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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10501–10525 of 13816

  • HighFDA (Devices)·Z-0519-2023·2022-12-21

    Henry Schein Pacemaker Surgical Kits Recalled for Sterility Concerns

    Surgical procedure kits supplied by Henry Schein may have incompletely sealed outer bags, potentially compromising sterility. Affected units should not be used.

    Product
    HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0711-2023·2022-12-21

    DeRoyal surgical cataract pack subject to Class II recall

    DeRoyal Industries voluntarily recalled 530 cataract surgical packs (Lot 57755800) classified as FDA Class II. The recall affects multiple U.S. states.

    Product
    DeRoyal CATARACT PACK, REF 89-8859.08
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0677-2023·2022-12-21

    FDA recalls DeRoyal CRANI PACK medical device over defect

    The FDA has recalled DeRoyal CRANI PACK devices (Lot 57389117, expiring 9/1/2026) due to a device defect. The recall affects 16 kits distributed across 23 US states.

    Product
    DeRoyal CRANI PACK, REF 89-10202.05
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0544-2023·2022-12-21

    Angioplasty Procedure Trays Recalled Due to Incomplete Bag Sealing

    Stradis Healthcare angioplasty procedure trays may have incompletely sealed outer bags, risking sterility compromise. Affected units should not be used pending further instructions.

    Product
    STRADIS HEALTHCARE, Angioplasty, Item No.682-1937,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0556-2023·2022-12-21

    Surgical Procedure Trays Recalled Over Incomplete Outer Bag Seals

    Stradis Medical is recalling surgical procedure trays due to manufacturing defects that may leave outer bags incompletely sealed, potentially breaching kit sterility. No illnesses have been reported.

    Product
    HENRY SCHEIN, Vas Pack, Item No.888-2520,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0509-2023·2022-12-21

    Surgical Procedure Kits Recalled for Potential Sterility Seal Defect

    Stradis Medical is recalling Henry Schein breast procedure kits distributed nationwide in the US and Canada due to incomplete outer bag sealing that may compromise sterility. No illnesses reported.

    Product
    HENRY SCHEIN, BREAST PACK, Item No.570-2397
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2023·2022-12-21

    FDA recalls Henry Schein bone marrow kit for defective seal

    Henry Schein bone marrow kits may have incompletely sealed outer bags, compromising sterility. Affected units were distributed in the US and Canada.

    Product
    HENRY SCHEIN, BONE MARROW KIT, Item No.570-3092
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0557-2023·2022-12-21

    Henry Schein Vas Reversal Pack Surgical Kit Recalled for Incomplete Seal

    A surgical procedure kit is being recalled due to manufacturing conditions that may result in an incompletely sealed outer bag, potentially compromising sterility. Affected kits were distributed in the US and Canada.

    Product
    HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0554-2023·2022-12-21

    Angio Pack surgical trays recalled for incomplete sealing and sterility breach

    Stradis Healthcare is recalling Angio Pack surgical trays due to manufacturing defects that may leave the outer bag incompletely sealed, compromising product sterility. Affected units were distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Angio Pack, Item No.686-199,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0561-2023·2022-12-21

    DeRoyal Oral Procedure Packs Recalled for Affected Steri Drapes

    DeRoyal Industries is recalling MAJOR ORAL PACK RF kits containing recalled 3M Health Care Steri Drapes. The affected lots were distributed to healthcare facilities in 23 US states.

    Product
    DeRoyal MAJOR ORAL PACK RF, REF 89-3936.15
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0466-2023·2022-12-21

    NexGen Stemmed Tibial Component Recalled Due to Higher Revision Rates

    Zimmer is recalling NexGen Option Stemmed Tibial Components due to higher revision rates when used with certain femoral components in knee replacements.

    Product
    NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0546-2023·2022-12-21

    Stradis Healthcare Venous Access Pack Recalled for Potential Sterility Breach

    Stradis Medical is recalling Venous Access Packs because the outer bag may be incompletely sealed, potentially compromising the sterility of the kit. Affected units were distributed in the US and Canada.

    Product
    STRADIS HEALTHCARE, VENOUS ACCESS PACK, Item No.682-1993R1,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0603-2023·2022-12-21

    DeRoyal EYE TRAY Procedure Packs Recalled Due to 3M Steri Drape Recall

    DeRoyal Industries is recalling EYE TRAY procedure packs containing recalled 3M Health Care Steri Drapes. The recall affects 180 kits distributed across multiple U.S. states.

    Product
    DeRoyal EYE TRAY PGYBK, REF 89-7978.02
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0643-2023·2022-12-21

    Voluntary Recall of DeRoyal Biopsy Pack Medical Device Kits

    DeRoyal Industries initiated a voluntary recall of 560 biopsy pack kits (lot 56094211) distributed across multiple US states. The specific reason for the recall was not documented in the available source.

    Product
    DeRoyal BIOPSY PACK, REF 89-9270.04
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0632-2023·2022-12-21

    FDA Class II Recall: DeRoyal Laminectomy Spinal Fusion Surgical Packs

    DeRoyal Industries has voluntarily recalled 90 kits of laminectomy spinal fusion surgical packs. The recall affects units distributed across 23 U.S. states. The specific reason for recall was not disclosed in available materials.

    Product
    DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.09
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0599-2023·2022-12-21

    DeRoyal BASIC NEURO PACK Medical Device Recall with Unspecified Reason

    DeRoyal Industries is recalling 288 BASIC NEURO PACK medical device kits distributed across 23 U.S. states. The reason for the recall is not specified in available documentation.

    Product
    DeRoyal BASIC NEURO PACK, REF 89-7523.15
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0683-2023·2022-12-21

    Medical device recall issued for DeRoyal CRANI PACK across multiple states

    DeRoyal Industries issued a voluntary recall of 6 kits of DeRoyal CRANI PACK devices (Lot 56388307) distributed across 23 U.S. states. The specific reason for recall was not disclosed in available documentation.

    Product
    DeRoyal CRANI PACK, REF 89-10242.02
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0615-2023·2022-12-21

    DeRoyal SPINE PACK procedure kits recalled due to recalled Steri Drapes

    DeRoyal SPINE PACK kits have been recalled because they contain 3M Health Care Steri Drapes components that have been previously recalled. Affected units should not be used.

    Product
    DeRoyal SPINE PACK, REF 89-8361.10
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0563-2023·2022-12-21

    DeRoyal Extremity Trays Recalled Due to Affected 3M Steri Drapes

    DeRoyal is recalling its EXTREMITY TRAY procedure packs because they contain recalled 3M Health Care Steri Drapes. The affected kits are distributed across multiple U.S. states.

    Product
    DeRoyal EXTREMITY TRAY PGYBK, REF 89-4081.07
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0612-2023·2022-12-21

    Medical Device Recall: DeRoyal Podiatry Pack, Class II

    DeRoyal Industries Inc voluntarily recalled 102 kits of its podiatry pack (Lot 57593741, exp. 1/1/2027). The recall affects 22 US states; the specific reason is not detailed in available source material.

    Product
    DeRoyal PODIATRY PACK, REF 89-8359.13
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0605-2023·2022-12-21

    Medical Device Recall: GEO-MED Upper Extremity Pack Kit

    DeRoyal Industries initiated a voluntary recall of 243 GEO-MED Upper Extremity Pack kits distributed across 23 US states. The specific reason for the recall is not available in the source material.

    Product
    GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0669-2023·2022-12-21

    FDA Class II recall: DeRoyal posterior laminectomy microdisc pack

    DeRoyal Industries initiated a recall of its POSTERIOR LAMI MICRODISC PACK, an FDA Class II medical device. The reason for this recall was not disclosed in available documentation.

    Product
    DeRoyal POSTERIOR LAMI MICRODISC PACK, REF 89-10059.02
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0650-2023·2022-12-21

    Medical Device Shoulder Pack Recall Initiated by Manufacturer

    DeRoyal Industries initiated a voluntary recall of 32 kits of its Shoulder Pack medical device distributed across 23 U.S. states. The specific reason for the recall was not provided in the source documentation.

    Product
    DeRoyal SHOULDER PACK, REF 89-9449.12
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0620-2023·2022-12-21

    FDA Recalls GEO-MED Podiatry Pack Medical Device Kit

    DeRoyal Industries voluntarily recalls GEO-MED Podiatry Pack medical device kits distributed across 23 US states. The specific reason for recall is not detailed in available source materials.

    Product
    GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0673-2023·2022-12-21

    DeRoyal NEURO PACK medical device recalled by manufacturer across United States

    DeRoyal Industries has voluntarily recalled 162 NEURO PACK neurological medical device kits distributed across 23 U.S. states. The reason for the recall was not disclosed by the manufacturer.

    Product
    DeRoyal NEURO PACK, REF 89-10171.03
    Category
    Medical Device
    Distribution
    0 states