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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8876–8900 of 27393

  • HighFDA (Devices)·Z-0547-2023·2022-12-21

    Stradis Healthcare Medical Vein Kits Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling Medical Vein procedure kits due to potentially incomplete sealing of the outer bag that may compromise kit sterility. No illnesses or injuries have been reported.

    Product
    STRADIS HEALTHCARE, Medical Vein, Item No.682-330,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0483-2023·2022-12-21

    Surgical Procedure Kits Recalled by Stradis Healthcare for Sealing Defect

    Stradis Healthcare is recalling surgical procedure kits for perioral surgery due to a manufacturing defect that may result in incomplete outer bag sealing. This could compromise the sterility of the kits.

    Product
    STRADIS HEALTHCARE, Perio Surgery, Item No. 20177RPSS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-0545-2023·2022-12-21

    Stradis Healthcare Vein RF Pack surgical trays recalled for incomplete outer bag seal

    Stradis Healthcare is recalling 400 units of Vein RF Pack surgical trays due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility.

    Product
    STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,
    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
  • HighFDA (Devices)·Z-0534-2023·2022-12-21

    Medical Insertion Tray Recalled for Incomplete Sterile Bag Sealing

    Stradis Medical is recalling Henry Schein ILR Insertion Trays due to incomplete outer bag sealing that may compromise sterility. No illnesses have been reported.

    Product
    HENRY SCHEIN, ILR Insertion Tray, Item No.570-3131
    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
    23 states
  • HighFDA (Devices)·Z-0495-2023·2022-12-21

    Dental surgical kits recalled due to incomplete outer bag sealing

    Stradis Healthcare is recalling dental surgical procedure kits due to manufacturing issues that may result in incompletely sealed outer bags, potentially compromising kit sterility.

    Product
    STRADIS HEALTHCARE, DENTAL CUSTOM PACK, Item No.41137TDS,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2023·2022-12-21

    Medical Procedure Trays Recalled for Potential Sterility Breach

    Stradis Healthcare is recalling 100 units of Henry Schein CATH PACK kits due to manufacturing defects that may leave outer bags incompletely sealed, potentially compromising sterility.

    Product
    HENRY SCHEIN, CATH PACK Item No.570-2789
    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
    23 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-0708-2023·2022-12-21

    DeRoyal recalls Class II TRACECART POSTEROR LAMI MICRODISC device

    DeRoyal Industries is recalling 72 kits of TRACECART POSTEROR LAMI MICRODISC TRACECART devices distributed across 23 U.S. states in a voluntary Class II recall initiated by the manufacturer.

    Product
    DeRoyal TRACECART POSTEROR LAMI MICRODISC TRACECART, REF 53-1960.02
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0718-2023·2022-12-21

    Siemens allergy test kits recalled for false mold allergen reactivity results

    Siemens Healthcare Diagnostics is recalling 560 allergy diagnostic kits (Lot 565) due to potential for falsely elevated mold allergen reactivity, which may result in incorrect test results.

    Product
    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0498-2023·2022-12-21

    Stradis Healthcare Cotton Applicator 3 inch kits recalled due to incomplete bag sealing

    Stradis Healthcare is recalling cotton applicator 3 inch kits used in medical and surgical procedures due to incomplete outer bag sealing that may compromise kit sterility. Kits were distributed nationwide in the U.S. and Canada.

    Product
    STRADIS HEALTHCARE, COTTON APPLICATOR 3" Item No.505-010,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0686-2023·2022-12-21

    Medical Device Recall: DeRoyal HAND PACK Kit Lot 57685848

    DeRoyal Industries Inc is voluntarily recalling DeRoyal HAND PACK kits (Lot 57685848) distributed across 23 US states. The reason for recall has not been publicly disclosed.

    Product
    DeRoyal HAND PACK, REF 89-10314.03
    Category
    Medical Device
    Distribution
    23 states
  • 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-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-0489-2023·2022-12-21

    Surgical dental procedure kits recalled due to incomplete bag sealing

    Stradis Healthcare is recalling surgical and dental procedure kits due to manufacturing defects that may result in incomplete outer bag sealing and compromised sterility.

    Product
    STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental
    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-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-0598-2023·2022-12-21

    DeRoyal Spinal Fusion Procedure Packs Recalled for 3M Drape Issue

    DeRoyal spinal fusion procedure packs containing recalled 3M Health Care Steri Drapes are being recalled. Affected kits were distributed to healthcare facilities across 23 U.S. states.

    Product
    DeRoyal SPINAL FUSION PACK, REF 89-7515.14
    Category
    Medical Device
    Distribution
    23 states
  • 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
    23 states
  • HighFDA (Devices)·Z-0488-2023·2022-12-21

    Stradis Healthcare Oral Surgery Implant Packs Recalled for Incomplete Seal Defect

    Stradis Medical recalled 20 oral surgery implant packs with incomplete outer bag sealing that may compromise sterility. Affected lot numbers are 22228490663 and 22242491516, distributed in the US and Canada. No illnesses reported.

    Product
    STRADIS HEALTHCARE, Basic Implant Pack, Item No.40561BIP, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide