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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10376–10400 of 13820

  • HighFDA (Devices)·Z-0607-2023·2022-12-21

    FDA Recalls DeRoyal BASIC EYE PACK Medical Device Kits

    The FDA has issued a recall of 50 kits of DeRoyal BASIC EYE PACK, a medical device distributed across 23 U.S. states. The specific reason for the recall is not provided in available source information.

    Product
    DeRoyal BASIC EYE PACK, REF 89-8337.09
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0638-2023·2022-12-21

    FDA Class II recall of DeRoyal FOOT PACK medical devices

    DeRoyal Industries Inc has recalled 350 kits of the DeRoyal FOOT PACK medical device in a Class II FDA recall. The specific reason for the recall was not publicly disclosed in available agency records.

    Product
    DeRoyal FOOT PACK, REF 89-9252.06
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0516-2023·2022-12-21

    Stradis Healthcare Major Extremity Surgical Kits Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling Henry Schein Major Extremity surgical kits due to incomplete outer bag sealing that could compromise kit sterility. Affected kits were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, MAJOR EXTREMITY PACK, Item No.570-2783,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2023·2022-12-21

    Medical and Surgical Procedure Trays Recalled Due to Incomplete Sealing

    Stradis Medical is recalling medical and surgical procedure kits with potentially incompletely sealed outer bags that may compromise sterility. Affected healthcare facilities should stop using these kits immediately.

    Product
    HENRY SCHEIN, OMFS, Item No.570-2779,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0569-2023·2022-12-21

    DeRoyal PICC line trays recalled due to sterile drape defects

    DeRoyal Industries is recalling 918 PICC line procedure packs containing 3M sterile drapes that were separately recalled. The affected kits were distributed across 23 U.S. states to healthcare facilities.

    Product
    DeRoyal PICC LINE TRAY PGYBK, REF 89-6150.13
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0486-2023·2022-12-21

    STRADIS HEALTHCARE Oral Surgery Trays Recalled for Potential Sterility Breach

    Stradis Medical is recalling STRADIS HEALTHCARE oral surgery trays because the outer bag may be incompletely sealed, risking sterility compromise. No illnesses have been reported.

    Product
    STRADIS HEALTHCARE, Surgical Pk, Item No.40510TWS, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0540-2023·2022-12-21

    Surgical Procedure Trays with Potentially Compromised Sterile Packaging

    Stradis Healthcare is recalling surgical procedure trays due to potentially incomplete outer bag sealing that may compromise product sterility. Affected units were distributed nationwide in the US and Canada.

    Product
    STRADIS HEALTHCARE, Phleb, Item No.682-1425,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0473-2023·2022-12-21

    BBL Chocolate II Agar laboratory culture media recalled for nutrient deficiency

    BBL Chocolate II Agar culture media manufactured by Becton Dickinson contains reduced nutrients and may cause false negative results in laboratory bacterial identification testing.

    Product
    BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267
    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-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
  • HighFDA (Devices)·Z-0480-2023·2022-12-21

    Ethicon PDS II Surgical Sutures Recalled for Deficient Knot Strength

    Ethicon recalls PDS II violet monofilament sutures due to significantly reduced knot tensile strength, posing risk of intra-operative breakage in surgical procedures. The affected lot was distributed internationally to Canada, Japan, Australia, and New Zealand.

    Product
    PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0591-2023·2022-12-21

    DeRoyal procedure packs recalled for containing affected Steri Drapes

    DeRoyal Industries is recalling its BASIC NEURO PACK procedure packs because they contain 3M Health Care Steri Drapes that have been recalled. The recall affects 96 kits (lot 57287655, expires 9/1/2026) distributed to 23 states.

    Product
    DeRoyal BASIC NEURO PACK, REF 89-7258.12
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0526-2023·2022-12-21

    Surgical procedure kit recalled due to incompletely sealed outer bag

    A HENRY SCHEIN extremity pack surgical kit is being recalled because its outer bag may not be completely sealed, which could compromise the sterility of the kit. Affected units were distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, EXTREMITY PACK, Item No.570-2946
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0715-2023·2022-12-21

    DeRoyal Cataract Surgery Packs Recalled for Defective Components

    DeRoyal cataract procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. The recall includes 520 kits distributed to healthcare facilities.

    Product
    DeRoyal CATARACT PACK, REF 89-10086.05
    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
    0 states
  • 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-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-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-0537-2023·2022-12-21

    Stradis Healthcare Phlebectomy Pack Recall Due to Sterility Breach Risk

    Stradis Healthcare recalls its Phlebectomy Pack (Item No. 682-001) due to incomplete sealing of outer bags, which may compromise sterility of surgical kits distributed nationwide.

    Product
    STRADIS HEALTHCARE, Phlebectomy Pack, Item No.682-001,
    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-0530-2023·2022-12-21

    Single-shot epidural kits recalled due to incomplete outer bag sealing

    Stradis Medical is recalling 80 Henry Schein single-shot epidural kits due to potentially incomplete outer bag sealing that could compromise sterility. The recall affects units distributed nationwide in the US and Canada.

    Product
    HENRY SCHEIN, SINGLE SHOT EPIDURAL, Item No.570-3089
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0490-2023·2022-12-21

    Surgical Procedure Tray Recall Due to Incomplete Packaging Seal

    Stradis Healthcare is recalling oral surgery trays with potentially incompletely sealed packaging that may compromise sterility. No illnesses reported.

    Product
    STRADIS HEALTHCARE, Surg Pk, Item No.40714IES, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0574-2023·2022-12-21

    FDA Class II recall: DeRoyal surgical procedure pack distributed to multiple states

    DeRoyal Industries voluntarily recalled 3 kits of its OPEN SHOULDER PROCEDURE PACK RF (Lot 56391733, expiring 3/1/2024) starting November 2022. The recall affects multiple U.S. states.

    Product
    DeRoyal OPEN SHOULDER PROCEDURE PACK RF, REF 89-6629.07
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0453-2023·2022-12-21

    Intra-Aortic Balloon Pump Recalled for Potential Short Battery Runtime

    The Arrow AutoCAT2WAVE intra-aortic balloon pump is recalled due to a potential issue with short battery run-times. The FDA Class I recall affects 4 units distributed worldwide.

    Product
    Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
    Category
    Medical Device
    Distribution
    0 states