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 the agency’s own highest classification or reported deaths or serious injuries, 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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11176–11200 of 40095

  • HighFDA (Devices)·Z-0538-2023·2022-12-21

    Stradis Healthcare Thoracic Surgery Kits Recalled for Sterility Risk

    Thoracic Phleb procedure kits from Stradis Healthcare are being recalled due to incomplete outer bag sealing during manufacturing, which may compromise kit sterility.

    Product
    STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0514-2023·2022-12-21

    ENT Surgical Kits Recalled for Potential Sterility Loss

    Stradis Medical is recalling HENRY SCHEIN ENT surgical kits distributed nationwide due to defective outer bag sealing that may compromise sterility. Affected kits were distributed across the US and Canada.

    Product
    HENRY SCHEIN, ENT SET UP PACK, Item No.570-2742
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0667-2023·2022-12-21

    DeRoyal ACDF surgical implant kit recall, Class II, reason undisclosed

    DeRoyal is recalling 63 ACDF surgical implant kits distributed to 23 US states. This is a voluntary, Class II recall announced November 2022, with no reported illnesses or injuries.

    Product
    DeRoyal ACDF PACK PGYBK A PACK / B PACK, REF 89-9997.06
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0493-2023·2022-12-21

    Stradis Healthcare Dental Implant Trays Recalled Due to Incomplete Sealing

    Stradis Healthcare is recalling dental implant trays with incomplete outer bag seals that may compromise sterility. Affected units were distributed in the US and Canada.

    Product
    STRADIS HEALTHCARE, Implants, Item No.41015NSI, dental tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0430-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump short battery run-time issue

    Arrow International is recalling 88 units of Arrow AutoCAT2 Intra-Aortic Balloon Pumps worldwide due to a potential issue with short battery run-times. Affected cardiac support devices may not operate reliably.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0597-2023·2022-12-21

    DeRoyal Spinal Fusion Packs Recalled for Containing Affected 3M Steri Drapes

    DeRoyal procedure kits for spinal fusion are being recalled because they contain 3M Health Care Steri Drapes that have been recalled by 3M. The affected 16 kits were distributed to healthcare facilities in 23 US states.

    Product
    DeRoyal SPINAL FUSION PACK, REF 89-7515.13
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0508-2023·2022-12-21

    Surgical Procedure Trays Recalled for Potential Sterility Breach

    Stradis Medical recalls surgical procedure trays due to incomplete outer bag sealing that may compromise sterility. The affected products were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, Basin Set, Item No.570-1803
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0548-2023·2022-12-21

    Stradis Healthcare Surgical Procedure Kits Recalled for Incomplete Sealing

    Stradis Medical recalls Vein & Laser surgical procedure kits due to incomplete outer bag sealing that may compromise sterility. The recall affects 10 units distributed in the US and Canada.

    Product
    STRADIS HEALTHCARE, Vein & Laser, Item No.682-334R1,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0676-2023·2022-12-21

    Medical Device Kit Recall: DeRoyal CRANI PACK Lot 56705261

    DeRoyal Industries is recalling 16 units of the DeRoyal CRANI PACK (Lot 56705261, expiring 6/1/2025) distributed across multiple U.S. states. The specific reason for this Class II recall is not disclosed in the source notice.

    Product
    DeRoyal CRANI PACK, REF 89-10202.03
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0649-2023·2022-12-21

    DeRoyal Endovascular Tracepack Medical Device Recall, FDA Class II

    DeRoyal Industries initiated a Class II recall of 495 endovascular tracepack kits distributed across 23 U.S. states due to an unspecified manufacturing concern.

    Product
    DeRoyal ENDOVASCULAR TRACEPACK, REF 89-9350.03
    Category
    Medical Device
    Distribution
    23 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
    23 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
    23 states
  • ModerateFDA (Devices)·Z-0663-2023·2022-12-21

    Medical Device Recall: DeRoyal Breast Augmentation Pack Class II

    DeRoyal Industries initiated a voluntary Class II recall of 70 kits of its Breast Augmentation Pack distributed across 23 US states. The specific reason for the recall is not stated in available FDA materials.

    Product
    DeRoyal BREAST AUGMENTATION PACK, REF 89-9618.05
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0577-2023·2022-12-21

    GEO-MED PLASTIC HAND PACK RF Medical Device Recall

    DeRoyal Industries Inc is recalling 102 kits of the GEO-MED PLASTIC HAND PACK RF. The reason for the recall is not publicly specified. The recall affects 23 US states and was voluntarily initiated by the manufacturer.

    Product
    GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0652-2023·2022-12-21

    FDA Class II: DeRoyal Trauma Pack Voluntary Recall

    DeRoyal Industries initiated a voluntary recall of EMERGENT TRAUMA PACK kits (18 units) distributed to hospitals and medical facilities across 23 US states. The specific reason for the recall was not disclosed in the FDA notification.

    Product
    DeRoyal EMERGENT TRAUMA PACK, ref 89-9453.12
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0594-2023·2022-12-21

    Medical device recall: DeRoyal Retinal Pack kits

    DeRoyal Industries recalled 64 DeRoyal Retinal Pack kits (Lot 57000221, Lot 57413324) distributed across 23 U.S. states. The specific reason for the recall was not disclosed.

    Product
    DeRoyal RETINAL PACK, REF 89-7336.07
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0625-2023·2022-12-21

    Voluntary recall of DeRoyal ACDF Pack surgical implant kits

    A voluntary recall of 45 DeRoyal ACDF Pack surgical implant kits affects multiple US states. The recall reason was not specified in the available notice.

    Product
    DeRoyal ACDF PACK, REF 89-8779.03
    Category
    Medical Device
    Distribution
    23 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
    23 states
  • ModerateFDA (Devices)·Z-0631-2023·2022-12-21

    DeRoyal Laminectomy Spinal Fusion Surgical Pack Recall (Class II)

    DeRoyal Industries is recalling 180 kits of laminectomy spinal fusion surgical packs distributed across 23 states. The reason for recall is not specified in the available source.

    Product
    DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.08
    Category
    Medical Device
    Distribution
    23 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
    23 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
    23 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
    23 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
    23 states
  • ModerateFDA (Devices)·Z-0639-2023·2022-12-21

    DeRoyal Foot Pack Medical Device Class II Recall

    DeRoyal Industries has initiated a voluntary Class II recall of 217 kits of its DeRoyal Foot Pack (REF 89-9252.07). The recall affects multiple U.S. states.

    Product
    DeRoyal FOOT PACK, REF 89-9252.07
    Category
    Medical Device
    Distribution
    23 states
  • ModerateFDA (Devices)·Z-0579-2023·2022-12-21

    DeRoyal SHOULDER PACK Medical Device Recall Class II

    DeRoyal Industries Inc is recalling 876 kits of the DeRoyal SHOULDER PACK (REF 89-6830.13) due to an unspecified reason for recall. The affected product was distributed across 23 U.S. states.

    Product
    DeRoyal SHOULDER PACK, REF 89-6830.13
    Category
    Medical Device
    Distribution
    23 states