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.

Filters

Agency

Category

Minimum severity

Clear filters

10276–10300 of 13731

  • SevereFDA (Devices)·Z-0444-2023·2022-12-21

    Arrow AutoCAT 2 Intra-Aortic Balloon Pump Short Battery Runtime Recall

    Arrow International is recalling the Arrow AutoCAT 2 Intra-Aortic Balloon Pump (IABP) due to a potential issue with short battery run-times. The recall affects 29 units distributed worldwide.

    Product
    Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0351-2023·2022-12-21

    Arrow MAC Two-Lumen Central Venous Access Kit connector housing defect

    ARROW INTERNATIONAL is recalling Arrow MAC Two-Lumen Central Venous Access Kits due to potential inadequate connection between the top and bottom housings of included Micro Clave Clear Connectors.

    Product
    Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0433-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Battery Run-Time Issue

    Arrow International is recalling the AutoCAT2 Intra-Aortic Balloon Pump worldwide due to a potential issue with short battery run-times. All lot and serial numbers are affected.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0445-2023·2022-12-21

    Arrow AutoCAT 2 Cardiac Pump Recalled for Potential Battery Runtime Issue

    Arrow International is recalling Arrow AutoCAT 2 intra-aortic balloon pumps worldwide due to a potential issue with battery run-times.

    Product
    Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0352-2023·2022-12-21

    Central Venous Catheter Kits Recalled for Potential Connector Housing Failure

    ARROW INTERNATIONAL is recalling 1,275 units of Arrowg+ard Blue Plus CVC kits due to inadequate connections in Micro Clave Clear Connectors. Units distributed in six states.

    Product
    Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer
    Category
    Medical Device
    Distribution
    6 states
  • SevereFDA (Devices)·Z-0435-2023·2022-12-21

    Arrow AutoCAT2 Intra-Aortic Balloon Pump Recalled for Short Battery Run-Times

    Arrow AutoCAT2 intra-aortic balloon pumps may experience shorter battery run-times than specified, affecting device reliability in cardiac care. The FDA has issued a Class I recall for all affected units worldwide.

    Product
    Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0440-2023·2022-12-21

    Arrow AC3 Optimus intra-aortic balloon pump short battery runtime

    Arrow AC3 Optimus cardiac pumps may experience short battery run-times. The FDA has issued a Class I recall for all units worldwide.

    Product
    Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump
    Category
    Medical Device
    Distribution
    0 states
  • 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-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-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-0717-2023·2022-12-21

    Diagnostic Kit Recall: Falsely Elevated Mold Allergen Test Results

    Siemens IMMULITE 2000 allergen testing kits may produce falsely elevated results for mold allergen-specific IgE, potentially leading to incorrect mold allergy diagnoses.

    Product
    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Material Number (SMN): 10380875 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-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-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-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-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-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-0470-2023·2022-12-21

    Zimmer NexGen Stemmed Tibial Components recalled for higher revision rates

    Zimmer is voluntarily recalling NexGen Option Stemmed Tibial Component Size 7 (1,049 units) due to higher-than-expected revision rates when used with specific femoral components, based on UK registry data.

    Product
    NexGen Option Stemmed Tibial Component Size 7, Item Number 00-5986-057-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0500-2023·2022-12-21

    Stradis Healthcare Introducer Kit Micro recalled for potential sterility compromise

    Stradis Healthcare is recalling 180 units of its Introducer Kit Micro cardiovascular devices due to potential incomplete sealing of outer bags that may compromise sterility.

    Product
    STRADIS HEALTHCARE, Introducer Kit Micro, Item No.525-038, cardiovascular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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
    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-0562-2023·2022-12-21

    DeRoyal Procedure Packs Recalled Due to Included 3M Steri Drapes

    DeRoyal Industries recalls EYE PACK procedure kits because they contain 3M Health Care Steri Drapes that have been recalled. The recall affects 156 kits distributed across 23 U.S. states.

    Product
    DeRoyal EYE PACK, REF 89-4051.09
    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