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

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

6626–6650 of 40007

  • HighFDA (Devices)·Z-2391-2024·2024-07-24

    Infusomat UNIV. 15 IV Pump Set Recalled for Backflow Hazard

    B. Braun Medical is recalling 32,752 units of the Infusomat UNIV. 15 DR pump tubing set due to potential backcheck valve malfunction that could cause medication backflow between IV containers and medication loss.

    Product
    Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363424
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2376-2024·2024-07-24

    IV infusion set recalled due to backcheck valve malfunction

    B. Braun is recalling OUTLOOK IV sets due to potential backcheck valve malfunction that could allow medication to flow backward between IV containers and prevent proper priming, potentially resulting in patient injury.

    Product
    OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354212
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2400-2024·2024-07-24

    Infusomat SPACE IV Pump Set Recalled for Backcheck Valve Malfunction

    B. Braun is recalling Infusomat SPACE IV pump sets due to a backcheck valve malfunction that could cause medication to flow backward into the primary IV container and prevent proper priming of the line.

    Product
    Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490103
    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-2351-2024·2024-07-24

    BD Multitest 6-Color TBNK Reagent Contamination May Cause Erroneous Results

    BD Multitest 6-Color TBNK flow cytometry reagent contains contaminated antibodies that may produce erroneous or delayed test results, potentially impacting clinical decisions.

    Product
    BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166; BD Multitest 6-Color TBNK, IVD, REF: 662967; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes IVD, REF: 662995. BD Multitest" 6-Color TBNK reagent wit
    Category
    Medical Device
    Distribution
    34 states
  • 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-2370-2024·2024-07-24

    UNITRAX Hip Implant Head Component Recalled for Package Label Size Mismatch

    Howmedica Osteonics is recalling UNITRAX hip implant head components because the package label size may not match the device actually inside, potentially leading to incorrect surgical implantation. Affected units were distributed worldwide.

    Product
    UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2379-2024·2024-07-24

    Infusion Pump Sets Recalled for Potential Backflow of Medication

    B. Braun is recalling Infusomat UNIV. 15 IV pump sets due to a backcheck valve malfunction that could divert medication between containers and prevent proper priming.

    Product
    Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 362033
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2378-2024·2024-07-24

    IV Pump Infusion Set Backcheck Valve May Malfunction and Cause Medication Backflow

    B. Braun is recalling the Infusomat UNIV.15DROP PUMP SET (Model 362032) because the backcheck valve may malfunction, allowing medication to flow backward from secondary to primary IV containers, risking medication loss and adverse drug reactions.

    Product
    Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2387-2024·2024-07-24

    B. Braun Infusomat SPACE IV Set Backcheck Valve Malfunction Recall

    B. Braun Medical is recalling 68,205 Infusomat SPACE IV Sets due to a potential backcheck valve malfunction that could allow medication backflow between IV containers.

    Product
    Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363420
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2372-2024·2024-07-24

    UNITRAX Hip Endoprosthesis Head Components Mislabeled with Incorrect Package Sizes

    Howmedica Osteonics Corp. is recalling UNITRAX Endoprosthesis Head Components because the package label size may not match the actual device inside. Mislabeling could result in the wrong implant size being used during hip surgery.

    Product
    UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2371-2024·2024-07-24

    Hip Prosthesis Component Mislabeled; Package Size May Not Match Device

    Howmedica Osteonics is recalling 18 units of UNITRAX Endoprosthesis Head Components due to mislabeled package sizes. The label may not match the actual device size inside.

    Product
    UNITRAX Endoprosthesis Head Component - 42mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-042
    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-2393-2024·2024-07-24

    IV Infusion Pump Set Backcheck Valve Malfunction Recall

    B. Braun Medical recalls Infusomat UNIV. 15 DROP PUMP SET due to backcheck valve malfunction that could cause medication backflow and loss of medication, resulting in 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: 363433
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2368-2024·2024-07-24

    Abbott Recalls Proclaim 7 Elite Pulse Generator for Battery Life Discrepancy

    Abbott Medical is recalling Proclaim 7 Elite Implantable Pulse Generators because the device may reach end of service sooner than indicated in the product labeling. Patients should consult their healthcare provider.

    Product
    Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
    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-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-2399-2024·2024-07-24

    IV Infusion Pump Sets Recalled for Backcheck Valve Malfunction

    B. Braun is recalling Infusomat IV infusion pump sets due to potential backcheck valve malfunction that can cause medication to flow backward between IV containers and prevent proper medication delivery.

    Product
    Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number 490102
    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-2411-2024·2024-07-24

    Endo Model SL Tibial Components Recalled for Inoperable Blind Screws

    Waldemar Link is recalling Endo Model SL Tibial Components used in knee replacement surgery because the blind screws on the modular components cannot be loosened during surgery, potentially prolonging procedures and forcing surgeons to change their planned approach.

    Product
    Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medi
    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-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-2366-2024·2024-07-24

    Abbott Proclaim Plus 7 implantable pulse generator recalled for shortened service life

    Abbott recalls 1,086 Proclaim Plus 7 implantable pulse generators due to labeling inaccuracy. Devices may reach end of service sooner than labeled, potentially reducing the time patients have to plan for replacement.

    Product
    Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide