The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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19551–19575 of 27461

  • HighFDA (Devices)·Z-1030-2023·2023-02-08

    Non-sterile procedural trays risk sterile packaging breach

    Medline Industries is recalling non-sterile laparoscopic procedural trays containing sterile blades that may puncture the outer packaging, potentially breaching the sterile barrier. 260 cases have been distributed nationwide.

    Product
    Non-sterile procedural trays labeled as LAPAROSCOPIC, 2 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1047-2023·2023-02-08

    Medline UNITE Foot & Ankle Drill Bit Recalled for Intra-operative Screw Failure Risk

    Medline Industries recalls 190 UNITE foot and ankle drill bits due to observed screw failure during surgery. When used to pre-drill holes for certain screw sizes, the drill bits may fail under surgical torque, creating risk during procedures.

    Product
    MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0262-2023·2023-02-08

    Diltiazem Hydrochloride extended-release capsules recalled due to failed quality specifications

    Sun Pharmaceutical is recalling Diltiazem Hydrochloride Extended-Release Capsules (360 mg) due to failed impurity specifications and dissolution testing found during FDA laboratory evaluation. The recall affects five lot numbers distributed nationwide.

    Product
    DILTIAZEM HYDROCHLORIDE — DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1022-2023·2023-02-08

    SynCardia Total Artificial Heart System Recalled for Cannula Tears

    SynCardia Systems is recalling its Total Artificial Heart System due to reported tears in the cannula caused by wear and tear stress. Approximately 1,732 systems worldwide are affected.

    Product
    SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2023·2023-02-08

    Turbett Surgical Container TS1000 may have weld failures breaching sterile barrier

    Turbett Surgical Container TS1000 may have weld failures that breach the sterile barrier, potentially resulting in unsterile instruments being used in medical procedures and risking patient infection or injury.

    Product
    Turbett Surgical Container, TS1000: Indicated for enclosing other medical devices that are to be sterilized by a healthcare provider
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2023·2023-02-08

    Siemens Fluoroscopic X-ray Systems Risk of Boot Failure After Shutdown

    Certain Siemens fluoroscopic X-ray systems may only boot into backup mode after an abrupt shutdown, preventing full operation. This could necessitate cancelling or switching to alternative treatment systems.

    Product
    System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 108
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0325-2023·2023-02-08

    Frozen Breakfast Burritos Recalled for Undeclared Milk Allergen

    The Miso Brothers is recalling Alpha Plant Based Breakfast Burritos because they contain undeclared milk. This poses a risk to consumers with milk allergies or sensitivities.

    Product
    Alpha Plant Based Breakfast Burrito - BAC'N SCRAMBLE 5.5 oz. UPC 855099007948 Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1036-2023·2023-02-08

    OSS Modular Arthrodesis Nail Recalled for Missing Locking Bolts

    Biomet is recalling certain OSS Modular Arthrodesis Nails due to missing locking bolts that could require extended surgery. Affected units are Lot 136620.

    Product
    OSS Modular Arthrodesis Nail, 7 Degree Collar Assembly with Locking Bolts-For use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee Item Number: CP260602
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1035-2023·2023-02-08

    Non-sterile procedural knee trays recalled for potential packaging breach

    Medline Industries recalls non-sterile Total Knee procedural trays because sterile blades inside can puncture the outer foil packaging. This could compromise sterile blade integrity.

    Product
    Non-sterile procedural trays labeled as TOTAL KNEE KIT, 1 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1033-2023·2023-02-08

    Non-sterile orthopedic procedural trays recalled for potential sterile packaging breach

    Medline Industries recalls non-sterile orthopedic procedural trays that may contain sterile blades capable of puncturing the protective foil packaging, compromising sterile barriers.

    Product
    Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1034-2023·2023-02-08

    Procedural Trays with Sterile Blades May Have Damaged Packaging

    Medline Industries is recalling 45 units of procedural trays containing sterile surgical blades. The sharp blades may puncture the outer sterile packaging, potentially compromising sterility and increasing infection risk.

    Product
    Non-sterile procedural trays labeled as THEDA CLARK TOTAL KNEE CDS, 1 per case
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0333-2023·2023-02-08

    Ameripack Foods Chocolate Brownies Recalled for Undeclared Soy and Egg

    Ameripack Foods LLC is recalling Chocolate Chunk Brownies (UPC 4122077413) due to undeclared soy and egg allergens. Consumers with allergies to these ingredients should not consume the product.

    Product
    Chocolate Chunk Brownie 13oz UPC 4122077413 packaged in a metal tray with a clear plastic nonflexible lid, 6 trays per case
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1026-2023·2023-02-08

    Affinity Fusion Oxygenator adapter may loosen during cardiac surgery

    Medtronic is recalling Affinity Fusion Oxygenators because the Temperature Monitoring Adapter may come loose during setup or disassembly of the heart-lung machine used in cardiac surgery. No injuries have been reported.

    Product
    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0331-2023·2023-02-08

    Frozen burritos recalled for undeclared milk allergen

    THE MISO BROTHERS INC is recalling Alpha Plant-Based Burrito (Pizza, 5.5 oz) because the product contains undeclared milk. Consumers with milk allergies should not consume this product.

    Product
    Alpha Plant-Based Burrito - Pizza 5.5 oz UPC 855099007016 Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1045-2023·2023-02-08

    MEDLINE UNITE Foot and Ankle Screw Recall: Intra-Operative Failure

    MEDLINE INDUSTRIES is recalling 420 units of UNITE Foot and Ankle surgical screws (Lot 810304) due to observed intra-operative failure when pre-drilled and implanted with excessive torque.

    Product
    MEDLINE UNITE FOOT & ANKLE Screw, Non-Locking, Mini T8 (2.0x8mm), REF MMSN2008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1024-2023·2023-02-08

    Affinity Fusion Oxygenator temperature monitoring adapter may loosen during cardiac surgery

    The temperature monitoring adapter on Medtronic's Affinity Fusion Oxygenator may come loose during cardiopulmonary bypass procedures. The manufacturer has received multiple complaints about this issue.

    Product
    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0335-2023·2023-02-08

    Ube Ensaymada recalled for undeclared wheat allergen

    Joy Joys Bakery LLC is recalling Ube Ensaymada sold in Washington and Oregon due to undeclared wheat. The product label lists flour but does not specify wheat flour.

    Product
    Ube Ensaymada, UPC 6658266481. Product is packaged in plastic clear clamshell container and there are 4 pieces per container. Ingredients: Cream Cheese, Cheese, Butter, Milk, Sugar, Salt, Water, Yeast, Flour, Egg. Joy Joy s Bakery contact information: (253) 507-5259, 11107 Pacifi
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0318-2023·2023-02-08

    DR SNACK Crystal Ginger recalled for undeclared sulfites

    DR SNACK Crystal Ginger was recalled because the product contains undeclared sulfites. Affected products were distributed in the Northeast U.S.

    Product
    DR SNACK brand Crystal Ginger; Net Wt. 7.00 oz (0.20kg); Net 6oz; and Net 10 oz.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Devices)·Z-1042-2023·2023-02-08

    Vanguard Knee System Prosthesis Components Incorrectly Labeled for Size and Side

    Biomet is recalling 157 units of Vanguard Knee System prosthesis components incorrectly labeled as different sizes or surgical sides. Surgeons relying on labels could implant the wrong size or side, requiring corrective surgery.

    Product
    (1) Vanguard Knee System PS Open Box Femoral; Right; 60 mm. Intended for knee joint replacement prostheses. Item Number: 183104 (2) Vanguard Knee System PS Open Box Femoral; Right; 62.5 mm Item Number: 183106 (3) Vanguard Knee System PS Open Box Femoral; Right; 65 mm Item Num
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Food)·F-0336-2023·2023-02-08

    Ube Roll bakery product recall due to undeclared wheat allergen

    Joy Joys Bakery is recalling Ube Roll packages because the label lists 'flour' but does not specify it is wheat flour, creating an allergen risk for consumers with wheat sensitivity.

    Product
    Ube Roll UPC 35961092. Product is packaged in plastic clear clamshell container and there are 3 pieces per container. Ingredients: Ube Flavoring, Butter, Flour, Sugar, Salt, Yeast, Egg, Milk, Water. Joy Joy s Bakery contact information: (253) 507-5259, 11107 Pacific HWY SW Lake
    Category
    Food
    Distribution
    2 states
  • HighFDA (Food)·F-0330-2023·2023-02-08

    Alpha Plant-Based Burrito Recall: Undeclared Milk Allergen

    THE MISO BROTHERS INC is recalling Alpha Plant-Based Burritos because they contain undeclared milk, a common allergen. Approximately 31,092 units are affected across US retail locations.

    Product
    Alpha Plant-Based Burrito - Philly 5.5 oz UPC 855099007023 Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Food)·F-0334-2023·2023-02-08

    Ube Spanish Bread Recalled Due to Undeclared Wheat Allergen

    Joy Joys Bakery LLC recalls Ube Spanish Bread because the label lists 'flour' without specifying it is wheat flour, failing to disclose a major allergen. The product was distributed in Washington and Oregon.

    Product
    Ube Spanish Bread, UPC 36897113. Product is packaged in plastic clear clamshell container and there are 6 pieces per container. Ingredients: Ube Flavoring, Butter, Egg, Flour, Water, Milk, Sugar, Salt, Yeast. Joy Joy s Bakery contact information: (253) 507-5259, 11107 Pacific HW
    Category
    Food
    Distribution
    2 states
  • HighFDA (Devices)·Z-1023-2023·2023-02-08

    Medtronic Affinity Fusion Oxygenator: Temperature Monitoring Adapter May Detach

    Medtronic is recalling 2,937 Affinity Fusion Oxygenators used in cardiac surgery because the Temperature Monitoring Adapter may detach during setup or disassembly.

    Product
    Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0327-2023·2023-02-08

    Frozen breakfast sandwiches and burritos recalled for undeclared milk allergen

    The Miso Brothers Inc. is recalling frozen breakfast sandwiches and breakfast burritos containing undeclared milk, affecting approximately 31,092 units distributed throughout US retail locations. This poses a risk to consumers with milk allergies.

    Product
    Alpha Plant-Based Breakfast Sandwich - Meatless Sausage, Plant-Based Egg & Cheeze 5 oz. UPC 810070350093 Frozen
    Category
    Food
    Distribution
    0 states
  • HighFDA (Devices)·Z-1028-2023·2023-02-08

    Medtronic Perfusion Oxygenator Temperature Monitoring Adapter Detachment Recall

    Medtronic has recalled Custom Pack Perfusion Tubing Packs used in cardiopulmonary bypass procedures. The Temperature Monitoring Adapter on the oxygenator may detach during setup or disassembly.

    Product
    Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
    Category
    Medical Device
    Distribution
    Distributed nationwide