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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10476–10500 of 13816

  • HighFDA (Devices)·Z-0645-2023·2022-12-21

    Medical Device Recall: DeRoyal TOTAL KNEE PACK surgical kit

    DeRoyal Industries recalled 48 kits of the TOTAL KNEE PACK surgical product in November 2022. The specific reason for the recall was not disclosed in the public notice.

    Product
    DeRoyal TOTAL KNEE PACK, REF 89-9300.08
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0511-2023·2022-12-21

    Surgical Procedure Trays Recalled for Potential Sterile Barrier Compromise

    Stradis Medical is recalling 104 units of Henry Schein ENT surgical procedure trays due to incomplete sealing of the outer bag, which may compromise the sterility of the kit.

    Product
    HENRY SCHEIN, ENT PACK, Item No.570-2718
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0633-2023·2022-12-21

    DeRoyal Laminectomy Spinal Fusion Pack Recalled by FDA (Class II)

    DeRoyal Industries voluntarily recalled 100 kits of its laminectomy spinal fusion pack after identifying a device defect. The recall affects medical facilities in 23 states.

    Product
    DeRoyal LAMINECTOMY SPINAL FUSION PACK, REF 89-9105.10
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0555-2023·2022-12-21

    Surgical procedure trays recalled due to incomplete outer bag sealing

    Stradis Healthcare is recalling surgical procedure trays that may have incompletely sealed outer bags, risking sterility breach. Sixteen units were distributed nationwide and in Canada.

    Product
    STRADIS HEALTHCARE, Breast, Item No.693-276,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2023·2022-12-21

    Leica Provido surgical microscope models at risk of unexpected power shutdown

    Leica Provido surgical microscope systems may experience unexpected shutdown due to power supply overheating. Affected units should be identified by serial number and serviced immediately.

    Product
    Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
    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-0484-2023·2022-12-21

    BASIC IMPLANT PACK Recalled for Incomplete Outer Bag Sealing

    Stradis Medical is recalling the BASIC IMPLANT PACK (Item 40310SBI) due to incomplete outer bag sealing that may compromise sterility. 80 units were distributed nationwide and in Canada.

    Product
    BASIC IMPLANT PACK, Item No. 40310SBI, oral surgery tray
    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
  • HighFDA (Devices)·Z-0481-2023·2022-12-21

    STRADIS HEALTHCARE Eye Surgical Kits Recalled for Incomplete Sealing

    STRADIS HEALTHCARE WECKCELL EYE SPEARS surgical kits (Item 9430, 9431) are recalled due to incomplete outer bag sealing that may compromise kit sterility. Approximately 80 kits distributed in the US and Canada are affected.

    Product
    STRADIS HEALTHCARE, WECKCELL EYE SPEARS, Item Numbers: a) 9430, b) 9431
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0549-2023·2022-12-21

    Endovenous Procedure Packs Recalled for Incomplete Bag Sealing

    Stradis Healthcare is recalling Endovenous Packs due to incompletely sealed outer bags that may compromise kit sterility. No illnesses have been reported.

    Product
    www.StradisHealthcare.com, Endovenous Pack, Item No.682-494,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0635-2023·2022-12-21

    DeRoyal hip surgical pack recalled in voluntary Class II action

    DeRoyal Industries is recalling 8 kits of its TOTAL HIP PACK (Lot 57460930) distributed across 23 U.S. states in a voluntary Class II FDA recall.

    Product
    DeRoyal TOTAL HIP PACK, REF 89-9113.07
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0475-2023·2022-12-21

    Surgical microscope power supply may overheat and cause unexpected shutdown

    Leica Microsystems is recalling 43 Proveo 8 surgical microscopes nationwide due to a potential power supply defect that may cause device overheating and unexpected shutdown during use.

    Product
    Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2023·2022-12-21

    Surgical Microscope Power Supply May Overheat and Cause Unexpected Shutdown

    Leica surgical microscopes (M530 OHX) may experience power supply overheating due to component overstressing, which can cause unexpected device shutdown. 148 units nationwide are affected.

    Product
    Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-0703-2023·2022-12-21

    FDA Medical Device Recall: DeRoyal Pacemaker ICD Pack

    DeRoyal Industries initiated a voluntary recall of its PACEMAKER ICD PACK (Lot 57805969, exp. 11/1/2026). The specific reason for recall is not provided in available source documentation. Affected units were distributed across 23 U.S. states.

    Product
    DeRoyal PACEMAKER ICD PACK, REF 89-10902.01
    Category
    Medical Device
    Distribution
    0 states
  • 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-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
    0 states
  • HighFDA (Devices)·Z-0629-2023·2022-12-21

    Medical Device: DeRoyal HEART B PACK Recalled by FDA

    DeRoyal Industries initiated a Class II recall of its HEART B PACK medical device kit affecting 68 units distributed across 23 US states (Lot 56613762, expires 6/1/2026). The specific reason for recall is not available in source documentation.

    Product
    DeRoyal KIT HEART B PACK, REF 89-9042.07
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-0559-2023·2022-12-21

    NUVASIVE MAGEC 2 Rod Spinal Bracing System Recalled for Sterile Packaging Failure

    NuVasive is recalling the MAGEC 2 Rod spinal bracing system due to potential failure of the sterile packaging barrier, which could compromise device sterility.

    Product
    NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of scoliosis. REF Model Numbers/NSO Item #/Product Description MC2-4590S / PA0684-001 / MAGEC 2 Rod, 4.5mm 90mm Standard MC2-5590S / PA0684-002 / MAGEC 2 Rod
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0427-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump: Short Battery Run-Time Issue

    Arrow International is recalling 6 refurbished Arrow AutoCAT2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times. The affected devices may not operate for sufficient duration during medical use.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump
    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-0491-2023·2022-12-21

    Stradis Healthcare Oral Surgery Trays Recalled Due to Incomplete Sealing

    Stradis Healthcare is recalling oral surgery trays due to incomplete outer bag sealing that may compromise the sterility of the surgical kit.

    Product
    STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray
    Category
    Medical Device
    Distribution
    Distributed nationwide