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 13731

  • 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-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-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-0520-2023·2022-12-21

    Medical procedure trays recalled for incomplete outer bag sealing

    Stradis Medical recalls Henry Schein temp stimulator supplies due to incomplete outer bag sealing that may compromise kit sterility. Affected units should not be used until reviewed.

    Product
    HENRY SCHEIN, TEMP STIMULATOR SUPPLIES, Item No.570-2883
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0626-2023·2022-12-21

    DeRoyal TLIF Procedure Packs Recalled Due to Included 3M Steri Drapes

    DeRoyal TLIF procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The affected packs were distributed across multiple U.S. states.

    Product
    DeRoyal TLIF PACK, REF 89-8780.04
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0543-2023·2022-12-21

    Surgical procedure trays recalled for incomplete outer-bag sealing

    Stradis Healthcare is recalling surgical procedure trays and kits due to manufacturing defects that may result in incomplete sealing of the outer bag, potentially compromising sterility. Affected products were distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Vein, Item No.682-1732,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0485-2023·2022-12-21

    Stradis Healthcare Surgical Pack Recall for Compromised Sterility

    Stradis Healthcare is recalling surgical kits because the outer bag may be incompletely sealed, potentially compromising the sterility of the product.

    Product
    STRADIS HEALTHCARE, Surg Pack, Item No.40450SMS, dental
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0517-2023·2022-12-21

    Henry Schein Universal Tray Recall for Incomplete Sealing

    Stradis Medical recalls 675 Henry Schein Universal Trays due to incomplete outer bag sealing that may compromise sterility. The defect affects surgical procedures nationwide and in Canada.

    Product
    HENRY SCHEIN, UNIVERSAL TRAY, Item No.570-2787
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-0541-2023·2022-12-21

    Surgical procedure kits recalled for incomplete seal and potential sterility breach

    Stradis Healthcare is recalling medical surgical procedure trays and kits with potentially incomplete outer bag seals that could compromise sterility. These products were distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Vasc Vein, Item No.682-1583,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0512-2023·2022-12-21

    Medical and Surgical Procedure Trays Recalled for Incomplete Seal

    Stradis Medical recalled Henry Schein Basic Pack medical and surgical procedure trays due to manufacturing defects causing incomplete outer bag seals that may compromise sterility. The affected kits were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, BASIC PACK, Item No.570-2719, UDI/DI (case) H65857027191, UDI/DI (kit)M75257027190, Serial/Lot Numbers: 22242489505
    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-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-0472-2023·2022-12-21

    Linear accelerator software addresses potential wrong-site treatment risk

    Siemens linear accelerator systems may allow users to select the wrong treatment site, potentially delivering radiation to the wrong location. The FDA classified this Class II recall affecting 8 units across seven U.S. states.

    Product
    ARTISTE, ONCOR and PRIMUS with syngo RT Therapist with software version 4.3.1 MR3. Material Number: 8162815 Intended Use: Family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0487-2023·2022-12-21

    Oral Surgery Trays Recalled for Incomplete Sealing of Sterility Bags

    Stradis Healthcare is recalling certain oral surgery trays because the outer packaging may be incompletely sealed, potentially compromising the sterility of the surgical instruments.

    Product
    STRADIS HEALTHCARE, Surg, Item No.40551TMS. oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0553-2023·2022-12-21

    STRADIS HEALTHCARE Surgical Procedure Trays Recalled for Incomplete Sterile Sealing

    STRADIS HEALTHCARE surgical procedure trays and kits are being recalled due to a manufacturing condition that may result in incomplete sealing of the outer bag, potentially compromising kit sterility.

    Product
    STRADIS HEALTHCARE, Femoral, Vasc, Item No.686-142,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0497-2023·2022-12-21

    Dental Surgical Pack Recalled Due to Incomplete Sterile Seal

    Stradis Medical is recalling a dental surgical pack because the outer bag may be incompletely sealed, potentially compromising sterility. Affected units should not be used.

    Product
    Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2023·2022-12-21

    Medical Device Recall: DeRoyal CNRV Peripheral VAS Pack

    DeRoyal Industries is recalling 68 kits of the CNRV Peripheral VAS Pack. The voluntary Class II recall affects healthcare facilities in 23 US states with specific lot numbers.

    Product
    DeRoyal CNRV PERIPHERAL VAS PACK, REF 89-10530.03
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0494-2023·2022-12-21

    Surgical Implant Trays Recalled for Incomplete Package Seal

    Stradis Healthcare is recalling 162 surgical implant trays distributed nationwide due to incomplete outer bag seals that may compromise sterility.

    Product
    Surgical room, Implant Pack, Item No.41111UTI, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0499-2023·2022-12-21

    Stradis Healthcare Safety Pins Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling 1-inch safety pins due to manufacturing defects that may result in incomplete sealing of outer bags, potentially compromising the sterility of medical and surgical procedure kits.

    Product
    STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0609-2023·2022-12-21

    DeRoyal HEART PACK procedure kits recalled for defective component

    DeRoyal Industries is recalling 102 HEART PACK procedure kits (Lot 57367401, expiration 3/1/2025) distributed across 23 U.S. states because they contain recalled 3M Health Care Steri Drapes.

    Product
    DeRoyal HEART PACK, REF 89-8351.12
    Category
    Medical Device
    Distribution
    0 states