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

6601–6625 of 40007

  • HighFDA (Devices)·Z-2433-2024·2024-07-31

    Infusion Pump Syringe Compatibility Issue May Cause Overdose or Underdose

    B Braun is recalling Perfusor Space infusion pumps due to syringe compatibility issues with Cardinal Health Monoject syringes. The incompatibility may cause overdose, underdose, therapy delays, and alarm failures.

    Product
    Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2426-2024·2024-07-31

    ABL800 FLEX Blood Gas Analyzers May Report Inaccurate pH Results

    Radiometer Medical ABL800 FLEX blood gas analyzers (models 393-800, 393-801) may report inaccurate pH results due to bacterial growth in calibration solution bottles. Approximately 27,127 units distributed worldwide are affected.

    Product
    ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglob
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2439-2024·2024-07-31

    Medical device diagnostic software vulnerability causes potential application crashes

    Siemens Sensis Vibe diagnostic systems may crash when documentation functionality is used during certain reporting events. Seven units were distributed to facilities nationwide.

    Product
    Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER Model: 10765502-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2425-2024·2024-07-31

    Cystatin C Diagnostic Reagent Marketed Without FDA 510(k) Clearance

    Randox Laboratories is recalling 115 kits of RX Series CYSC Cystatin C Reagent because it was marketed without required FDA 510(k) clearance. Healthcare facilities should discontinue use and contact the manufacturer.

    Product
    RX Series CYSC- Cystatin C Reagent -Intended for in vitro diagnostic (IVD) use as Randox Cystatin C assay on automated analysers. Catalogue Number: CYS4004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-2398-2024·2024-07-24

    IV Infusion Pump Set Recalled for Medication Backflow Risk

    B. Braun's Infusomat 60 IV infusion pump set is being recalled due to a backcheck valve that may malfunction, allowing medication to flow backward between IV containers and preventing proper priming of the line.

    Product
    Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2388-2024·2024-07-24

    Infusion pump IV administration set recalled for backcheck valve malfunction risk

    B. Braun is recalling Infusomat UNIV. 15 DROP PUMP SET infusion sets due to potential backcheck valve malfunction that may cause medication to flow backward into primary IV containers and prevent proper priming, risking adverse drug reactions.

    Product
    Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363421
    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-2397-2024·2024-07-24

    IV Infusion Pump Set Valve May Cause Dangerous Medication Backflow

    B. Braun's Infusomat pump sets may have faulty backcheck valves causing medication to backflow between IV bags, risking reduced medication delivery and adverse reactions. All units distributed worldwide after August 2023 are affected.

    Product
    Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2362-2024·2024-07-24

    Abbott Proclaim 5 Pulse Generator May Have Shorter Than Labeled Battery Duration

    Abbott Proclaim 5 Implantable Pulse Generators may have a shorter battery lifespan than labeled, potentially affecting replacement timing for patients.

    Product
    Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2377-2024·2024-07-24

    IV Infusion Set Backcheck Valve Malfunction May Cause Medication Loss

    B. Braun is recalling OUTLOOK IV Sets due to potential backcheck valve malfunction that could allow medication backflow and loss. The defect may result in adverse drug reactions or medication loss.

    Product
    OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354213
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2403-2024·2024-07-24

    IV Infusion Pump Set Recalled for Backcheck Valve Malfunction Risk

    B. Braun is recalling the Infusomat UNIV. 15 DROP PUMP SET due to potential backcheck valve malfunction that could cause medication backflow and loss. The defect may result in adverse drug reactions or improper medication delivery.

    Product
    Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 363230
    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-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-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
  • 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-2380-2024·2024-07-24

    Infusomat IV Pump Set Recalled for Backcheck Valve Malfunction

    The Infusomat 60DROP METRISET PUMP SET may experience backcheck valve malfunction, causing medication to flow backward between IV containers and loss of medication. This could result in adverse drug reactions or inability to administer medication properly.

    Product
    Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362034
    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-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-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-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-2392-2024·2024-07-24

    Infusomat UNIV. 15 IV Pump Set Recalls Due to Backcheck Valve Malfunction

    B. Braun is recalling Infusomat UNIV. 15 IV pump sets because the backcheck valve may malfunction, potentially causing medication backflow or loss, which could lead to adverse drug reactions.

    Product
    Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363430
    Category
    Medical Device
    Distribution
    Distributed nationwide