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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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

5726–5750 of 13512

  • ModerateFDA (Devices)·Z-2422-2024·2024-07-31

    MIC-KEY Gastric-Jejunal Feeding Tube Kits Recalled for Incomplete Safety Information

    Avanos Medical is recalling MIC-KEY Gastric-Jejunal Feeding Tube Kits because the Instructions for Use were missing required risk information about potential complications. No illnesses have been reported.

    Product
    MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 0270xx (Non-ENFIT); and MIC-KEY* Gastric-Jejunal Feeding Tube Kit, Extension Sets with ENFit Connectors, Endoscopic / Radiologic Placement, Low-Profile GJ-Tube, REF 8270xx, ste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-2319-2024·2024-07-24

    Abiomed Impella CP with SmartAssist heart pump units recalled for failed inspection

    Abiomed is recalling 9 Impella CP with SmartAssist heart pump units that failed inspection and were inadvertently released. The devices were distributed in Florida, Massachusetts, Ohio, and Texas.

    Product
    Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Devices)·Z-2322-2024·2024-07-24

    Volara System Blue Ventilator Adapter Module Handset Plug Disconnection

    Baxter Healthcare is recalling 350 units of the Volara System Blue Ventilator Adapter Module because the handset plug may disconnect from the nebulizer port, disrupting ventilator gas flow. Affected units were distributed nationwide and internationally.

    Product
    Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2321-2024·2024-07-24

    Ventilation Device Handset Plug May Disconnect from Nebulizer Adapter

    Baxter's Volara System SPU circuit kits may have a faulty handset plug that disconnects from the nebulizer adapter, preventing proper ventilator gas flow.

    Product
    Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. Intermittent positive pressure breathing device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2382-2024·2024-07-24

    IV Infusion Pump Set Recalled for Backcheck Valve Malfunction Risk

    B. Braun is recalling Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY (Model 362420) IV infusion sets due to backcheck valve malfunction that can cause medication to flow backward from secondary to primary IV containers.

    Product
    Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362420
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2374-2024·2024-07-24

    BD Pyxis Automated Dispensing Cabinets Software Error Prevents Medication Access

    BD Pyxis automated dispensing cabinets with ES 1.7.x software may display errors preventing medication access when Component Manager is in 'installed mode' and patch KB 5033688 is applied.

    Product
    BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2395-2024·2024-07-24

    Infusomat SPACE Pump IV Set Recalled Due to Backcheck Valve Malfunction

    B. Braun Medical is recalling the Infusomat SPACE IV pump set (Model 480255) due to potential backcheck valve malfunction that could allow medication to flow backward between IV containers, potentially causing adverse drug reactions or loss of medication.

    Product
    Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480255
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2396-2024·2024-07-24

    Infusomat SPACE IV infusion sets recalled for backcheck valve malfunction

    Infusomat SPACE IV infusion sets are recalled due to a backcheck valve defect that may cause medication to flow backward into primary IV bags, potentially resulting in medication loss or adverse drug reactions.

    Product
    Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 480263
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2390-2024·2024-07-24

    Infusion Pump Set Recalled Due to Valve Malfunction Risk

    B. Braun's Infusomat UNIV. 60 infusion pump sets are recalled due to backcheck valve malfunction that may cause medication backflow from secondary to primary IV bags, risking adverse drug reactions or medication loss.

    Product
    Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363423
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2394-2024·2024-07-24

    Infusomat SPACE Pump IV Sets Recalled for Backcheck Valve Malfunction

    B. Braun's Infusomat SPACE Pump IV sets are recalled due to a potential backcheck valve malfunction that could cause medication backflow and inability to prime. The defect affects approximately 109,464 units distributed in the US and Canada.

    Product
    Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480254
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2360-2024·2024-07-24

    Abbott Proclaim XR 7 Implantable Pulse Generator Service Life Shorter Than Labeled

    Abbott Proclaim XR 7 implantable pulse generators may have a shorter service life than indicated in product labeling. Approximately 9,006 units distributed worldwide are affected.

    Product
    Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2408-2024·2024-07-24

    High Flow Insufflation Tubing Recalled for Incomplete Seals

    Canadian Hospital Specialties is recalling HIGH FLOW INSUFFLATION TUBING with incomplete seals that may result in non-sterile product. The defect affects 6,300 units and poses patient safety concerns.

    Product
    Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2406-2024·2024-07-24

    Surgical Hemostatic Device Recalled for Compromised Sterile Barrier

    Ethicon is recalling SURGICEL FIBRILLAR hemostatic pads due to torn foil pouches that compromise the sterile barrier, traced to a specific packaging machine defect.

    Product
    SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1961
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2363-2024·2024-07-24

    Abbott Proclaim 7 Pulse Generator Battery Life Shorter Than Labeled

    Abbott is recalling approximately 457 Proclaim 7 Implantable Pulse Generators because the battery may reach end of service sooner than indicated in labeling. Patients may require unexpected device replacement.

    Product
    Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2349-2024·2024-07-24

    Cascade IOMAX Cortical Module recalled for defective circuit board

    Cascade IOMAX Cortical Module devices are recalled due to a defective printed circuit board that may cause unintended electrical stimulation. Affected units were distributed in the U.S. and internationally.

    Product
    Cascade IOMAX Cortical Module, REF: 190296-200
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2355-2024·2024-07-24

    Knee walker recalled for tiller separation that may cause falls

    Medical Depot is recalling the Nitro Glide Knee Walker (model 791RD) because the tiller can separate from the base assembly, potentially causing users to fall. The recall affects 667 units distributed nationwide and in Canada.

    Product
    Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791RD (Red)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2373-2024·2024-07-24

    Horizon Bone Densitometer Devices Recalled for Electromagnetic Compatibility Issues

    Hologic Inc. is recalling 2,642 Horizon X-Ray Bone Densitometer units due to non-conformance with electromagnetic compatibility safety standards. The devices exceeded acceptable limits per international technical standard IEC 60601-1-2.

    Product
    Horizon X-Ray Bone Densitometer (DXA) Models: Horizon-A, Horizon-W, Horizon-WI, Horizon-C, Horizon-CI, Horizon-A-CN, Horizon-W-CN, Horizon-WI-CN, Horizon-CI-CN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2383-2024·2024-07-24

    B. Braun Infusomat IV Pump Set Recalled Due to Backflow Risk

    B. Braun Medical recalls Infusomat UNIV. 15 DROP PUMP SET units due to a potential backcheck valve malfunction that could cause medication backflow and adverse drug reactions.

    Product
    Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362431
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2358-2024·2024-07-24

    Abbott Proclaim XR 5 Implantable Pulse Generator Battery Labeling Error

    Abbott Proclaim XR 5 implantable pulse generators may reach end of service sooner than product labeling indicates, affecting approximately 83,511 units worldwide. Patients should contact their healthcare provider for guidance on device monitoring and replacement planning.

    Product
    Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2404-2024·2024-07-24

    IV Infusion Pump Set Recalled for Backflow Risk During Medication Administration

    B. Braun Medical is recalling the OUTLOOK PUMP SET 3 IV infusion sets due to a potential backcheck valve malfunction that could cause medication to backflow from secondary containers into primary containers, risking adverse drug reactions and medication loss.

    Product
    OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2361-2024·2024-07-24

    Abbott Proclaim 7 Implantable Pulse Generator May Reach End-of-Service Sooner Than Labeled

    Abbott is recalling 569 units of the Proclaim 7 implantable pulse generator because the device may reach end-of-service sooner than indicated in labeling. All affected units were distributed worldwide.

    Product
    Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2389-2024·2024-07-24

    Infusion Pump Component Valve Malfunction May Cause Medication Backflow

    B. Braun's Infusomat infusion pump component can malfunction, causing medication to flow backward from secondary IV lines into primary lines, potentially resulting in improper medication delivery and patient harm.

    Product
    Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2405-2024·2024-07-24

    Zimmer Tourniquet Cuff Recalled Due to Incorrect Port Configuration Labeling

    Stryker is recalling 90 units of Zimmer Tourniquet Cuff 30" because packaging labels them as dual port single bladder, but they actually contain a single port single bladder configuration.

    Product
    REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2354-2024·2024-07-24

    Knee Walker Tiller Separation Risk Recalled Due to Fall Hazard

    Medical Depot is recalling Nitro Glide Knee Walker Model 791BL units due to a defect where the tiller may separate from the base assembly. If the device fails, users may fall and sustain injury.

    Product
    Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791BL (Blue)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2367-2024·2024-07-24

    Abbott Proclaim DRG implantable pulse generator service life shorter than labeled

    Abbott is recalling 21,843 Proclaim DRG implantable pulse generators because the duration between the device's elective replacement indicator and end of service may be shorter than stated in product labeling.

    Product
    Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide