationwide

    Lyons Magnus recalls Lyons Ready Care No Sugar Added Vanilla nutritional drink nationwide due to findings and potential for Cronobacter sakazakii and Clostridium botulinum contamination.

    Product
    Lyons Ready Care No Sugar Added 1.7 high Calorie High Protein Nutritional Drink Vanilla. 32 fl oz. (1QT) 946mL. UPC 0 45796-10047 3. Mildy thick Nectar Consistency. Refrigerate prior to serving. Shake well. Sold in 12-count case UPC 10045796100470. Lyons Magnus, Fresno
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1674-2022·2022-09-07

    Oatly Oat Drink Chocolate Recalled Due to Pathogen Contamination Risk

    Lyons Magnus is recalling Oatly Oat Drink Chocolate nationwide due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Consumers should not consume the affected product.

    Product
    The Original Oatly! Oat Drink Chocolate 11 fl oz (330ml). UPC 1 90646-63015 7. 18 count case UPC 20190646630151. Distributed by Oatly Inc., 220 E 42ndSt., Ste. 409A, New York, NY 10017.
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1631-2022·2022-09-07

    Sysco Imperial Dairy Drink Recalled for Cronobacter and Botulism

    Lyons Magnus recalled Sysco Imperial Thickened Dairy Drink nationwide due to potential Cronobacter sakazakii and Clostridium botulinum contamination. The FDA Class I recall affects over 53 million units distributed in 8 oz and 32 oz containers.

    Product
    Sysco Imperial Thickened Dairy Drink. Moderately Thick Honey Consistency. Pasteurized - Made with Grade A 2% Fat Milk, Vitamins A & D. Packaged in the following sized Tetra Pak containers: 1. 8 FL OZ (237 mL) UPC 0 74865-94550 9. Reorder # 0429357. 24 count case UPC
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1666-2022·2022-09-07

    Kate Farms Nutrition Formula Recalled for Cronobacter and Botulinum Risk

    Kate Farms Standard nutrition formula in 325 mL bottles is being recalled due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Approximately 53,818,025 units distributed nationwide.

    Product
    kate farms Standard 1.0 Cal/mL, Vanilla, Sole-Source Nutrition Formula. 325 mL (11 fl oz) UPC 8 51823-00663 8. 12 count case UPC 00851823006683. Shake Well. A ready-to-use oral and tube feeding formula with intact organic pea protein. Made for Kate Farms, Inc., 101 Innovat
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-1640-2022·2022-09-07

    Stumptown Cold Brew Coffee Recalled for Potential Bacterial Contamination

    Stumptown Cold Brew Coffee with Oat Milk Original is being recalled due to potential contamination with Cronobacter sakazakii and Clostridium botulinum. Affected products were distributed nationwide.

    Product
    Stumptown Cold Brew Coffee with Oat Milk Original. Plant Based. Low Sugar. Made with Oatly! 11 Fl Oz. 325 ML. UPC 8 55186-00687 8. Sold in 12-count case UPC 108551860006875. Manufactured for Stumptown Coffee Roasters, 100 SE Salmon St. Portland, OR 97214
    Category
    Food
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1519-2022·2022-09-07

    Medtronic endotracheal tubes recalled for reported airway obstruction risk

    Medtronic Xomed is recalling 81,555 NIM Contact EMG endotracheal tubes worldwide due to reports of airway obstruction during use.

    Product
    NIM CONTACT EMG Endotracheal Tube, Part Numbers: a) REF 8229508 b) REF 8229507 c) REF 8229506
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1660-2022·2022-09-07

    ARCHITECT STAT Troponin-I Reagent Kit Recalled for Insufficient Blocking Agents

    Abbott is recalling one lot of ARCHITECT STAT Troponin-I Reagent Kits due to insufficient heterophilic blocking agents in the conjugate, which may affect test accuracy.

    Product
    ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1647-2022·2022-09-07

    Siemens Artis icono X-Ray Systems Recalled for Potential Hardware Failure

    Siemens has recalled Artis icono X-ray imaging systems due to a potential hardware issue affecting a specific lot of X-ray tubes. If the error detection mechanism fails, the system cannot release X-rays until it is shut down.

    Product
    Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1468-2022·2022-09-07

    Colgate Anticavity Fluoride Toothpaste Recalled for Improper Storage Conditions

    Family Dollar is recalling Colgate OPTIC WHITE CHARCOAL COOL MINT toothpaste (Net Weight 4.2 oz., UPC 0 35000 97872 1) distributed to stores in 11 states due to improper temperature storage during manufacturing.

    Product
    Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net Wt. 4.2 OZ. UPC 0 35000 97872 1. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1465-2022·2022-09-07

    Colgate OPTIC WHITE PRO Series Toothpaste Recalled for Improper Storage

    Family Dollar Stores is recalling 1,120 packages of Colgate OPTIC WHITE PRO SERIES toothpaste due to improper temperature storage conditions that deviate from cGMP standards.

    Product
    Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ. (59 g) UPC 0 35000 99658 9. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1685-2022·2022-09-07

    Sucrose solution vials recalled nationwide for contamination and leaking

    Clinical Innovations is recalling Sweetums 24% sucrose solution vials due to reports of leaking containers and contamination with black liquid and particulates. The product is used in hospital settings including neonatal intensive care units.

    Product
    Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface. Product is only used in the hospital setting
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1672-2022·2022-09-07

    Medical device software error affects toric IOL surgical planning accuracy

    A software defect in the Pentacam AXL Wave eye imaging device's IOL calculator may inaccurately reflect alignment axis and incision position for toric lens surgeries. This affects 21 systems distributed across the U.S.

    Product
    Pentacam AXL Wave REF 70020. Used to image the anterior segment of the eye.
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Food)·F-1682-2022·2022-09-07

    Sweetums Sucrose Solution Recalled for Contamination and Leaking Cups

    Clinical Innovations is recalling Sweetums 24% Sucrose Solution used in NICU settings due to leaking cups and black particulates in the solution. The recall affects 1,773 boxes distributed nationwide.

    Product
    Sweetums 24% Sucrose Solution Preservative Free 15 mL cups VPSU15037288. Each box contains 288 cups. Product is aseptically packaged in 15 mL cups with foil lid. Each cup contains 15 mL of USP purified water, 24% sugar, citric acid (buffer). Cup is latex-free, DEHP-free, BPA-fr
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1648-2022·2022-09-07

    Siemens Dimension Vista CA 15-3 Diagnostic Cartridges Recalled for Measurement Bias

    Siemens Healthcare Diagnostics is recalling Dimension Vista CA 15-3 Flex reagent cartridges because the diagnostic test can produce inaccurate results, reading 26–33% lower than actual values, potentially delaying appropriate patient treatment decisions.

    Product
    Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1645-2022·2022-09-07

    X-Ray Imaging System X-Ray Tube Hardware Defect Worldwide Recall

    Siemens has recalled Artis Q and Artis Q.zen X-ray imaging systems due to a potential X-ray tube hardware defect. In rare cases, if error detection fails, the system will not be able to release X-ray until shut down; 1,389 units are affected globally.

    Product
    Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1581-2022·2022-09-07

    Arborio Rice Recalled for Possible Glass Contamination

    Multiple Arborio rice products are being recalled by Woodland Foods LLC due to possible presence of glass pieces. Consumers should not use the affected products.

    Product
    Woodland Ingredients X06D Arborio Rice, 25 lbs. bag UPC 00687080007374 Woodland Ingredients X16D Italian Arborio Rice, 25 lbs. bag UPC 00687080069143 Sysco International X06D05 Arborio Rice, 25 lbs. bag in box UPC 00074865718257 DGourmet.com X06C Arborio Rice, 10 lbs. bag in box
    Category
    Food
    Distribution
    23 states
  • HighFDA (Devices)·Z-1649-2022·2022-09-07

    Metalogix Self-Drill Half-Pin Surgical Component Recalled for Tip Breakage

    New Standard Device Inc is recalling Metalogix Self-Drill Half-Pins used in external fixation surgery due to reports of tip breakages occurring during surgical procedures.

    Product
    Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metal
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-1644-2022·2022-09-07

    Medtronic EverFlex Peripheral Stents Recalled for Partial Deployment Risk

    Medtronic is recalling EverFlex peripheral stents worldwide due to risk of partial deployment. Updated instructions provide a manual deployment workaround to mitigate potential harms.

    Product
    EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
    Category
    Medical Device
    Distribution
    0 states
  • HighNHTSA·22V670000·2022-09-07

    BMW X7 Third-Row Seat Backrest Springs May Not Lock Properly

    BMW is recalling 2019-2022 X7 models with third-row seats because compression springs may not have been properly installed, causing the seat backrest to potentially fail to lock in a crash.

    Product
    BMW — BMW X7
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1639-2022·2022-09-07

    AggreGuide A-100 Instrument Software Issue Affecting Test Results

    Aggredyne, Inc. is recalling the AggreGuide A-100 Instrument due to a software design defect that causes the device to run assays at 0 RPM, resulting in no blood mixing and inaccurate test results displayed as Low.

    Product
    AggreGuide A-100 Instrument
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1651-2022·2022-09-07

    therascreen FGFR RGQ Kit Recalled for Increased False Positive Results

    Qiagen's therascreen FGFR RGQ RT-PCR Kit is being recalled for increased false positive results in 29 distributed kits. False positives could lead to incorrect lab reports and inappropriate cancer treatment for patients.

    Product
    therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1641-2022·2022-09-07

    TB Diagnostic Test Recalled Due to Storage Temperature Excursion

    Oxford Immunotec recalled 81 T-SPOT.TB diagnostic test kits (Lot TEC4000098) due to storage equipment failure that kept products outside the validated 2-8°C temperature range. The excursion may affect test accuracy.

    Product
    T-SPOT.TB REF TB.300 US
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1666-2022·2022-09-07

    Radiographic imaging system may exceed radiation dose limits in biplane mode

    Canon Medical's Alphenix i imaging systems may deliver radiation dose rates exceeding acceptable limits during biplane fluoroscopic procedures. Sixteen systems nationwide with software versions 8.0, 9.0, or 9.2 and TFP 1200C detector are affected.

    Product
    INFX-8000V. For radiographic and fluoroscopic studies and intervention.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1677-2022·2022-09-07

    ERG! Energy Apricot P'Butter bar recalled for undeclared oats

    ERG Foods is recalling ERG! Energy Apricot P'Butter Fruit and Nut Bars due to undeclared oats. The product may pose a risk to consumers with oat allergies.

    Product
    ERG! Energy Apricot P'Butter Fruit and Nut Bar 2.05oz. individually packaged in clear plastic, UPC Number 863444000421
    Category
    Food
    Distribution
    0 states
  • HighNHTSA·22V671000·2022-09-07

    Nissan Titan vehicles recalled for transmission parking pawl failure risk

    Nissan is recalling 2020-2023 Titan vehicles and certain other models because the transmission parking pawl may fail to engage in park, risking vehicle rollaway and crash.

    Product
    NISSAN — NISSAN TITAN, FRONTIER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1642-2022·2022-09-07

    T-Cell Xtend Test Kit Recalled Due to Improper Storage Temperature

    Oxford Immunotec is recalling 47 units of the T-Cell Xtend REF TTK.610 US test kit due to equipment failure that caused improper storage temperatures outside the validated range. Affected devices may have been compromised.

    Product
    T-Cell Xtend REF TTK.610 US
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-1563-2022·2022-09-07

    Philips Radiography System Firmware Defect Risks Incorrect Radiation Dose

    Philips DigitalDiagnost C50 1.1 radiography systems contain a firmware defect in the Wallstand VS2 board that may cause incorrect radiation dose and anatomic marker misalignment. Eleven affected systems were distributed nationwide.

    Product
    DigitalDiagnost C50 1.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1669-2022·2022-09-07

    Boston Scientific ZOOM LATITUDE Programmer Software Anomaly Recall

    Boston Scientific is recalling ZOOM LATITUDE programmers due to potential software anomalies that could affect communication with implantable defibrillators. No injuries have been reported.

    Product
    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1683-2022·2022-09-07

    Great Value Chopped Walnuts Recalled Due to Pecan Mislabeling

    Great Value Chopped Walnuts pouches containing pecans have been recalled from Walmart distribution centers in North Carolina and Florida. The product was mislabeled, which may affect consumers with nut allergies.

    Product
    Great Value Chopped Walnuts, NET WT 4oz (113g); Ingredients: Walnuts DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716; UPC 0 78742 20134 4
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1667-2022·2022-09-07

    Hip Implant Stem Recalled for Failed Fatigue Testing

    Corin Ltd is recalling a hip implant stem component (Model 588.3800) after some units failed fatigue testing. The affected devices were distributed to New Jersey only.

    Product
    TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip implant component.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1650-2022·2022-09-07

    FGFR cancer diagnostic kit recalled due to increased false positive results

    Qiagen Sciences is recalling therascreen FGFR RT-PCR kits due to increased false positive rates. False results could lead patients to receive unnecessary cancer treatment.

    Product
    therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1670-2022·2022-09-07

    ZOOM LATITUDE Programmer Recalled for Potential Software Communication Anomalies

    Boston Scientific recalled the ZOOM LATITUDE Programmer (Model 2868) for potential software anomalies affecting communication with certain transvenous defibrillators. No injuries have been reported. The recall involves 17,172 units distributed worldwide.

    Product
    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1674-2022·2022-09-07

    Pentacam HR Medical Device Software Error Impacts Surgical Planning

    A software error in the Pentacam HR eye imaging device causes inaccurate IOL calculator output for toric intraocular lens surgical planning. Nineteen systems are affected.

    Product
    Pentacam HR REF 70900. Used to image the anterior segment of the eye.
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Devices)·Z-1652-2022·2022-09-07

    RT-PCR Kit Recalled Due to False Positive Test Results

    Qiagen's FGFR RGQ RT-PCR Kit may produce false positive results, leading to incorrect lab reports. This could expose cancer patients to inappropriate or suboptimal treatment.

    Product
    FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1671-2022·2022-09-07

    Boston Scientific ZOOM LATITUDE Programmer Software Anomaly Recall

    Boston Scientific ZOOM LATITUDE programmer software may have anomalies when communicating with certain Boston Scientific defibrillators, potentially affecting device programming and communication functions.

    Product
    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1681-2022·2022-09-07

    Priyems Mango Pickles recalled for undeclared wheat starch

    Yem Foods LLC is recalling Priyems Mango Pickles (1lb/454g) due to undeclared wheat starch from asafoetida. Consumers with wheat allergies may be at risk.

    Product
    Priyems Mango Pickles 1lb/454g UPC 8 61754 000179, 10 retail units per wholesale case, Refrigerated
    Category
    Food
    Distribution
    15 states
  • HighFDA (Devices)·Z-1673-2022·2022-09-07

    Eye imaging device software defect affects surgical planning calculations

    Pentacam eye imaging devices with certain software versions have a bug that causes inaccurate surgical planning printouts for toric intraocular lens procedures.

    Product
    Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
    Category
    Medical Device
    Distribution
    37 states
  • HighFDA (Food)·F-1684-2022·2022-09-07

    Clinical Innovations Sweetums Sucrose Solution Vials Recalled for Contamination

    Clinical Innovations is recalling Sweetums 24% sucrose solution vials due to complaints of leaking, black liquid, and black particulates in product vials. The recall affects neonatal products distributed nationwide and internationally.

    Product
    Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface. Product is only used in the hospital setti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1638-2022·2022-09-07

    Aesculap ENNOVATE Spine Implants Recalled for Incorrect Screw Inclusion

    Aesculap Implant Systems LLC recalls ENNOVATE SET SCREW spine implants because packages may contain incorrect screws. Six units distributed in Georgia and Texas.

    Product
    Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Drugs)·D-1475-2022·2022-09-07

    Luxury Isopropyl Alcohol Recalled for Undeclared Ethyl Alcohol

    Luxury 70% Isopropyl Alcohol First Aid Antiseptic is recalled because it contains undeclared ethyl alcohol. The product was distributed in Virginia and affects 350,000 bottles across multiple lot numbers.

    Product
    Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965765.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-1705-2022·2022-09-07

    Similac Alimentum infant formula recalled for packaging defect

    Abbott Nutrition is voluntarily recalling Similac Alimentum infant formula in Michigan and Ohio due to a packaging defect. The recall affects 720 bottles with Lot No. 41740RH00.

    Product
    Similac Alimentum packaged in 32 fluid ounce re-closable plastic bottles 6 bottles per case
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-1679-2022·2022-09-07

    Frozen Lentil Soup Recalled for Undeclared Wheat Allergen

    Yem Foods LLC recalls Priyems Sambar Coconut & Onion Spicy Lentil Soup due to undeclared wheat starch found in asafoetida ingredient. The product affects consumers with wheat allergies distributed across multiple states.

    Product
    Priyems Sambar Coconut & Onion Spicy Lentil Soup 800 grams (1.76 lbs) UPC 8 61754 000124, 8 retail units per wholesale case, Frozen
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Food)·F-1678-2022·2022-09-07

    Frozen Lentil Soup Recalled for Undeclared Wheat Allergen

    Yem Foods LLC is recalling Priyems Sambar Spicy Lentil Soup for containing undeclared wheat starch in an ingredient. Consumers with wheat allergies should not consume this product.

    Product
    Priyems Sambar Spicy Lentil Soup 800 grams (1.76 lbs) UPC 8 61754 00010 0, 8 retail units per wholesale case, Frozen
    Category
    Food
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-1646-2022·2022-09-07

    X-ray imaging system hardware defect may prevent operation

    Siemens is recalling certain X-ray imaging systems due to a potential hardware issue with the error detection mechanism. In rare cases, this could prevent X-ray emission until system shutdown.

    Product
    Artis pheno- Model No. 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1471-2022·2022-09-07

    Timolol Maleate eye drops recalled for unknown impurity in stability testing

    Akorn, Inc. is recalling Timolol Maleate Ophthalmic Solution due to identification of an unknown impurity during 12-month stability testing. No illnesses have been reported.

    Product
    Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24
    Category
    Drug
    Distribution
    Distributed nationwide

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