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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10351–10375 of 13717

  • HighFDA (Devices)·Z-0524-2023·2022-12-21

    Stradis Healthcare Surgical Knee Packs Recalled for Incomplete Sealing

    HENRY SCHEIN Knee Packs are being recalled due to incomplete outer bag sealing that may breach sterility. Affected surgical kits were distributed in the US and Canada.

    Product
    HENRY SCHEIN, Knee Pack, Item No.570-2908,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0662-2023·2022-12-21

    FDA Class II Recall: DeRoyal BIOPSY PACK Medical Device

    DeRoyal Industries has recalled 480 units of its BIOPSY PACK (REF 89-9614.07) in a voluntary, firm-initiated recall affecting 23 US states. The specific reason for the recall has not been disclosed.

    Product
    DeRoyal BIOPSY PACK, REF 89-9614.07
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0479-2023·2022-12-21

    Medical cot may experience unintended motion due to cable damage

    Stryker's Power-PRO 2 surgical cot may lower unexpectedly due to damaged cables, risking soft tissue injuries to patients. The recall affects 465 units distributed in the US and internationally.

    Product
    Power-PRO 2, Model No. 6507, Item No. 650705550001 (US); 650700000000 (International)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0581-2023·2022-12-21

    DeRoyal Cannulated Hip Packs Recalled for Defective Steri Drapes

    DeRoyal Industries is recalling 108 kits of Cannulated Hip Procedure Packs because they contain 3M Steri Drapes that have been recalled. Affected lots were distributed across 23 U.S. states.

    Product
    DeRoyal CANNULTED HIP PACK CSM, REF 89-6977.09
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0456-2023·2022-12-21

    Intra-Aortic Balloon Pump Recalled for Potential Battery Run-Time Issue

    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump devices are being recalled worldwide due to a potential issue with short battery run-times. Healthcare providers and patients should contact the manufacturer for guidance.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0720-2023·2022-12-21

    Cordis Angiographic Catheter Extensions Recalled for Male Connector Separation Risk

    Cordis angiographic catheter extensions may experience separation at the male connector during use. Approximately 2,915 US units were distributed; users should verify affected lot numbers.

    Product
    Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0471-2023·2022-12-21

    Knee implant tibial component recalled for higher revision rates

    Zimmer Biomet is voluntarily recalling 284 NexGen tibial knee components due to higher revision rates when paired with specific femoral components. Patients with these implant combinations should contact their surgeon.

    Product
    NexGen Option Stemmed Tibial Component Size 8, Item Number 00-5986-057-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0646-2023·2022-12-21

    DeRoyal TOTAL HIP PACK medical device recall, 85 kits

    DeRoyal Industries Inc is recalling 85 kits of its TOTAL HIP PACK surgical device (Ref 89-9301.07). The reason for recall was not disclosed. The recall affects 22 US states with two specific lot numbers.

    Product
    DeRoyal TOTAL HIP PACK, REF 89-9301.07
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0522-2023·2022-12-21

    Surgical Procedure Trays Recalled for Incomplete Sterile Barrier Sealing

    Stradis Medical recalls Henry Schein surgical procedure trays due to incomplete outer bag sealing that may compromise sterility. No injuries reported.

    Product
    HENRY SCHEIN, LOOP RECORDER PACK, Item No.570-2891
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0610-2023·2022-12-21

    FDA Recalls DeRoyal HEART PACK Medical Device Kits

    FDA is recalling 51 DeRoyal HEART PACK medical device kits (Lot 57893436) distributed across 23 US states. The specific reason for this Class II recall has not been disclosed.

    Product
    DeRoyal HEART PACK, REF 89-8351.13
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0506-2023·2022-12-21

    General Surgery Procedure Kit Recalled for Sterility Concerns

    Stradis Medical is recalling surgical procedure kits with potentially incomplete outer bag seals that may compromise sterility. The recall affects 35 units distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, PROCEDURE KIT, Item No.570-1508, general surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0560-2023·2022-12-21

    DeRoyal Minor Oral and ENT Procedure Packs Recalled for Defective Steri Drapes

    DeRoyal procedure packs distributed across multiple U.S. states are being recalled because they contain previously recalled 3M Steri Drapes. Affected healthcare facilities should stop using the packs and contact the manufacturer.

    Product
    DeRoyal MINOR ORAL / ENT PACK, REF 89-2576.15
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0690-2023·2022-12-21

    FDA Recalls DeRoyal CNRV Spinal Pack Medical Devices

    DeRoyal has voluntarily recalled 69 kits of CNRV Spinal Pack medical devices distributed to 23 US states. The manufacturer initiated the recall on November 3, 2022.

    Product
    DeRoyal CNRV SPINAL PACK, REF 89-10532.03
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0700-2023·2022-12-21

    DeRoyal medical device anesthesia pack Class II recall across 23 states

    DeRoyal Industries voluntarily initiated a Class II recall of 170 GEO-MED local anesthesia packs distributed across 23 US states. The specific safety concern is not detailed in the recall notice.

    Product
    GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0551-2023·2022-12-21

    Medical Surgical Trays: Incomplete Outer Bag Sealing May Breach Sterility

    Stradis Medical is recalling surgical procedure trays due to incomplete sealing of the outer bag, which may compromise the sterility of the kit.

    Product
    STRADIS HEALTHCARE, Vein, Item No.682-577,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0539-2023·2022-12-21

    Stradis Ablation Pack Recalled for Potentially Compromised Sterile Seal

    Stradis Healthcare is recalling Ablation Pack Item No. 682-130 due to incomplete outer bag seals that may compromise sterility. The defect may allow contamination of surgical kits.

    Product
    STRADIS HEALTHCARE, Ablation Pack, Item No.682-130,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0645-2023·2022-12-21

    Medical Device Recall: DeRoyal TOTAL KNEE PACK surgical kit

    DeRoyal Industries recalled 48 kits of the TOTAL KNEE PACK surgical product in November 2022. The specific reason for the recall was not disclosed in the public notice.

    Product
    DeRoyal TOTAL KNEE PACK, REF 89-9300.08
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0523-2023·2022-12-21

    Procedure Trays Recalled for Potential Sterility Breach Due to Incomplete Sealing

    Stradis Medical recalls Henry Schein procedure trays because the outer bag may be incompletely sealed, risking sterility breach. The trays were distributed nationwide and in Canada.

    Product
    HENRY SCHEIN, PROCEDURE TRAY, Item No.570-2900,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2023·2022-12-21

    Surgical procedure trays with incomplete outer bag seals recalled

    Stradis Healthcare is recalling Henry Schein labiaplasty procedure kits due to incomplete outer bag seals that could compromise sterility. The 42-unit recall affects products distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, Labiaplasty PackItem No.570-3118,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2023·2022-12-21

    Stradis Healthcare catheter angiography kits recalled for defective sterile sealing

    Stradis Medical is recalling catheter angiography procedure kits with potentially incompletely sealed outer bags that may compromise the sterile integrity of the medical devices.

    Product
    HENRY SCHEIN, CATH ANGIO PACK, Item No.570-2930
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0635-2023·2022-12-21

    DeRoyal hip surgical pack recalled in voluntary Class II action

    DeRoyal Industries is recalling 8 kits of its TOTAL HIP PACK (Lot 57460930) distributed across 23 U.S. states in a voluntary Class II FDA recall.

    Product
    DeRoyal TOTAL HIP PACK, REF 89-9113.07
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0580-2023·2022-12-21

    DeRoyal Cataract Procedure Packs Recalled Due to Defective Sterile Drapes

    DeRoyal Industries is recalling approximately 1,220 cataract procedure packs that contain recalled 3M Health Care Steri Drapes. The affected kits were distributed to healthcare facilities across 23 U.S. states.

    Product
    DeRoyal CATARACT PACK CSM, REF 89-6863
    Category
    Medical Device
    Distribution
    0 states