The Recall Desk

Archive

January 2022 recalls

428 recalls were announced in January 2022.

What the numbers show

Critical
3
Severe
158
High
169
Moderate
91
Low
7

Of the 428 recalls this month scored against our rubric, 1% are Critical, 37% are Severe.

Which agencies issued them

201–300 of 428

  • HighFDA (Food)·F-0380-2022·2022-01-19

    Bosket Bread Sesame Buns Recalled for Undeclared Allergens

    Bosket Bread Company is recalling Sesame Buns (1–1.5 lbs) distributed in Washington because the packages lack ingredient statements, leaving wheat, milk, egg, soy, and sesame allergens undeclared.

    Product
    Sesame Buns, Bosket Bread brand. The Net weight of the products range from 1-1.5 lbs. No UPC. Product is packaged in food grade plastic bag with the black Bosket Bread logo sticker on the front, but without the ingredients statement affixed on a package.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0482-2022·2022-01-19

    Raw Nutrition Test Booster Capsules recalled for undeclared milk

    NutraCap Labs LLC is recalling Raw Nutrition Test Booster Capsules 240ct bottles because the product contains undeclared milk, a common allergen that may affect consumers with milk allergies or sensitivities.

    Product
    Raw Nutrition Test Booster Capsules 240ct Bottle UPC CODE
    Category
    Food
    Distribution
    26 states
  • HighFDA (Food)·F-0475-2022·2022-01-19

    First Finisher/Ouro Vitae Mito Male Cherry Limeade contains undeclared milk

    NutraCap Labs LLC is recalling First Finisher/Ouro Vitae Mito Male Cherry Limeade 16oz jars because they contain undeclared milk, a common allergen.

    Product
    First Finisher/Ouro Vitae Mito Male Cherry Limeade 16oz Jar NO UPC CODE
    Category
    Food
    Distribution
    26 states
  • HighFDA (Food)·F-0497-2022·2022-01-19

    Vaxxen Labs Norexx Lean Mass Capsules Recalled for Undeclared Milk

    NutraCap Labs is recalling Vaxxen Labs Norexx Lean Mass Agent Capsules (90ct bottle, UPC 0 612524 173315, Lot #2109041) because the product contains undeclared milk, which poses a risk to consumers with milk allergies.

    Product
    Vaxxen Labs Norexx Lean Mass Agent Capsules 90ct Bottle UPC CODE 0 612524 173315
    Category
    Consumer Product
    Distribution
    26 states
  • HighFDA (Devices)·Z-0485-2022·2022-01-19

    DePuy Joint Stem May Have Undersized Bore, Complicating Surgical Removal

    DePuy Orthopaedics has recalled 3 units of GLOBAL UNITE REV STEM SZ 8 due to an undersized spigot bore. Separation of the implant components may not be possible without surgical delay and/or bone damage.

    Product
    GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0492-2022·2022-01-19

    Flat Panel Detector May Display Abnormal Images During Surgical Procedures

    Canon Medical's flat panel detectors used in Alphenix surgical systems may display abnormal horizontal stripes and fail to recover by restarting, potentially causing operators to work without proper visual guidance during procedures.

    Product
    Flat Panel Detector, Model Number: TFP-800A, used with the Alphenix Systems, Item Numbers: INFX-8000V, INFX-8000C, INFX-8000F, and INFX-8000H.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0389-2022·2022-01-19

    Pie Dough Recall: Undeclared Wheat Allergen

    Local Fixe LLC is recalling frozen pie dough products because wheat is not declared on the label, even though flour—which contains wheat—is an ingredient. The recall affects 181 packages distributed in Oregon.

    Product
    Pie Dough are packaged two crusts per pack and sold frozen. They are wrapped in white butcher paper. The weight per package is 1.257 lbs/540 grams. The label is read in parts: "***Pie Dough*** Flour, Butter (cream, milk, salt), Organic Palm Shortening, water, salt ***www.local
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0387-2022·2022-01-19

    Dream Pops Cookie Dough Bites Recalled for Undeclared Milk Allergen

    Dream Pops 100% Plant-Based Cookie Dough Bites are being recalled because they contain undeclared milk allergen. The product was distributed nationwide in the US and Canada.

    Product
    100% Plant-Based Dream Pops Cookie Dough Bites UPC 854097008322
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0491-2022·2022-01-19

    Medtronic Perfusion Kits Recalled: Missing Endotoxin Testing

    Medtronic is recalling approximately 6,653 Custom Perfusion kits used in cardiac procedures because they were labeled as non-pyrogenic without completing required endotoxin testing.

    Product
    Medtronic Custom Perfusion kits, with the following product descriptions and corresponding model numbers: 1. CUSTOM PACK BB10Q85R FILTER (Model BB10Q85R); 2. CUSTOM PACK BB11C01R MIDI DEEP (Model BB11C01R); 3. CUSTOM PACK BB7H95R22 HYP MAIN (Model B7H95R22); 4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0470-2022·2022-01-19

    RefleXion Medical Radiotherapy System Recall Due to Dose Discrepancy

    Reflexion Medical is recalling three RefleXion X1 radiotherapy systems due to a potential dose discrepancy when delivering treatment in Feet First Supine patient orientation.

    Product
    RefleXion Medical Radiotherapy System - System Label: "*** refleXion REF RXM1000 ***" Physics Guide/Treatment Delivery User Manual/Treatment Planning User Manual: "RefleXion X1 Model: RXM1000"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0440-2022·2022-01-19

    Global Link ShredFX Mango Margarita Recalled for Undeclared Milk

    NutraCap Labs LLC is recalling Global Link ShredFX Mango Margarita beverage in 16 oz jars because the product contains undeclared milk, which poses a risk to consumers with milk allergies.

    Product
    Global Link ShredFX Mango Margaritan16oz Jar UPC CODE 9 34585 60024 42
    Category
    Food
    Distribution
    26 states
  • HighFDA (Food)·F-0376-2022·2022-01-19

    Bosket Bread English Muffin Bread Recalled for Missing Ingredient Labels

    Bosket Bread Company is recalling English Muffin Bread products distributed in Washington because packages lack ingredient statements, leaving consumers unable to identify potential allergens including wheat, milk, egg, soy, or sesame.

    Product
    English Muffin Bread, Bosket Bread brand. The Net weight of the products range from 1-1.5 lbs. No UPC. Product is packaged in food grade plastic bag with the black Bosket Bread logo sticker on the front, but without the ingredients statement affixed on a package.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0399-2022·2022-01-19

    Raw Vegan Protein Peanut Butter Recalled for Undeclared Coconut

    NutraCap Labs LLC is recalling Raw Vegan Protein Peanut Butter dietary supplement because it contains undeclared coconut, which poses a risk to consumers with coconut allergies.

    Product
    RAW VEGAN PROTEIN PEANUT BUTTER NET WEIGHT 2.04LBS (925 GRAMS) DIETARY SUPPLEMENT Other Ingredients: Pea Protein Isolate, Brown Rice Protein, ***Sunflower (Non-Dairy) Creamer, Salt, Steviol Glycoside (95%) Manufactured in the U.S.A. for RAW, 838 SW Federal Highway, Stuart, Florid
    Category
    Food
    Distribution
    26 states
  • HighFDA (Food)·F-0419-2022·2022-01-19

    BlakeFit Everyday All-in-one Lime Watermelon Recalled for Undeclared Milk

    NutraCap Labs LLC is recalling BlakeFit Everyday All-in-one Lime Watermelon 44oz jars because the product contains undeclared milk, which poses a risk to consumers with milk allergies.

    Product
    BlakeFit Everyday All-in-one Lime Watermelon 44oz Jar UPC CODE X002J9E9KD 323359000058
    Category
    Food
    Distribution
    26 states
  • HighFDA (Drugs)·D-0372-2022·2022-01-19

    Nitroglycerin Lingual Spray Recalled for Defective Delivery System

    Padagis US LLC is recalling Nitroglycerin Lingual Spray due to a defective delivery system that may prevent proper medication administration. The recall affects 11,868 bottles distributed nationwide.

    Product
    NITROGLYCERIN LINGUAL — NITROGLYCERIN LINGUAL (NITROGLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0474-2022·2022-01-19

    Computed Tomography System Software May Degrade Head Image Quality

    Siemens SOMATOM Edge Plus CT systems running software version VB20_SP5 may produce degraded head images, potentially leading to patient misdiagnosis.

    Product
    SOMATOM Edge Plus-Computed tomography system Model 1026700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0465-2022·2022-01-19

    Subdermal Needle Electrode Corkscrew Recall: Risk of Blue Hub Detachment

    Technomed Europe is recalling 117,672 disposable subdermal needle electrodes due to risk of the blue hub detaching, potentially leaving the needle in the patient's scalp.

    Product
    Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0466-2022·2022-01-19

    Proton Therapy System software startup allows test processes to contaminate clinical environment

    The Proteus 235 proton therapy system can start clinical processes while test processes are still running, potentially using test components in clinical treatments without user notification. This could impact patient treatment if versions differ.

    Product
    Proteus 235; Version: PTS-8 versions before PTS-8.7.2
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0488-2022·2022-01-19

    Orthopaedic Stem Implants Recalled for Undersized Bore Manufacturing Defect

    DePuy Orthopaedics is recalling approximately 870 GLOBAL UNITE STD STEM implants worldwide because an undersized spigot bore may prevent proper separation, causing potential surgical delay or bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0472-2022·2022-01-19

    CT Scanner Software Defect May Degrade Image Quality Nationwide

    Siemens SOMATOM Confidence CT scanners with software version VB20_SP5 may experience degraded head image quality, creating a potential risk of misdiagnosis. The recall affects 108 units distributed nationwide.

    Product
    SOMATOM Confidence -Computed tomography systems Model 10590100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0479-2022·2022-01-19

    Radiotherapy Planning Software BeamAdjust and VeriSoft Recalled for Measurement Errors

    PTW North America is recalling BeamAdjust 2.2 and VeriSoft 8.0 software due to measurement errors that can report incorrect radiation doses in patient treatment plans.

    Product
    Software BeamAdjust version 2.2, Catalog No: S070009 Software VeriSoft version 8.0, Catalog No: S080032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2022·2022-01-19

    LigaSure Blunt Tip Laparoscopic Sealer Devices Recalled for Jaw Opening Defect

    Covidien is recalling LigaSure Blunt Tip Laparoscopic Sealer/Divider devices (lot 11320187X) due to an assembly defect that may prevent the device jaws from opening after tissue application, creating a risk of bleeding and tissue injury.

    Product
    LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
    Category
    Medical Device
    Distribution
    0 states
  • HighCPSC·22054·2022-01-19

    FRIGG Silicone Pacifiers Recalled Due to Choking Hazard

    Mushie & Co is recalling about 333,725 FRIGG Silicone Pacifiers because the silicone nipple can detach from the plastic shield, posing a choking hazard. Eight detachments have been reported in the U.S. with no injuries.

    Product
    FRIGG Silicone Pacifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2022·2022-01-19

    OCT-Camera Laser Shut-Off Malfunction Poses Patient Safety Risk

    Haag-Streit OCT-Camera devices with automatic laser shut-off malfunction may fail to recognize when the laser is safely switched off, posing a potential safety risk.

    Product
    OCT-Camera 211 01 A1, Running software iOCT-Control 3 v1.4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0394-2022·2022-01-19

    Vemondo Vegan Coconut & Cocoa Dessert Cones Recall for Undeclared Milk

    Lidl US Operations is recalling Vemondo Vegan Coconut & Cocoa Non-Dairy Dessert Cones due to undeclared milk allergen. The product was distributed to retail stores in Maryland, Virginia, and Pennsylvania.

    Product
    Vemondo Vegan Coconut & Cocoa Non-Dairy Dessert Cones 4-3.7 fl ounces (110 mL) cones UPC 4 056489 468646
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0388-2022·2022-01-19

    Fresh Flour Tortillas Recalled for Undeclared Wheat Allergen

    Local Fixe LLC is recalling Fresh Flour Tortillas because wheat is not declared on the label, even though flour (a wheat product) is listed as an ingredient. This poses a risk to consumers with wheat allergies.

    Product
    Fresh Flour Tortillas are packaged in a clear Ziploc style plastic bag. The weight per package is 1.323 lbs/600 grams. The label is read in parts: "***Fresh Flour Tortillas ***Flour, water, organic palm shortening, salt, baking powder*** ww.localfixe.com***".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0447-2022·2022-01-19

    Hi-T Level Up Capsules recalled for undeclared milk allergen

    NutraCap Labs LLC is recalling Hi-T Level Up Capsules 120ct bottles because the product contains undeclared milk, a common allergen that poses a risk to consumers with milk allergies.

    Product
    Hi-T Level Up Capsules 120ct Bottle UPC CODE
    Category
    Food
    Distribution
    26 states
  • HighFDA (Food)·F-0378-2022·2022-01-19

    Bosket Bread Jalapeño Cheese Bread Recall: Undeclared Allergens

    Bosket Bread Company is recalling Jalapeño Cheese Bread sold in Washington because the packaging lacks an ingredient statement, leaving major allergens (wheat, milk, egg, soy, sesame) undeclared.

    Product
    Jalape¿o Cheese Bread, Bosket Bread brand. The Net weight of the products range from 1-1.5 lbs. No UPC. Product is packaged in food grade plastic bag with the black Bosket Bread logo sticker on the front, but without the ingredients statement affixed on a package.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0504-2022·2022-01-19

    Everything Swapples Recalled for Potential Plastic Contamination

    SWAP FOODS LLC is recalling Everything Swapples (11.14 oz) due to an ingredient that may be contaminated with small pieces of plastic. Affected product was distributed to retail stores in Pennsylvania and Wisconsin.

    Product
    Everything Swapples, Net Wt. 11.14 OZ, UPC 8 64390 00021 3
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0373-2022·2022-01-19

    Bosket Bread Cinnamon Rolls recalled for undeclared allergens

    Bosket Bread Company is recalling cinnamon rolls (1–1.5 lbs, packaged in plastic bags) distributed in Washington because the packages lack ingredient statements, leaving wheat, milk, egg, soy, and sesame allergens undeclared.

    Product
    Cinnamon Rolls, Bosket Bread brand. The Net weight of the products range from 1-1.5 lbs. No UPC. Product is packaged in food grade plastic bag with the black Bosket Bread logo sticker on the front, but without the ingredients statement affixed on a package.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0366-2022·2022-01-19

    Howling Cow Butter Almond Ice Cream recalled for undeclared allergens

    Howling Cow Butter Almond ice cream sold in North Carolina and South Carolina contains Cookie Dough Ice Cream with undeclared soy and wheat allergens. Consumers with allergies should not consume the product.

    Product
    butter almond HOWLING COW THE ICE CREAM OF NC STATE UNIVERSITY One Pint (473 ml) Ingredients: Milk, Cream, Sugar, Almonds***Stabilizer***Carmel Color and Natural Flavor. Contains milk, almonds Proudly distributed by Hunter Farms High Point, NC 27262 UPC 0 74336 65079 6
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0372-2022·2022-01-19

    Bosket Bread Cinnamon Bread Recall for Undeclared Allergens

    Bosket Bread Company is recalling Cinnamon Bread products distributed in Washington because the packages lack ingredient statements, making it impossible for consumers to identify potential allergens including wheat, milk, egg, soy, and sesame.

    Product
    Cinnamon Bread, Bosket Bread brand. The Net weight of the products range from 1-1.5 lbs. No UPC. Product is packaged in food grade plastic bag with the black Bosket Bread logo sticker on the front, but without the ingredients statement affixed on a package.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0484-2022·2022-01-19

    GLOBAL UNITE STD STEM orthopedic implant manufacturing defect recall

    DePuy Orthopaedics is recalling GLOBAL UNITE STD STEM orthopedic implants due to undersized spigot bore diameter that may prevent proper removal during revision surgery, risking surgical delay and bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2022·2022-01-19

    Hip Stem Component Recalled Due to Undersized Bore Diameter

    DePuy is recalling GLOBAL UNITE STD STEM SZ 6 orthopedic stems due to undersized spigot bore that may prevent safe removal during revision surgery, risking surgical delays and bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2022·2022-01-19

    Hip Stem Device Recalled Due to Undersized Bore Diameter Risk

    DePuy Orthopaedics recalls the GLOBAL UNITE STD STEM SZ 14 hip stem in 451 units worldwide due to undersized spigot bore diameter. The defect may prevent proper separation of the stem during surgery without surgical delay or bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2022·2022-01-19

    Philips wireless footswitches for Allura Xper and Azurion X-ray systems recalled for connection issues

    Philips wireless footswitches used with Allura Xper and Azurion X-ray systems may experience connection issues that interrupt fluoroscopic imaging during patient procedures. The recall affects 1,971 systems distributed worldwide.

    Product
    Wireless Footswtich used with the following Philips Allura Xper and Azurion Interventional Fluoroscopic X-ray System . Model Number: 722001, 722002, 722003, 722005, 722006, 722008, 722010, 722011, 722012, 722013, 722014, 722015, 722019, 722020, 722022, 722023, 722024, 722025, 72
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0478-2022·2022-01-19

    OCT Camera Laser Safety Shut-Off Malfunction Affects Three Units

    Haag-Streit USA is recalling OCT-Camera 211 01 A3 units due to malfunction of the automatic laser beam shut-off. The device may not correctly recognize when the laser beam is safely switched off.

    Product
    OCT-Camera 211 01 A3; Running software iOCT-Control 3 v1.4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0469-2022·2022-01-19

    Sterilized medical convenience kits recalled for missing latex warning label

    ROi CPS LLC is recalling 195 Regard T AND A - Rogers sterilized convenience kits due to missing rubber latex warning labels. Consumers with latex allergies face risk of allergic reaction if exposed to the unlabeled latex.

    Product
    Regard, T AND A - Rogers, sterilized convenience kits
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0475-2022·2022-01-19

    CT Scanner Software Update Causes Head Image Quality Degradation

    Siemens SOMATOM Definition Edge CT scanners with software version VB20_SP5 may produce degraded head images, increasing the risk of patient misdiagnosis. Devices have been distributed nationwide.

    Product
    SOMATOM Definition Edge -Computed tomography system Model 10590000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2022·2022-01-19

    CT Scanner Software Defect May Degrade Image Quality

    Software version VB20_SP5 in certain Siemens CT scanners may degrade head image quality, increasing misdiagnosis risk. The recall affects 794 units distributed nationwide.

    Product
    SOMATOM Definition AS-Computed tomography system Model 8098027
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0368-2022·2022-01-19

    Bosket Bread Baguettes Recalled for Undeclared Allergens

    Bosket Bread Company is recalling baguettes distributed in Washington due to missing ingredient statements on packaging. The products may contain undeclared wheat, milk, egg, soy, or sesame.

    Product
    Baguettes, Bosket Bread brand. The Net weight of the products range from 1-1.5 lbs. No UPC. Bread is packaged in food grade plastic bag with the black Bosket Bread logo sticker on the front, but without the ingredients statement affixed on a package.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0490-2022·2022-01-19

    Hip prosthetic stem undersized bore complicates removal surgery

    DePuy Orthopaedics' GLOBAL UNITE STD STEM prosthetics may have undersized spigot bores, complicating removal during revision surgery. Affected patients may experience surgical delays or bone damage.

    Product
    GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0487-2022·2022-01-19

    Orthopaedic Implant Stems Recalled for Undersized Spigot Bore Defect

    DePuy Orthopaedics is recalling GLOBAL UNITE REV STEM SZ 10 implants because the spigot bore may be undersized, preventing proper separation of components during revision surgery and potentially causing bone damage.

    Product
    GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0386-2022·2022-01-19

    Dream Pops Birthday Cake Bites Recalled for Undeclared Milk Allergen

    Dream Pops 100% Plant-Based Birthday Cake Bites are being recalled because they contain undeclared milk, a known allergen that poses a risk to people with milk allergies.

    Product
    100% Plant-Based Dream Pops Birthday Cake Bites UPC 854097008339
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0362-2022·2022-01-19

    Metoprolol Tartrate Tablets Recalled for Foreign Metal in Tablets

    Rubicon Research Private Limited is recalling Metoprolol Tartrate 25 mg tablets (batch #210211H1, expiration February 2024) due to a complaint of metal embedded in a tablet.

    Product
    METOPROLOL TARTRATE — METOPROLOL TARTRATE (METOPROLOL TARTRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0375-2022·2022-01-19

    Bosket Bread Brioche Dinner Rolls recalled for undeclared allergens

    Bosket Bread Company is recalling Brioche Dinner Rolls because the packages lack ingredient statements, leaving consumers unaware of potential allergen contents including wheat, milk, egg, soy, or sesame.

    Product
    Brioche Dinner Rolls, Bosket Bread brand. The Net weight of the products range from 1-1.5 lbs. No UPC. Product is packaged in food grade plastic bag with the black Bosket Bread logo sticker on the front, but without the ingredients statement affixed on a package.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0379-2022·2022-01-19

    Bosket Bread Olive Bread recalled for undeclared allergens

    Bosket Bread Company is recalling Olive Bread (Kalamata olives) products distributed in Washington because the packages lack ingredient statements, leaving wheat, milk, egg, soy, and sesame allergens undeclared.

    Product
    Olive Bread (Kalamata olives), Bosket Bread brand. The Net weight of the products range from 1-1.5 lbs. No UPC. Product is packaged in food grade plastic bag with the black Bosket Bread logo sticker on the front, but without the ingredients statement affixed on a package.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0390-2022·2022-01-19

    Local Fixe LLC Frozen Dinner Rolls Wheat Allergen Not Declared

    Local Fixe LLC is recalling frozen dinner rolls because wheat is not declared on the label, even though flour (which contains wheat) is listed as an ingredient. This poses a serious risk to consumers with wheat allergies.

    Product
    Dinner Rolls are shaped in rounds and sold frozen. Packaged in clear plastic Ziploc style plastic bags. The weight per package s 1.323 lbs/600 grams. The label is read in parts: "***Dinner rolls ***Flour, sourdough starter, water, egg, sugar, salt, grape seed oil, active dry y
    Category
    Food
    Distribution
    1 state
  • HighNHTSA·22V017000·2022-01-19

    Dennis Eagle Elite and Proview Recalled for Window Malfunction

    Dennis Eagle is recalling 2017-2021 Elite and Proview vehicles because windows may not open or close properly, potentially distracting drivers.

    Product
    DENNIS EAGLE — DENNIS EAGLE PROVIEW, ELITE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0471-2022·2022-01-19

    Philips Azurion X-ray System recalled for startup and emergency stop failures

    Philips recalls 10 Azurion interventional X-ray systems due to intermittent startup communication failures and emergency stop recovery issues that could prevent system restart and movement functionality.

    Product
    Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2 with LUC configuration start-up issue; Azurion R2.2 emergency stop recovery issue Model Numbers: 722221, 722228, 722225, 722068, 722226, 722078, 722224
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0393-2022·2022-01-19

    Squid Ink Fettuccine Pasta Recall: Undeclared Wheat Allergen

    Local Fixe LLC is recalling Squid Ink Fettuccine fresh pasta because wheat is not declared on the label, despite flour being an ingredient. The product poses a risk to consumers with wheat allergies.

    Product
    Squid Ink- Fettucine is raw fresh pasta portioned into 4 ounce portions. Each portion is rolled in a wax deli sheet and bulk packaged into a reusable plastic container with varying weight. Each container will have 40-60 portions, net wt. 10-15 lbs (4.536-6.804 kg). The label
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0371-2022·2022-01-19

    Bosket Bread Ciabatta Loaves Recalled for Undeclared Allergens

    Bosket Bread Company is recalling Ciabatta Loaves sold in Washington because the packages lack ingredient statements, leaving wheat, milk, egg, soy, and sesame undeclared. Consumers with allergies to these ingredients face a health risk.

    Product
    Ciabatta Loaves, Bosket Bread brand. The Net weight of the products range from 1-1.5 lbs. No UPC. Product is packaged in food grade plastic bag with the black Bosket Bread logo sticker on the front, but without the ingredients statement affixed on a package.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0442-2022·2022-01-19

    DRVN Nutraceuticals Inferno Fat Burner Blue Hawaii Contains Undeclared Milk

    DRVN Nutraceuticals Inferno Fat Burner Blue Hawaii 16oz jars contain undeclared milk and are being recalled. The FDA discovered the allergen during an investigation. Consumers with milk allergies or sensitivities should not consume this product.

    Product
    DRVN Nutraceuticals Inferno Fat Burner Blue Hawaii 16oz Jar UPC CODE
    Category
    Food
    Distribution
    26 states
  • HighFDA (Food)·F-0381-2022·2022-01-19

    Bosket Bread Sourdough Bread Lacks Required Ingredient Statement

    Bosket Bread Company is recalling sourdough bread products sold in Washington because packages are missing required ingredient statements, leaving consumers unable to identify potential allergens including wheat, milk, egg, soy, and sesame.

    Product
    Sourdough Bread, Bosket Bread brand. The Net weight of the products range from 1-1.5 lbs. No UPC. Product is packaged in food grade plastic bag with the black Bosket Bread logo sticker on the front, but without the ingredients statement affixed on a package.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0374-2022·2022-01-19

    Bosket Bread Country Loaf recalled for undeclared allergens

    Bosket Bread Company is recalling Country Loaf bread products distributed in Washington because packages lack ingredient statements, creating risk of undeclared wheat, milk, egg, soy, or sesame exposure.

    Product
    Country Loaf, Bosket Bread brand. The Net weight of the products range from 1-1.5 lbs. No UPC. Product is packaged in food grade plastic bag with the black Bosket Bread logo sticker on the front, but without the ingredients statement affixed on a package.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0391-2022·2022-01-19

    Classic Lasagna Pasta Sheets Recalled for Undeclared Wheat Allergen

    Local Fixe LLC is recalling Classic Lasagna Pasta sheets because the label declares flour as an ingredient but fails to declare wheat, which is present in the product. Consumers with wheat allergies may face serious health risks.

    Product
    Classic Lasagna Pasta sheets sold frozen and wrapped in brown freezer paper. The weight per package is 1 lb/453.6 grams. The label is read in parts: "***Classic Lasagna sheets *** Ingredients: Flour, Semolina, Egg, water ***www.localfixe.com***".
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0395-2022·2022-01-19

    Vemondo Vegan Dessert Cones Recalled for Undeclared Milk Allergen

    Lidl US Operations is recalling Vemondo Vegan Caramel & Pannacotta Non-Dairy Dessert Cones because they contain undeclared milk, posing a risk to consumers with milk allergies.

    Product
    Vemondo Vegan Caramel & Pannacotta Non-Dairy Dessert Cones. 4-3.7 fl oz (110 mL) UPC 4 056489 468653
    Category
    Food
    Distribution
    3 states
  • HighCPSC·22055·2022-01-19

    Children's Sleepwear Recalled for Flammability Standards Violation

    Childrensalon is recalling about 180 children's sleepwear garments that fail to meet U.S. flammability standards, posing a burn injury risk. Consumers should stop using the garments immediately and contact Childrensalon for return instructions.

    Product
    Children's Sleepwear Garments
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0480-2022·2022-01-19

    Rare Planet Health Ageless Tropical Island recalled for undeclared shellfish

    NutraCap Labs LLC is recalling Rare Planet Health Ageless Tropical Island (19oz bottles/jars, Lot #2005050, expiration 05/2022) because the product contains undeclared shellfish, which poses an allergen risk to consumers with shellfish allergies.

    Product
    Rare Planet Health Ageless Tropical Island Tropical Island 19oz UPC CODE
    Category
    Food
    Distribution
    26 states
  • HighFDA (Food)·F-0426-2022·2022-01-19

    DH Nutra Define Thermogenic Capsules Recalled for Undeclared Milk

    NutraCap Labs LLC is recalling DH Nutra Define Thermogenic Capsules because the product contains undeclared milk, a common allergen that poses a risk to consumers with milk allergies.

    Product
    DH Nutra Define Thermogenic Capsules 90ct Bottle UPC CODE
    Category
    Food
    Distribution
    26 states
  • HighFDA (Food)·F-0396-2022·2022-01-19

    Chili & Cheese Brat on Pretzel Bun Recalled for Undercooked Sausage

    Kitchen Fresh Foods is recalling Chili & Cheese Brat on Pretzel Bun products because the sausage was not fully cooked. The recall affects 1,069 pieces distributed across multiple states.

    Product
    Chili & Cheese Brat on Pretzel Bun, Item Number 1098, Net Wt. 6.5 oz(185g), UPC 7 47804-01098 8. Keep Refrigerated. Packaged under the following brands: 1. Grabn'Go, MFG BY: KF Foods, Green Bay, WI 54313; 2. Fox River Vending Inc. Dst By: Fox River Appleton WI, 54
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-0370-2022·2022-01-19

    Bosket Bread Rosemary Bread recalled for undeclared allergens

    Bosket Bread Company is recalling Rosemary Bread products sold in Washington due to missing ingredient statements, which fail to declare potential wheat, milk, egg, soy, or sesame allergens.

    Product
    Rosemary Bread, Bosket Bread brand. The Net weight of the products range from 1-1.5 lbs. No UPC. Product is packaged in food grade plastic bag with the black Bosket Bread logo sticker on the front, but without the ingredients statement affixed on a package.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0377-2022·2022-01-19

    Bosket Bread Hot Dog Buns Recalled for Undeclared Allergens

    Bosket Bread Company is recalling Hot Dog Buns distributed in Washington because the products lack ingredient statements on the package, leaving wheat, milk, egg, soy, and sesame allergens undeclared.

    Product
    Hot Dog Buns, Bosket Bread brand. The Net weight of the products range from 1-1.5 lbs. No UPC. Product is packaged in food grade plastic bag with the black Bosket Bread logo sticker on the front, but without the ingredients statement affixed on a package.
    Category
    Food
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0368-2022·2022-01-19

    Oxycodone Hydrochloride Oral Solution recalled for missing label

    Akorn, Inc. is recalling Oxycodone Hydrochloride Oral Solution 5 mg per 5 mL distributed nationwide due to missing label.

    Product
    Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0496-2022·2022-01-19

    Electri-Cool II Portable Cold Therapy Unit Recalled for Operating Instruction Labeling Update

    Gentherm Medical is recalling 484 Electri-Cool II cold therapy units (Model 767) distributed worldwide to provide updated labeling with revised operating instructions for Cold Therapy pads.

    Product
    Electri-Cool II Portable Cold Therapy Unit, Model Number 767, Part Number 86193
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0460-2022·2022-01-19

    Sufentanil Citrate Injection Recalled for Subpotency

    Akorn, Inc. is recalling Sufentanil Citrate Injection 100 mcg/2 mL due to subpotency—the drug was found to be out of specification for assay at the 30-month stability timepoint. Affected lot 031489A, with expiration 03/31/2022, was distributed nationwide.

    Product
    Sufentanil Citrate Injection, USP 100 mcg/2 mL (50 mcg/mL) for intravenous and epidural use, Rx only, 2 mL Ampule, Warning - May be habit forming, Preservative Free, Manufactured by Akorn, Inc. Lake Forest, IL 60045, NDC 17478-0050-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0364-2022·2022-01-19

    The Natural Dentist Mouthwash Label Mix-Up Recall

    The Natural Dentist Healthy Balance Peppermint Sage mouthwash (16.9 FL OZ, Lot 2091A) has been recalled due to a back label mix-up. The label incorrectly identifies the active ingredient as Menthol with the wrong UPC code instead of the correct Peppermint Oil and Sage Oil.

    Product
    The Natural Dentist Healthy Balance Peppermint Sage, Menthol 0.12%, 16.9 FL OZ (500 mL) bottles, Manufactured for Revive Personal Products Company, Madison, NJ 07940, UPC 7 14132 00071 4
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0365-2022·2022-01-19

    Carbamazepine tablets recalled for failed dissolution specifications

    Torrent Pharma Inc. is recalling Carbamazepine 200 mg tablets nationwide because they failed to meet dissolution specifications, which means the tablets may not release the medication properly in the body.

    Product
    CARBAMAZEPINE — CARBAMAZEPINE (CARBAMAZEPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0366-2022·2022-01-19

    Metformin 750 mg Extended Release Recalled for NDMA Contamination

    RemedyRepack Inc. is recalling Metformin 750 mg Extended Release (NDC # 70518-2920-00) due to detection of N-Nitrosodimethylamine (NDMA) levels exceeding the acceptable daily intake limit. The product was distributed to one direct account in Pennsylvania.

    Product
    Metformin 750 mg Extended Release NDC # 70518-2920-00
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0482-2022·2022-01-19

    Instavac Portable Suction Pumps Recalled for Premature Device Failures

    Ohio Medical Corporation is recalling Instavac Portable Suction Pumps (models 757000, 756000, and replacement pump part #AI5511) due to an increase in premature device failures. Affected units were distributed nationwide.

    Product
    Instavac Portable Suction Pump, Constant mode (model #757000, Instavac C) and Intermittent mode (model 756000, Instavac I); and Instavac replacement pumps, part #AI5511, a component of model numbers 756000 and 757000.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0367-2022·2022-01-19

    Morphine Sulfate Oral Solution 20 mg/mL recalled for missing label

    Akorn, Inc. is recalling Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) in 30 mL bottles nationwide due to missing labeling on approximately 10,836 bottles.

    Product
    Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0467-2022·2022-01-19

    Ki Mobility Little Wave Tyke Manual Contains Incorrect Instructions

    The Instructions for Use provided with Ki Mobility Little Wave Tyke contained instructions for a mechanical wheelchair instead of the caster-based design. Following incorrect instructions could lead to improper device operation.

    Product
    Ki Mobility, Little Wave Tyke (Weight Limit: 95 lbs), Specifically the IFU The Little Wave Tyke is a manually operated device that can be used for medical purposes and is used to assist a disabled person to move from one place to another while sitting. Intended to be used by per
    Category
    Medical Device
    Distribution
    8 states
  • HighNHTSA·22V016000·2022-01-18

    2022 Peterbilt 579 chassis step bolts may loosen and cause injury

    Bolts securing the chassis fairing step assembly on certain 2022 Peterbilt 579 vehicles may loosen and fracture. This can cause the step to move unexpectedly while entering or exiting the cab, increasing the risk of injury.

    Product
    PETERBILT — PETERBILT 579
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V015000·2022-01-17

    2022 Keystone Alpine RV Exterior Ladder May Detach from Rear Wall

    Keystone RV Company is recalling certain 2022 Alpine and Avalanche vehicles due to improperly secured exterior ladders that may detach while in use, creating a risk of injury.

    Product
    KEYSTONE — KEYSTONE ALPINE, AVALANCHE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22E002000·2022-01-14

    Tenneco Recalls Aftermarket Ball Joints for Toyota Sequoia and Tundra

    Tenneco Automotive is recalling aftermarket ball joints for 2004-2007 Toyota Sequoia and 2004-2006 Toyota Tundra vehicles due to potential premature failure.

    Product
    TOYOTA — TOYOTA SEQUOIA, TUNDRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V014000·2022-01-14

    KTM Recalls 2022 Husqvarna Motorcycles for Brake Pad Retaining Clip Defect

    KTM is recalling 2022 Husqvarna FE 350S and FE 501S motorcycles because incorrectly mounted front brake pad retaining clips may cause pads to detach, reducing braking performance.

    Product
    HUSQVARNA — HUSQVARNA FE 350S, FE 501S
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V013000·2022-01-14

    2021 Ford Diesel Trucks Fuel Filter Cap Defect Fire Risk

    Ford is recalling certain 2021 diesel trucks due to a void in the secondary fuel filter cap that may leak fuel, posing a fire risk. Dealers will replace the fuel filters free of charge.

    Product
    FORD — FORD F-350 SD, F-600 SD, F-450 SD, F-650
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V012000·2022-01-14

    2022 Forest River Cherokee toy hauler tires may be incorrectly specified on placard

    Forest River is recalling certain 2022 Cherokee toy haulers because the Tire and Loading Information placard may show incorrect rim specifications, potentially causing improper tire installation and crash risk.

    Product
    FOREST RIVER — FOREST RIVER CHEROKEE
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·22V011000·2022-01-13

    Ford Recalls Fusion, MKZ, and Mustang for Brake Pedal Bumper Defect

    Ford is recalling 2014-2015 Fusion, Lincoln MKZ, and 2015 Mustang vehicles because brake pedal bumpers may corrode and separate, potentially causing brake light confusion or rollaway risks.

    Product
    FORD — FORD, LINCOLN FUSION, MKZ, MUSTANG
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·22V010000·2022-01-13

    Seagrave Recalls 2011-2021 Firetrucks Due to Cracking Crossmember Plate

    Seagrave is recalling 2011-2021 Marauder and Capitol firetrucks because a crossmember mounting plate may crack, potentially distracting the driver and increasing crash risk.

    Product
    SEAGRAVE — SEAGRAVE CAPITAL, MARAUDER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • ModerateCPSC·22717·2022-01-13

    Textron E-Z-GO Freedom RXV Personal Transportation Vehicles Recalled Due to Fall Hazards

    Textron Specialized Vehicles is recalling about 280 E-Z-GO Freedom RXV personal transportation vehicles with rear-facing seats because the rear seat structure can fail and tilt unexpectedly, creating a fall and injury hazard. Consumers should stop using the rear-facing seat and contact Textron for a free repair.

    Product
    E-Z-GO Freedom RXV with Rear Facing Seat Personal Transportation Vehicles (PTV)
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0363-2022·2022-01-12

    Nature's Own Honey Wheat Bread recalled for undeclared milk

    Flowers Foods is recalling Nature's Own Honey Wheat Bread due to undeclared milk, which poses a risk to consumers with milk allergies. The product was distributed in Arizona, California, Colorado, New Mexico, Nevada, and Wyoming.

    Product
    Nature's Own Honey Wheat Bread, NET WT 20 oz (1LB 4 OZ) 567g, DISTRIBUTED BY FLOWERS BAKERIES, LLC THOMASVILLE, GA 31757 Single loaf UPC 0 72250 03706 8 & Double pack UPC 0 72250 00539 5
    Category
    Food
    Distribution
    6 states
  • SevereFDA (Food)·F-0362-2022·2022-01-12

    Godavari Brand Apricots Recalled for Undeclared Sulfites

    Bokhary Foods, Inc. is recalling Godavari brand apricots in 7 oz and 14 oz packages because they contain undeclared sulfites. Consumers allergic or sensitive to sulfites should not consume the product.

    Product
    GODAVARI brand APRICOTS, packaged in 7 oz (UPC 0 03658 50001 4) and 14 oz (UPC 0 03657 5001 5) clear plastic-film bags with the GODAVARI brand label on the front. Each bag is filled with orange-colored dried apricots that can be seen through the bag.
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0457-2022·2022-01-12

    Medical Device Kit Poses Risk of Sample Leakage and Lab Contamination

    DiaSorin Molecular's Simplexa Direct Amplification Disc Kit is recalled due to risk of leakage when used multiple times, which may cause cross-contamination in laboratory settings if not properly cleaned.

    Product
    Simplexa Direct Amplification Disc Kit, Product Kit Code MOL1455
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-0447-2022·2022-01-12

    Invacare AVIVA Storm RX Power Wheelchairs Recalled for Firmware Deceleration Malfunction

    Invacare AVIVA Storm RX power wheelchairs with firmware version 6.1.2 may decelerate more aggressively than programmed, risking user injury.

    Product
    Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: SRX-20R, SRX-20SP, SRX-20MP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0456-2022·2022-01-12

    Hemodialysis Delivery System distributed without FDA premarket approval

    The DBB-06 Hemodialysis Delivery System was distributed without required FDA premarket approval. Approximately 781 units were shipped to healthcare facilities in multiple states.

    Product
    DBB-06 Hemodialysis Delivery System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0463-2022·2022-01-12

    Abbott Alinity m System camera firmware installation issue

    Abbott Molecular is recalling 74 Alinity m Systems due to an issue with the installation of updated camera firmware. Affected devices were distributed in the United States and internationally.

    Product
    Alinity m System, Part No. 08N53-002
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0445-2022·2022-01-12

    Power wheelchairs with LiNX Gyro module recalled for deceleration control failure

    Invacare power wheelchairs with LiNX Gyro firmware 6.1.2 may decelerate more aggressively than programmed, risking user injury due to an incorrect deceleration profile.

    Product
    Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: TDX SP2: TDXSP2, TDXSP2-CG, TDXSP2X-CG, TDXSP2-MCG, TDXSP2X-MCG, TDXSP2V, TDXSP2V-HD, TDXSP2HD, TDXSP2HD-CG, TDXSP2HD-MCG
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0462-2022·2022-01-12

    Alinity m System recalled for software defect in amplification detection

    Abbott Molecular is recalling 742 Alinity m Systems worldwide due to a software defect that can set the Amplification Detection clamp CLEAN position too high, potentially affecting instrument operation.

    Product
    Alinity m System, Part No. 08N53-002
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0461-2022·2022-01-12

    Alinity m System Software Issue Affects Maintenance and Diagnostics Procedures

    Abbott Molecular is recalling 742 Alinity m System units worldwide due to a software issue that prevents Field Service Engineers from properly completing maintenance and diagnostics procedures.

    Product
    Alinity m System, Part No. 08N53-002
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0458-2022·2022-01-12

    UROMEDICA Implantation Instrument Sheath May Damage ProACT Implants

    Uromedica is recalling nonsterile implantation instrument sheaths (Lot UM00794 and UM00817) because the U-channel sheaths may damage ProACT implant devices during implantation procedures. Affected devices were distributed nationwide.

    Product
    UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0455-2022·2022-01-12

    COVID-19 Diagnostic Kit Recall for Inaccurate Test Results

    Qiagen Sciences is recalling 376 units of its QIAstat-Dx Respiratory SARS-CoV-2 Panel diagnostic kit due to faulty cartridges that can produce false-negative or false-positive test results.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0448-2022·2022-01-12

    Orthopedic Inserter Shaft Recalled for Mating Incompatibility During Surgery

    Flower Orthopedics is recalling 48 units of the Flex-Thread Inserter Shaft due to mating incompatibility with the Inserter Draw Rod. The defect may cause the draw rod to bind during fibula intramedullary nail insertion, potentially preventing surgery completion.

    Product
    Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0449-2022·2022-01-12

    Clinical Chemistry Analyzer Software Flaw May Cause Inaccurate Test Results

    Siemens is recalling Atellica CH 930 clinical chemistry analyzers with software v1.25.1 or lower. Two software defects could cause inaccurate test results: test parameters may revert to defaults, or the analyzer may use expired reagents.

    Product
    Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. Siemens Material Number (SMN): 11067000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·22051·2022-01-12

    2021 Giant and Liv Adult Bicycles Recalled for Loose Handlebar Stem

    Giant Bicycle Inc. is recalling about 20,800 units of 2021 Model Year Giant and Liv adult bicycles because the adjustable handlebar stem can become loose, posing fall and injury hazards. The company has received 86 reports of loose handlebars, including three reports of riders falling.

    Product
    2021 Model Year Giant and Liv Adult Bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0446-2022·2022-01-12

    Invacare AVIVA FX power wheelchair LiNX Gyro deceleration malfunction

    Some Invacare AVIVA FX power wheelchairs with LiNX Gyro firmware 6.1.2 may decelerate more aggressively than programmed, creating injury risk.

    Product
    Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A and DLX-GRY101-A) Models: IFX-20R, IFX-20SP, IFX-20MP, IFX-20C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0503-2022·2022-01-12

    Macaroni & Cheese Recalled Due to Undeclared Egg Allergen

    Sandridge Food Corporation is recalling Macaroni & Cheese (Macarrones con Queso) distributed to restaurants and a hotel in Texas because the product contains egg but does not declare this allergen on the label.

    Product
    Macaroni & Cheese, Macarrones con Queso; 3-5 lb pouches/bolsas, NET WT/PESO NETO 240 OZ (15 LB) 6.80 kg; distributed by Gordon Food Service, Reorder No. 540061, Vendor Item # 4357505, Perishable. Keep Refrigerated. Perecedero. Mantener Refrigerado.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0464-2022·2022-01-12

    Medtronic Abre Venous Stent System recalled for reports of stent migration

    Medtronic is recalling the Abre Venous Self-Expanding Stent System due to reports of stent migration. Approximately 21,653 devices were distributed nationwide and internationally.

    Product
    Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0453-2022·2022-01-12

    Medshape DYNANAIL MINI surgical nail recalled for improper endcap length

    Medshape is recalling DYNANAIL MINI surgical nails due to manufacturing defect in lot 04882. Affected endcaps may not seat flush during surgical insertion, potentially affecting implant integrity.

    Product
    DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile
    Category
    Medical Device
    Distribution
    9 states

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