The Recall Desk

Archive

March 2023 recalls

1,013 recalls were announced in March 2023.

What the numbers show

Critical
68
Severe
432
High
400
Moderate
107
Low
6

Of the 1,013 recalls this month scored against our rubric, 7% are Critical, 43% are Severe.

501–600 of 1013

  • SevereFDA (Food)·F-0029-2024·2023-03-22

    Orchard Bistro Tuna Salad Recalled for Potential Listeria Contamination

    Fresh Ideation Food Group is recalling Orchard Bistro Albacore Tuna Salad due to potential Listeria monocytogenes contamination. Products sold January 24–30, 2023 may be affected.

    Product
    Orchard Bistro, Albacore Tuna Salad Wheat, Net . Wt.5.5 Oz. Single Serving, Mylar Wrap, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0221-2024·2023-03-22

    Orchard Bistro Sausage Egg Cheese Croissants Recalled for Potential Listeria Contamination

    Fresh Creative Cuisine is recalling 63 units of Orchard Bistro Sausage Egg & Cheese Croissants due to potential Listeria monocytogenes contamination. Products sold January 24-30, 2023 in 11 states are affected.

    Product
    Orchard Bistro, Sausage Egg & Cheese Croissant, Net . Wt. 6.5 Oz. Single Serving, Mylar Wrap, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0565-2023·2023-03-22

    Sausage Egg & Cheese Croissants recalled for potential Listeria contamination

    Fresh Creative Cuisine is recalling Sausage Egg & Cheese Croissants sold January 24-30, 2023, due to potential Listeria monocytogenes contamination. Affected products were distributed to 11 states.

    Product
    Fresh Creative Cuisine, Sausage Egg & Cheese Croissant, Net . Wt. 6.25 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0239-2024·2023-03-22

    Tuna Salad Kaiser Recall Due to Listeria Contamination Risk

    Fresh Creative Cuisine is recalling Quick & Fresh Tuna Salad Kaiser products sold January 24–30, 2023, due to potential Listeria monocytogenes contamination. The 8 oz packages were distributed across 11 Eastern U.S. states.

    Product
    Quick & Fresh, Tuna Salad Kaiser, Net . Wt. 8 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0213-2024·2023-03-22

    Fresh Creative Cuisine Roast Beef and Provolone Hoagies Recalled for Listeria Risk

    Fresh Creative Cuisine is recalling Roast Beef & Provolone Super Hoagies sold January 24–30, 2023, in 11 states due to potential Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    Fresh Creative Cuisine White Label, Roast Beef & Provolone Super Hoagie, Case of 6, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0284-2024·2023-03-22

    Vanilla Pudding Delight Recalled for Potential Listeria Contamination

    FRESH IDEATION FOOD GROUP is recalling Quick & Fresh Vanilla Pudding Delight (6.5 oz) due to potential Listeria monocytogenes contamination. The affected product was distributed across 11 states from January 24-30, 2023.

    Product
    Quick & Fresh, Vanilla Pudding Delight, Net Wt. 6.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0142-2024·2023-03-22

    In Reach Ham and Provolone Sesame Kaiser Recalled for Listeria Risk

    In Reach Ham & Provolone Sesame Kaiser 6.5 oz sandwiches sold January 24–30, 2023 are recalled for potential Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    In Reach, Ham & Provolone Sesame Kaiser, Net Wt. 6.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0013-2024·2023-03-22

    Bistro to Go Muffins Recalled for Potential Listeria Contamination

    Fresh Ideation Food Group is recalling Bistro to Go Bacon, Egg & Cheddar Muffins (UPC 813141023070) distributed to 11 states due to potential Listeria monocytogenes contamination. The affected product was distributed January 24–30, 2023.

    Product
    Bistro to Go, Bacon, Egg & Cheddar Muffin, Net . Wt. 5.5 Oz. Single Serving, Mylar Wrap, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0015-2024·2023-03-22

    Shaw's Albacore Tuna Salad Wrap Recalled for Listeria Contamination

    Fresh Creative Cuisine is recalling Shaw's Albacore Tuna Salad Wrap due to potential Listeria monocytogenes contamination. The product was distributed across multiple eastern and mid-Atlantic states.

    Product
    Shaw's, Albacore Tuna Salad Wrap, Net . Wt. 9.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0517-2023·2023-03-22

    Bistro To Go Yogurt Parfait Recalled for Listeria Contamination

    Fresh Ideation Food Group is recalling Bistro To Go yogurt parfaits that may be contaminated with Listeria monocytogenes. Products sold January 24–30, 2023, were distributed across 11 states.

    Product
    Bistro To Go, Vanilla Low Fat Yogurt, Fruit & Granola Parfait, Net Wt. 9 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0021-2024·2023-03-22

    Naval Academy Bialy Products Recalled for Potential Listeria Contamination

    Fresh Ideation Food Group is recalling Naval Academy 1845 Bialy products (6.5 oz) sold January 24-30, 2023, due to potential Listeria monocytogenes contamination. Affected items were distributed to 11 states.

    Product
    Naval Academy 1845 Coffee, Ham, Swiss & Honey Mustard Bialy, Net . Wt. 6.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0524-2023·2023-03-22

    Fresh Creative Cuisine Blueberry Yogurt Parfait Recalled for Listeria Risk

    Fresh Creative Cuisine is recalling Blueberry Low Fat Yogurt Parfaits sold January 24–30, 2023, due to potential Listeria monocytogenes contamination. The recall affects products distributed to 11 states and Washington, DC.

    Product
    Fresh Creative Cuisine, Blueberry Low Fat Yogurt, Fruit & Granola Parfait, Net . Wt. 9 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0231-2024·2023-03-22

    Fresh Creative Cuisine Spicy Italian Super Hoagie Recalled for Listeria Risk

    Fresh Creative Cuisine is recalling Spicy Italian Super Hoagie sandwiches sold January 24–30, 2023 due to potential Listeria monocytogenes contamination. The recall affects 11 states.

    Product
    Fresh Creative Cuisine White Label, Spicy Italian Super Hoagie, Case of 6, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0148-2024·2023-03-22

    Fresh Creative Cuisine Ham & Swiss Pretzel Rolls Recalled for Listeria Risk

    Fresh Creative Cuisine Black Label Ham & Swiss Pretzel Rolls sold January 24–30, 2023, may be contaminated with Listeria monocytogenes. The product was distributed to 11 states.

    Product
    Fresh Creative Cuisine Black Label, Ham & Swiss Pretzel Roll, Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0168-2024·2023-03-22

    Fresh Creative Cuisine Italian Hoagie Recalled for Potential Listeria Contamination

    Fresh Ideation Food Group recalls Fresh Creative Cuisine Italian Hoagie sandwiches due to potential Listeria monocytogenes contamination. Products were distributed across multiple states from January 24-30, 2023.

    Product
    Fresh Creative Cuisine White Label, Italian Hoagie, Single Serve, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Food)·F-0197-2024·2023-03-22

    Fresh Cut Fruit Medley Recalled Due to Potential Listeria Contamination

    Fresh Creative Cuisine is recalling its Fresh Cut Fruit Medley (8 oz.) due to potential contamination with Listeria monocytogenes. The products were distributed across multiple states.

    Product
    Fresh Creative Cuisine White Label, Fresh Cut Fruit Medley, Net Wt. 8 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • SevereFDA (Devices)·Z-1190-2023·2023-03-22

    Closed Suction System Manifold Cracking Poses Respiratory Circuit Leak Risk

    Avanos Medical recalls BALLARD ACCESS Closed Suction System units due to manifold cracking, which can cause respiratory circuit leaks and inadequate ventilation in neonatal and pediatric patients.

    Product
    BALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1189-2023·2023-03-22

    BALLARD ACCESS Closed Suction System Manifold May Crack and Leak

    Avanos Medical is recalling 780 units of the BALLARD ACCESS Closed Suction System due to manifold cracking that can leak the respiratory circuit, potentially causing inadequate ventilation in neonatal and pediatric patients.

    Product
    BALLARD ACCESS Closed Suction System for Neonates/Pediatrics, Y-Manifold.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0527-2023·2023-03-22

    Fresh Creative Cuisine Chicken Salad Sandwiches Recalled for Listeria Risk

    Fresh Creative Cuisine chicken salad finger sandwiches sold January 24–30, 2023 are recalled due to potential Listeria monocytogenes contamination. The product was distributed to 11 states.

    Product
    Fresh Creative Cuisine, Chicken Salad Finger Sandwiches, Net . Wt. 6.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighNHTSA·23V190000·2023-03-22

    Alexis Fire Equipment Recalls 2022 Fire Apparatus Due to Winch Remote Defect

    Alexis Fire Equipment is recalling 2022 fire apparatus vehicles because water may enter the winch remote, causing corrosion and unintentional winch operation.

    Product
    ALEXIS FIRE EQUIPMENT — ALEXIS FIRE EQUIPMENT FIRE APPARATUS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0616-2023·2023-03-22

    Catalina Snacks Cheddar Snack Mix Recalled for Metal Contamination

    Catalina Snacks is recalling cheddar flavored snack mix due to metal foreign material contamination. Approximately 316,980 pouches with Best By dates of February 15 or 22, 2023 are affected.

    Product
    Cheddar flavored ready-to-eat snack mix packaged in 6oz (UPC 850017468160) plastic stand up pouch.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0607-2023·2023-03-22

    Sunflower Lecithin Powder Recalled for Undeclared Peanut Allergen

    Navada Imports is recalling sunflower lecithin powder in 44 lb. boxes due to an undeclared peanut allergen. The affected product poses a serious risk to consumers with peanut allergies.

    Product
    Sunflower Lecithin Powder Packaged in 44 lb. (20 kg.) boxes
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0437-2023·2023-03-22

    Dark Chocolate Wafer Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolater is recalling DF Dark Choc Flvd Wafer (Item #56810) in 50-pound cases because the product may contain undeclared peanut residue. Consumers with peanut allergies should not consume this product.

    Product
    DF Dark Choc Flvd Wafer (MB), Item # 56810. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Palm Kernel Oil, Cocoa Powder (processed with Alkali), Sunflower Lecithin (an emulsifier), Salt. Distributed By: Clasen Quality Chocolate, 5126 West Terrace Drive, M
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0429-2023·2023-03-22

    Milk Chocolate Wafers Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolate is recalling milk chocolate confectionery wafers due to potential undeclared peanut residue. Consumers with peanut allergies should not consume this product.

    Product
    Milk Choc Flvd Confectionery Wafer (HP, NSA), Item # 52546. Net Wt. 40 lbs. (18.14 KG) poly-lined case. Ingredients: Palm Kernal Oil, Whey Protein Isolate, Erythritol, Sodium Caseinate, Cocoa Powder (Processed with Alkali), Natural Flavor, Sunflower Lecithin (an emulsifier),
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0422-2023·2023-03-22

    Sheetz Ham Deli Sandwiches Recalled for Undeclared Sesame

    Sheetz is recalling M.T.go! Ham Deli Sandwiches that may contain undeclared sesame, a common allergen. The recall affects 5,715 sandwiches in PA, MD, OH, WV, NC, and VA.

    Product
    Sheetz M.T.go!, Made To Go Ham Deli Sandwich. The products are packaged in 4.75 oz. clear, plastic clamshells with the following UPC 759465001847 (Ham).
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0612-2023·2023-03-22

    Catalina Snacks fruit cereal recalled due to metal contamination

    Catalina Snacks is recalling fruit flavored ready-to-eat cereal in 1.27 oz and 8 oz pouches due to potential metal foreign material contamination. Consumers who purchased affected products should not consume them.

    Product
    Fruit flavored ready-to-eat cereal packaged in 1.27 oz. (UPC 850017468214) and 8oz. ( UPC 850017468085) plastic stand up pouch.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-1243-2023·2023-03-22

    BD Ultra-Fine Insulin Syringes Recalled Due to Nonsterile Condition

    Becton Dickinson is recalling BD Ultra-Fine Insulin Syringes (Catalog Number 326719) due to a nonsterile condition that could expose patients to pathogenic microorganisms and local infection. Approximately 80,500 units distributed worldwide are affected.

    Product
    BD Ultra-Fine Insulin Syringe 1mL, 12.7mm, 29G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326719
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0595-2023·2023-03-22

    Cafe' Intermezzo Cheesecake Recalled for Undeclared Hazelnut Allergen

    Epic Baking is recalling Cafe' Intermezzo Hazelnut Chocolate Cheesecake due to undeclared hazelnut sub-ingredient. The product was distributed to Georgia and Tennessee.

    Product
    Cafe' Intermezzo Hazelnut Chocolate Cheesecake 6 lbs Ingredients: Eggs, Cream Cheese, Sugar, Nutella, Cocoa Crust (Graham Crackers, Butter, Sugar, Cocoa Powder, Vanilla Extract), Vanilla Extract, Corn Starch. Contains: Milk, eggs, tree nuts, wheat and soy. May contain peanuts.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1260-2023·2023-03-22

    Bard Mission Disposable Core Biopsy Instrument Kit Recall: Sizing Incompatibility

    Bard Peripheral Vascular is recalling certain Bard Mission Disposable Core Biopsy Instrument Kits due to sizing incompatibility between the biopsy instrument and coaxial needle, which could cause procedural delays or needle breakage.

    Product
    Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0432-2023·2023-03-22

    Clasen Semisweet Chocolate Drops Recalled for Undeclared Peanut

    Clasen Quality Chocolate recalled 2M Semisweet Chocolate Drops due to undeclared peanut residue. Approximately 150,600 lbs distributed across 12 states.

    Product
    2M Semisweet Chocolate Drop, Item # 53700. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Unsweetened Chocolate, Sugar, Cocoa Butter, Dextrose, Sunflower Lecithin (an emulsifier), and Vanilla Extract. Distributed By: Clasen Quality Chocolate, 5126 West Terrace Dr
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-1256-2023·2023-03-22

    Ambulance cot may separate due to insufficient epoxy in assemblies

    Stryker's Power-PRO 2 ambulance cots may separate at head or foot due to insufficient epoxy. Four affected units in NY and VA should be removed from service immediately.

    Product
    Power-PRO 2 . Intended as an ambulance cot to transport a patient to or from an emergency or non-emergency location. Model: 650705550001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0206-2024·2023-03-22

    Roast Beef & Cheese Pretzel Rolls Recalled Due to Listeria Risk

    Fresh Creative Cuisine is recalling Roast Beef & Cheese Pretzel Rolls (6.5 oz) sold January 24-30, 2023, due to potential Listeria monocytogenes contamination. The product was distributed to eleven states including Maryland, Pennsylvania, New York, and others.

    Product
    Fresh Creative Cuisine White Label, Roast Beef & Cheese Pretzel Roll, Net . Wt. 6.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-1259-2023·2023-03-22

    Radiation Therapy Software May Not Properly Execute Heart-Protection Breath Hold

    Brainlab ExacTrac Dynamic software used in charged-particle radiation therapy systems may not properly execute Deep Inspiration Breath Hold (DIBH) functionality, a heart-protection technique. The issue affects 56 systems across the United States.

    Product
    Brainlab ExacTrac Dynamic software, Medical Charged-Particle Radiation Therapy System, model 20910-01E and 20910-01F.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1246-2023·2023-03-22

    Synthes TFN-Advanced Femoral Nail Recalled for Dimensional Labeling Mismatch

    Synthes (USA) Products LLC is recalling TFN-Advanced Femoral Nails because labeled measurements do not match actual dimensions. Nails labeled 200mm may be 170mm and vice versa.

    Product
    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.213S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0614-2023·2023-03-22

    Catalina Snacks Honey Graham Cereal Recalled for Metal Contamination

    Catalina Snacks is recalling approximately 316,980 pouches of Honey Graham flavored cereal (UPC 860479001553) due to metal fragments. The affected product with a best-by date of 7/25/2023 was distributed online and across 21 states.

    Product
    Honey Graham flavored ready-to-eat cereal packaged in 9oz (UPC 860479001553) plastic stand up pouch.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0615-2023·2023-03-22

    Maple Waffle Cereal Recalled Due to Metal Contamination

    Catalina Snacks is recalling Maple Waffle flavored ready-to-eat cereal due to the potential presence of metal fragments. Consumers should not consume the affected product.

    Product
    Maple Waffle flavored ready-to-eat cereal packaged in 9oz (UPC 860479001539) plastic stand up pouch.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0442-2023·2023-03-22

    Chocolate wafer product recalled for undeclared peanut residue

    Clasen Quality Chocolate is recalling DF ANSA chocolate wafers because the product may contain undeclared peanut residue, posing a risk to consumers with peanut allergies.

    Product
    DF ANSA Choc Flvd Conf Wafer (MB), Item # 59154. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Soluble Corn Fiber, Palm Kernel and Palm Oil, Allulose, Cocoa Powder (Processed with Alkali), Chocolate Liquor, Sunflower Lecithin (an emulsifier), Monk Fruit Extract. D
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0583-2023·2023-03-22

    Celestial Seasonings Mandarin Orange Spice Tea Contains Undeclared Caffeine

    Celestial Seasonings Mandarin Orange Spice herbal tea K-cups contain undeclared caffeine from black tea. The recall affects 1,844 units distributed nationwide.

    Product
    Celestial Seasonings Mandarin Orange Spice Herbal Tea in K-cup pods; packed 24 to a box
    Category
    Food
    Distribution
    42 states
  • HighFDA (Food)·F-0443-2023·2023-03-22

    NGMO Ballard Semisweet Chocolate Wafer Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolater is recalling NGMO Ballard Semisweet Chocolate Wafer due to possible undeclared peanut residue. Consumers with peanut allergies who may have purchased this product should not consume it.

    Product
    NGMO Ballard Semisweet Chocolate Wafer, Item # 59343. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Chocolate Liquor (Processed with Alkali), Sugar, Cocoa Butter, Butterfat (Milk), Sunflower Lecithin (an emulsifier), Vanilla Extract. Distributed By: Clasen Quali
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0434-2023·2023-03-22

    Chocolate Confection Drops Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolate recalls 1M HP NSA Dark Chocolate Flavored Confection Drops due to potential undeclared peanut residue. Affected lot numbers 2308CH43CL15 and 2308CH44CL15 were distributed across multiple states. Consumers with peanut allergies should not consume this product.

    Product
    1M HP NSA Dark Choc Flvd Conf Drop, Item # 55969. Net Wt. 40 lbs. (18.14 KG) poly-lined case. Ingredients: Chocolate Liquor, Erythritol, Whey Protein Isolate, Cocoa Butter, Sodium Caseinate, Sunflower Lecithin (an emulsifier), Salt, Natural Flavor, Stevia Leaf Reb M. Distri
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0605-2023·2023-03-22

    Cheesecake Recalled for Undisclosed Almond Allergen on Label

    Epic Baking recalls Cafe' Intermezzo Amaretto Cheesecakes because the label fails to disclose almonds in the ingredient list despite containing almonds. The label only states 'may contain tree nuts.'

    Product
    Cafe' Intermezzo White Chocolate Amaretto Cheesecake 7 lbs Ingredients: Eggs, Cream Cheese, Sugar, Amaretto Syrup, Whipped Cream, Almond Crust (Graham Crackers, Butter, Sugar, Almonds, Vanilla Extract), Vanilla Extract, White Chocolate, Almond Extract, Corn Starch. Contains: Milk
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0560-2023·2023-03-22

    Mediterranean Hummus and Veggie Ficelle Recalled for Potential Listeria Contamination

    Fresh Creative Cuisine is recalling Mediterranean Hummus & Veggie Ficelle (6.4 oz) sold January 24-30, 2023, due to potential contamination with Listeria monocytogenes. The product was distributed across multiple Eastern states.

    Product
    Fresh Creative Cuisine, Mediterranean Hummus & Veggie Ficelle, Net . Wt. 6.4 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0436-2023·2023-03-22

    Chocolate Confectionery Drops Recalled Due to Undeclared Peanut Residue

    Clasen Quality Chocolater is recalling 4M Cinnamon Flvd Confectionery Drops because the chocolate may contain undeclared peanut residue. Consumers with peanut allergies should not consume this product.

    Product
    4M Cinnamon Flvd Confectionery Drop (MB), Item # 56466. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Palm Kernel Oil, Nonfat Dry Milk, Ground Cinnamon, Sunflower Lecithin (an emulsifier). Distributed By: Clasen Quality Chocolate, 5126 West Terrace Drive,
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-1254-2023·2023-03-22

    Amicus MNC Apheresis Kit at Risk of Stress Leak in Centrifuge Packs

    Fenwal Inc is recalling certain batches of the Amicus MNC Apheresis Kit due to a potential for centrifuge packs to develop stress leaks. Affected units were distributed nationwide and internationally.

    Product
    Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multiprocedural apheresis platform
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2023·2023-03-22

    Hair Growth Laser Comb Recalled for Missing Safety Warnings and Labels

    OMM Imports' Recreo Hair Growth Laser Comb is being recalled because 1,620 units lack required safety labels, warnings, and certification documentation. Missing labels create risk for users of the Class 3R laser device.

    Product
    Recreo Hair Growth Laser Comb
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1258-2023·2023-03-22

    Dimension Tacrolimus Diagnostic Cartridge Recalled for Measurement Imprecision

    Siemens is recalling Dimension Tacrolimus diagnostic test cartridges (lots GA2286, GA3047, GA3171) due to confirmed measurement imprecision that could lead to incorrect drug dosing and potential organ failure or toxicity.

    Product
    Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension¿ clinical chemistry system SMN: 10700795 (DF207)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0581-2023·2023-03-22

    Coffee pods with undeclared peanut residue being recalled

    Two Rivers Coffee is recalling Brooklyn Bean Peanut Butter Cup Hot Cocoa pods because they may contain undeclared peanut residue. Consumers with peanut allergies should not use affected pods.

    Product
    Brooklyn Bean Peanut Butter Cup Hot Cocoa packaged in single serve pods. Pods are packaged in the following Brooklyn Beans Variety Pack boxes: Brooklyn Beans Hot Chocolate Variety Pack Pods, 12 Count UPC:810683021977 Brooklyn Beans Brooklyn Beans Peanut Butter Chocolate Hot Coc
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0146-2024·2023-03-22

    Dietz & Watson Ham & Swiss Half Sub Recall for Potential Listeria Contamination

    Fresh Creative Cuisine is recalling Dietz & Watson Ham & Swiss Half Sub Single Serving products due to potential Listeria monocytogenes contamination. The affected products were sold January 24-30, 2023, and distributed to eastern U.S. states.

    Product
    Dietz & Watson, Ham & Swiss Half Sub Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0495-2023·2023-03-22

    Bistro To Go Flatbread Recall: Potential Listeria Contamination

    Fresh Ideation Food Group is recalling Bistro To Go Mango Habanero BBQ Chicken Flatbread due to potential Listeria monocytogenes contamination in products sold January 24-30, 2023.

    Product
    Bistro To Go, Mango Habanero Bbq Chicken Flatbread, Net Wt. 9 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Drugs)·D-0469-2023·2023-03-22

    Eye allergy medication recalled for out-of-specification impurity

    Teva Pharmaceuticals is recalling 715,632 bottles of Clear Eyes Once Daily eye drops due to an out-of-specification impurity found during stability testing.

    Product
    Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC 67
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0459-2023·2023-03-22

    Alprazolam Tablets Recalled Due to Potential Cross-Contamination Risk

    Breckenridge Pharmaceutical is recalling multiple lots of Alprazolam 0.5mg tablets nationwide due to manufacturing process deviations that created a potential cross-contamination risk.

    Product
    Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1,000-count bottle (NDC 51991-0705-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: B
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0048-2024·2023-03-22

    Bistro Garden Salad Recalled for Potential Listeria Contamination

    Fresh Ideation Food Group is recalling Quick & Fresh Bistro Garden Salad with Dressing due to potential Listeria monocytogenes contamination. The product was sold from January 24-30, 2023, in 11 states.

    Product
    Quick & Fresh, Bistro Garden Salad with Dressing, Net Wt. 5.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0610-2023·2023-03-22

    Soybean Lecithin Powder Recalled for Undeclared Peanut Allergen

    Navada Imports is recalling 575 cases of soybean lecithin powder due to undeclared peanut allergen. Affected products were distributed nationwide to manufacturers.

    Product
    Soybean Lecithin Powder Packaged in 44 lb. (20 kg.) boxes
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1245-2023·2023-03-22

    Fusion Bioline Vascular Graft recalled due to manufacturing straightness defect

    Maquet Cardiovascular is recalling one Fusion Bioline Vascular Graft from lot 25162546 that failed straightness testing. The graft could reduce blood flow or cause tension, potentially leading to bleeding and pseudo-aneurysm.

    Product
    Fusion Bioline Vascular Graft, Part number M00201503046B0
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0461-2023·2023-03-22

    Alprazolam Tablets Recalled for Potential Cross-Contamination from Manufacturing Deviations

    Breckenridge Pharmaceuticals is recalling Alprazolam 2 mg tablets nationwide due to manufacturing practice deviations creating potential cross-contamination risk. Affected tablets are distributed in 100-count and 500-count bottles.

    Product
    Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 51991-0707-05), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0435-2023·2023-03-22

    White Confectionery Chocolate Drop May Contain Undeclared Peanut Residue

    Clasen Quality Chocolater is recalling 4M White Confectionery Drop MB chocolate because it may contain undeclared peanut residue. Peanut allergen poses a risk to consumers with peanut allergies.

    Product
    4M White Confectionery Drop MB, Item # 56464. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Palm Kernel Oil, Nonfat Dry Milk, Whole Milk Powder, Whey Powder (Milk) Palm Oil, Sunflower Lecithin (an emulsifier), Vanilla Extract. Distributed By: Clasen Quali
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0428-2023·2023-03-22

    White Confectionery Coating Wafer Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolater is recalling 20,360 lbs of white confectionery coating wafer due to possible undeclared peanut residue that poses a risk to consumers with peanut allergies.

    Product
    White Confectionery Coating Wafer (HP, NSA), Item # 52544. Net Wt. 40 lbs. (18.14 KG) poly-lined case. Ingredients: Palm Kernal Oil, Whey Protein Isolate, Erythritol, Sodium Caseinate, Sunflower Lecithin (an emulsifier), Salt, and Sucralose. Distributed By: Clasen Quality
    Category
    Food
    Distribution
    12 states
  • HighFDA (Drugs)·D-0463-2023·2023-03-22

    Clobazam Tablets Recalled Due to Cross Contamination Risk

    Breckenridge Pharmaceutical is recalling Clobazam 20 mg tablets (Lot #5210147, exp. 12/2023) nationwide due to potential cross contamination from manufacturing deviations.

    Product
    Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-901-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0604-2023·2023-03-22

    Chocolate torte recalled for undeclared milk, eggs, wheat, and soy

    Epic Baking recalled approximately 226 Cafe' Intermezzo Triple Chocolate Tortes due to missing ingredient statements. The product contains undeclared milk, eggs, wheat, soy, and Red 40 dye.

    Product
    Cafe' Intermezzo Triple Chocolate Torte 5.38 lbs Smooth and silky triple chocolate torte baked with chocolate cake and iced with our very own chocolate buttercream frosting and chocolate ganache.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1238-2023·2023-03-22

    BD Insulin Syringes Recalled Due to Nonsterile Condition

    BD Insulin Syringes (Catalog 329420) are being recalled due to nonsterile conditions that could expose patients to pathogenic microorganisms and increase infection risk. The recall affects 961,000 units distributed worldwide.

    Product
    BD Insulin Syringes with the BD Micro-Fine TM IV Needle 1ml, 12.7mm, 28G Single Unit Scale. Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329420
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0441-2023·2023-03-22

    38% Cacao Milk Chocolate Wafers Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolater has recalled 38% Cacao Milk Chocolate Wafers due to undeclared peanut residue. Consumers with peanut allergies should not consume the product.

    Product
    38% Cacao Milk Chocolate Wafer (RA MB), Item # 58873. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Cocoa Butter, Milk, Chocolate Liquor, Sunflower Lecithin (an emulsifier), Vanilla Extract. Distributed By: Clasen Quality Chocolate, 5126 West Terrace Drive
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0147-2024·2023-03-22

    Ready-to-Eat Ham & Swiss Panini Recalled for Potential Listeria Contamination

    Quick & Fresh ham and Swiss panini products may be contaminated with Listeria monocytogenes. FDA Class I recall affects multiple states; consumers should discard the product.

    Product
    Quick & Fresh, Ham & Swiss Panini, Net . Wt. 7.7 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0536-2023·2023-03-22

    Fresh Creative Cuisine Fresh Cut Fruit Medley recalled for potential Listeria contamination

    Fresh Creative Cuisine is recalling its Fresh Cut Fruit Medley products due to potential Listeria monocytogenes contamination. The products were distributed across 11 states from January 24–30, 2023.

    Product
    Fresh Creative Cuisine, Fresh Cut Fruit Medley, Net . Wt. 8 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0584-2023·2023-03-22

    Bakery Torte Recalled for Undeclared Espresso and Food Dyes

    Epic Baking recalls Café Intermezzo Amaretto White Chocolate Tortes due to undeclared sub-ingredients: espresso, Yellow 5, and Yellow 6. These ingredients pose a risk to consumers with sensitivities.

    Product
    Cafe' Intermezzo Amaretto White Chocolate Torte 6.37 lbs Ingredient: White cake mix, vegetable oil, Amaretto syrup, Almond Extract, White chocolate flavor, Icing (Butter, Sugar, Amaretto syrup, Almond Extract, Vanilla Extract, white chocolate), Contains: Milk, eggs, wheat, soy an
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0611-2023·2023-03-22

    Danone YoCrunch Vanilla Yogurt recalled for undeclared wheat allergen

    Danone US LLC is recalling YoCrunch Vanilla Lowfat Yogurt because the product contains undeclared wheat, which poses a risk to consumers with wheat allergies.

    Product
    YoCrunch Vanilla Lowfat Yogurt with M&Ms 6 oz (170g) UPC 046675000792 packaged in plastic cup with self-contained plastic dome attached on top, 12 cups per case
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1242-2023·2023-03-22

    BD Insulin Syringes Recalled for Nonsterile Condition and Infection Risk

    Becton Dickinson is recalling 686,500 units of BD insulin syringes due to a nonsterile condition that may expose patients to pathogenic microorganisms and risk of infection.

    Product
    BD Insulin Syringes with the BD Micro-Fine IV Needle 0.5ml, 12.7mm, 28G Single Unit Scale-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329461
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0613-2023·2023-03-22

    Chocolate Peanut Butter cereal recalled due to metal contamination

    Catalina Snacks is recalling Chocolate Peanut Butter cereal (9oz pouches) due to metal contamination. The recall affects approximately 316,980 pouches distributed across multiple states and online retailers.

    Product
    Chocolate Peanut Butter flavored ready-to-eat cereal packaged in 9oz (UPC 850017468184) plastic stand up pouch.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0597-2023·2023-03-22

    Key Lime Cheesecake recalled for undeclared food dyes

    Epic Baking is recalling Key Lime Cheesecake containing undeclared Yellow 5 and Blue 1 food dyes distributed to Georgia and Tennessee. Consumers with sensitivities may experience adverse reactions.

    Product
    Cafe' Intermezzo Key Lime Cheesecake 6.5 lbs Ingredients: Cream Cheese, Eggs, Sugar, Key Lime Mixture, Whipped Cream, Graham Cracker Crust (Graham Cracker Crumbs, Butter, Sugar, Vanilla Extract, Cinnamon), Key Lime Glaze (All-Purpose Flour, Nelly's Key Lime Juice, Vanilla Extract
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1237-2023·2023-03-22

    BD Ultra-Fine Insulin Syringe Recall Due to Nonsterile Manufacturing

    Becton Dickinson is recalling 45,000 units of BD Ultra-Fine Insulin Syringes (catalog 326679, lot 2164338) due to nonsterile manufacturing that could expose patients to pathogenic microorganisms and local infection. Distribution was worldwide.

    Product
    BD Ultra-Fine Insulin Syringe 0.5mL, 6mm, 31G - Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326679
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2023·2023-03-22

    BD Insulin Syringes Recalled for Potential Nonsterile Condition

    Becton Dickinson & Company is recalling 1.17 million BD Ultra-Fine Insulin Syringes due to a nonsterile manufacturing defect that could expose patients to pathogenic microorganisms and increase infection risk.

    Product
    BD Ultra-Fine Insulin Syringe 1mL, 6mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326678
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0076-2024·2023-03-22

    Chocolate Pudding Delight Recalled for Potential Listeria Contamination

    Quick & Fresh Chocolate Pudding Delight products sold January 24-30, 2023 are being recalled for potential Listeria monocytogenes contamination with no reported illnesses. Affected units were distributed to multiple Mid-Atlantic and Eastern states.

    Product
    Quick & Fresh, Chocolate Pudding Delight, Net Wt. 6.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-1250-2023·2023-03-22

    Arial mobile application recalled for Android loading failures

    Securitas Healthcare is recalling the Arial mobile application for Android devices because the app does not load or function properly. Users should stop using the app immediately.

    Product
    Arial mobile application, model #54630 and #54640 for Android devices downloaded from the Google Play Store as part of the Arial Emergency and Nurse Call system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1257-2023·2023-03-22

    Beckman Coulter Access Immunoassay Analyzers Recalled for Defective Nut Bands

    Beckman Coulter is recalling approximately 4,100 laboratory immunoassay analyzers due to defective nut bands that may cause operational failures and erroneous patient test results.

    Product
    Access Immunoassay Systems (1) Access 2 Immunoassay Analyzer (81600N); (2) Access 2 Immunoassay Analyzer, Refurbished (386220); (3) Access 2 Immunoassay Analyzer, Refurbished (A65531) ; and (4) Access 2 Section, DxC 600i Packaged(A25640).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0507-2023·2023-03-22

    Bistro To Go Yogurt Parfait Recalled for Listeria Contamination

    Fresh Creative Cuisine is recalling Bistro To Go Strawberry Low Fat Yogurt Parfait cups sold in January 2023 due to potential Listeria monocytogenes contamination. No illnesses have been reported.

    Product
    Bistro To Go, Strawberry Low Fat Yogurt, Fruit & Granola Parfait, Net Wt. 5.5 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0617-2023·2023-03-22

    Creamy Ranch Snack Mix Recalled for Metal Contamination

    Catalina Snacks recalls Creamy Ranch flavored snack mix due to metal contamination. Consumers who have this product should not eat it.

    Product
    Creamy Ranch flavored ready-to-eat snack mix packaged in 6oz (UPC 850017468160) plastic stand up pouch.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Food)·F-0582-2023·2023-03-22

    Pingo Hot Chocolate Pods Recalled for Undeclared Peanut Residue

    Pingo hot chocolate pods may contain undeclared peanut residue. Consumers with peanut allergies should not consume affected products.

    Product
    Pingo Peanut Butter Cookie Hot Chocolate packaged in single serve pods. Pods are packaged in the following Pingo Variety Pack boxes: Pingo Hot Chocolate Pods Variety Pack, 40 Count UPC: 810683028150 Pingo Hot Chocolate Pods Variety Pack, 100 Count UPC: 810683029805 Pingo Hot Ch
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0439-2023·2023-03-22

    Semisweet Chocolate Wafer Recalled for Undeclared Peanut Residue

    Clasen Quality Chocolater recalls semisweet chocolate wafers due to undeclared peanut residue that may pose a risk to consumers with peanut allergies. The recall affects 20,000 lbs across 12 states.

    Product
    Semisweet Chocolate Wafer (FT), Item # 56992. Net Wt. 25 lbs. (11.34 KG) poly-lined case. Ingredients: Sugar, Chocolate Liquor, Cocoa Butter, Sunflower Lecithin (an emulsifier), Vanilla Extract. Distributed By: Clasen Quality Chocolate, 5126 West Terrace Drive, Madison, WI
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0157-2024·2023-03-22

    Hard Boiled Eggs and Crackers Recalled for Potential Listeria Monocytogenes Contamination

    Fresh Creative Cuisine is recalling Hard Boiled Eggs & Crackers due to potential Listeria monocytogenes contamination. The affected products were sold January 24-30, 2023, in 11 states.

    Product
    Fresh Creative Cuisine White Label, Hard Boiled Eggs & Crackers, Net . Wt. 2.9 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0426-2023·2023-03-22

    DF FT Simple Free Dark Wafer chocolate recalled for undeclared peanut residue

    Clasen Quality Chocolater is recalling DF FT Simple Free Dark Wafer chocolate because it may contain undeclared peanut residue. Consumers with peanut allergies should not consume this product.

    Product
    DF FT Simple Free Dark Wafer (MB), Item # 12957. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Palm Kernal Oil, Cocoa Powder, Sunflower Lecithin (an emulsifier), and Salt. Distributed By: Clasen Quality Chocolate, 5126 West Terrace Drive, Madison, WI 537
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0431-2023·2023-03-22

    Semisweet Chocolate Drops Recalled Due to Undeclared Peanut Residue

    Clasen Quality Chocolater, Inc. is recalling 4M Simply Free Semisweet Chocolate Drops because the chocolate may contain undeclared peanut residue, posing a serious risk to consumers with peanut allergies.

    Product
    4M Simply Free Semisweet Chocolate Drop (FT), Item # 53385. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Chocolate Liquor, Cocoa Butter, Sunflower Lecithin (an emulsifier), and Vanilla Extract. Distributed By: Clasen Quality Chocolate, 5126 West Terrace
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0423-2023·2023-03-22

    Sheetz M.T.go Turkey Deli Sandwich recalled for undeclared sesame allergen

    Sheetz Distribution Services is recalling 10,361 M.T.go Turkey Deli Sandwiches due to undeclared sesame. Consumers with sesame allergies face potential serious allergic reactions.

    Product
    Sheetz M.T.go! Made To Go Turkey Deli Sandwich. The products are packaged in 4.75 oz. clear, plastic clamshells with the following UPC 759465001854 (Turkey).
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0438-2023·2023-03-22

    Chocolate Baking Chips Recalled Due to Undeclared Peanut Residue

    Clasen Quality Chocolater has recalled 4M DF NSA Semisweet Baking Drop chocolate due to potential undeclared peanut residue. The product may pose a risk to consumers with peanut allergies.

    Product
    4M DF NSA Semisweet Baking Drop (FT), Item # 56854. Net Wt. 40 lbs. (18.14 KG) poly-lined case. Ingredients: Chocolate Liquor, Inulin, Erythritol, Cocoa Butter, Sunflower Lecithin (an emulsifier), Vanilla Extract, Stevia Leaf Reb M. Distributed By: Clasen Quality Chocolate
    Category
    Food
    Distribution
    12 states
  • HighFDA (Food)·F-0621-2023·2023-03-22

    Frozen Wonton Wrappers Recalled Due to Peanut Contamination in Sub-Ingredient

    Bailey International Foods is recalling 4" x 4" and 3.5" x 3.5" frozen wonton wrappers due to peanut contamination in a sub-ingredient. The product was distributed to wholesalers in 19 states.

    Product
    Wonton wrappers, 4" x 4" and 3.5" x 3.5", packaged in 30lb. corrugated (cardboard) boxes. Product is sold frozen.
    Category
    Food
    Distribution
    19 states
  • HighFDA (Food)·F-0035-2024·2023-03-22

    Orchard Bistro Asian Style Noodle Bowl Recalled for Listeria

    Orchard Bistro Asian Style Noodle Bowls sold January 24-30, 2023 are recalled for potential Listeria monocytogenes contamination. Products were distributed across 11 states.

    Product
    Orchard Bistro, Asian Style Noodle Bowl, Net Wt. 12 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0599-2023·2023-03-22

    Cake Recalled for Undeclared Milk, Egg, Wheat, and Soy Allergens

    Epic Baking recalls Cafe' Intermezzo Party Time Torte due to missing ingredient statement. The cake contains undeclared allergens: milk, egg, wheat, and soy.

    Product
    Cafe' Intermezzo Party Time Torte 5.31 lbs Two Layers of rich vanilla cake filled with Butter cream! Decorated With sprinkles.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1261-2023·2023-03-22

    TEMA Axle Small elbow prosthesis recalled due to unapproved component

    Limacorporate recalled 5 TEMA Axle Small elbow prostheses due to inclusion of a component not cleared for U.S. marketing. Affected systems were distributed to Texas.

    Product
    TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1247-2023·2023-03-22

    TFN-Advanced Femoral Nails May Have Incorrect Length Markings

    Synthes TFN-Advanced Femoral Nails labeled as 200mm may measure 170mm, and vice versa. Healthcare providers should verify actual dimensions before surgical use.

    Product
    TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 170MM - STERILE. Intended for temporary fixation and stabilization of proximal femur fractures. Part Number: 04.037.212S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0099-2024·2023-03-22

    Fresh Cut Fruit Medley Recalled for Potential Listeria Contamination

    FRESH IDEATION FOOD GROUP is recalling Quick & Fresh Fresh Cut Fruit Medley due to potential Listeria monocytogenes contamination. The 8 oz. single-serving packages were distributed to 11 states from January 24-30, 2023.

    Product
    Quick & Fresh, Fresh Cut Fruit Medley, Net . Wt. 8 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Devices)·Z-1249-2023·2023-03-22

    Plato 17 Microcatheter Recalled Due to Loose Particle Risk

    Scientia Vascular is recalling Plato 17 Microcatheters due to manufacturing defects that may introduce loose particles into the catheter lumen, potentially causing blood vessel blockage or inflammatory reactions.

    Product
    Plato 17 Microcatheter: Straight Tip, PL17-160-000 ; 45 degree Tip, PL17-160-045; 90 degree Tip, PL17-160-090
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0618-2023·2023-03-22

    Spicy Kick snack mix recalled due to potential metal contamination

    Catalina Snacks is recalling Spicy Kick ready-to-eat snack mix pouches due to potential metal contamination. The product was distributed across multiple U.S. states and online sales.

    Product
    Spicy Kick flavored ready-to-eat snack mix packaged in 6oz (UPC 850017468153) plastic stand up pouch.
    Category
    Food
    Distribution
    21 states
  • HighFDA (Devices)·Z-1239-2023·2023-03-22

    BD Insulin Syringes Recalled for Sterility Defect

    Becton Dickinson recalls 1.9 million BD Insulin Syringes due to a nonsterility defect that could expose patients to pathogenic microorganisms and local infection risk.

    Product
    BD Insulin Syringes with the BD Micro-Fine IV Needle 1 ml, 12. 7mm, 28G Two Unit Scale- Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 329424
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0458-2023·2023-03-22

    Alprazolam Tablets Recalled for Potential Cross-Contamination Risk

    Breckenridge Pharmaceuticals is recalling Alprazolam Tablets, USP 0.25mg distributed nationwide due to a potential cross-contamination risk from manufacturing deviations.

    Product
    Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1,000-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berli
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2023·2023-03-22

    BD Ultra-Fine Insulin Syringe 0.5mL Recalled for Nonsterility Risk

    Becton Dickinson is recalling approximately 1.1 million BD Ultra-Fine Insulin Syringes due to nonsterility concerns. The affected syringes may expose patients to pathogenic microorganisms and risk of local infection.

    Product
    BD Ultra-Fine Insulin Syringe 0.5mL, 8mm, 31G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326713
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0589-2023·2023-03-22

    Cafe' Intermezzo Carrot Torte Recalled for Undeclared Food Colorants

    Epic Baking is recalling Cafe' Intermezzo Carrot Torte because the product contains undeclared food colorants Yellow 5 and Red 40. The product was distributed in Georgia and Tennessee.

    Product
    Cafe' Intermezzo Carrot Torte 5.5 lbs Ingredients: Yellow Cake, Water, Carrots, Dark Brown Sugar, Vegetable Oil, Pecans, Walnuts, Cinnamon, Nutmeg, Allspice, Salt. Contains: Milk, eggs, tree nuts, wheat and soy, May contain peanuts.
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0440-2023·2023-03-22

    Milk Chocolate Drop Recalled Due to Undeclared Peanut Residue

    Clasen Quality Chocolate is recalling 4M Milk Chocolate Drop items because they may contain undeclared peanut residue. The product was distributed across multiple states.

    Product
    4M Milk Chocolate Drop, Item # 57667. Net Wt. 50 lbs. (22.68 KG) poly-lined case. Ingredients: Sugar, Whole Milk, Chocolate Liquor, Cocoa Butter, Milk Fat, Sunflower Lecithin (an emulsifier), Vanilla Extract. Distributed By: Clasen Quality Chocolate, 5126 West Terrace Driv
    Category
    Food
    Distribution
    12 states
  • HighFDA (Devices)·Z-1244-2023·2023-03-22

    BD Ultra-Fine II insulin syringes recalled for sterility defect

    Becton Dickinson recalled 1,472,400 BD Ultra-Fine II insulin syringes due to a sterility defect. The nonsterile syringes pose a risk of local infection at injection sites.

    Product
    BD Ultra-Fine II Insulin Syringe 0.5mL, 8mm, 30G-Insulin Syringes are designed for administering insulin in the treatment of diabetes mellitus. Catalog Number: 326725
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1248-2023·2023-03-22

    TFN Femoral Nails dimensions mislabeled, may measure 170mm or 200mm

    Synthes recalled TFN-Advanced Femoral Nails because some units have incorrect dimensions: nails labeled 200mm may measure 170mm, while those labeled 170mm may measure 200mm. This dimensional mismatch could compromise surgical fixation.

    Product
    TFN-Advanced Femoral Nail 12MM/130 DEG TI CANN TFNA 170MM STERILE. Intended for temporary fixation and stabilization of proximal femur fractures Part Number: 04.037.242S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0562-2023·2023-03-22

    Fresh Creative Cuisine Rainbow Berry & Nut Salad recalled for Listeria

    Fresh Creative Cuisine is recalling its Rainbow Berry & Nut Salad due to potential Listeria monocytogenes contamination. Products were distributed from January 24-30, 2023.

    Product
    Fresh Creative Cuisine, Rainbow Berry & Nut Salad W/Dressing, Net . Wt. 8.7 Oz. Single Serving, Keep refrigerated
    Category
    Food
    Distribution
    11 states
  • HighFDA (Food)·F-0608-2023·2023-03-22

    Sunflower Lecithin Liquid Products Recalled for Undeclared Peanut Allergen

    Navada Imports is recalling sunflower lecithin liquid in bulk totes due to undeclared peanut allergen. The affected products were distributed nationwide to food manufacturers.

    Product
    Sunflower Lecithin Liquid Packaged in 2,200 lb. (1,000 kg.) totes
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0460-2023·2023-03-22

    Alprazolam Tablets Recalled for Potential Cross-Contamination from Manufacturing Deviations

    Breckenridge Pharmaceutical is recalling Alprazolam 1 mg tablets distributed nationwide due to manufacturing practice deviations that pose a potential cross-contamination risk.

    Product
    Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Bre
    Category
    Drug
    Distribution
    Distributed nationwide

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