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 the agency’s own highest classification or reported deaths or serious injuries, 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

23476–23500 of 40299

  • HighFDA (Devices)·Z-2194-2018·2018-06-20

    Angiodynamics Recalls Bio-Stable Kits Due to Bacterial Endotoxin Risk

    Angiodynamics Inc. is recalling Bio-Stable 5F kits because components may contain unsafe levels of bacterial endotoxins.

    Product
    Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG, Catalog Number 45-887
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-2148-2018·2018-06-20

    Sun Med Recalls Adult Manual Resuscitators Due to Port Detachment Risk

    Sun Med, LLC is recalling 5 cases of Medline Adult Manual Resuscitators because the patient port retaining ring may not fully seat, potentially detaching during use and impacting air delivery.

    Product
    MEDLINE ADULT MANUAL RESUSCITATOR WITH MEDIUM ADULT MASK, BAG RESERVOIR, FILTER, CO2 AND 7 FT. OXYGEN TUBING, REF CPRM1116FC
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2139-2018·2018-06-20

    Ion Beam Applications Recalls Proteus ONE and Plus Devices

    Ion Beam Applications is recalling Proteus ONE and Proteus Plus medical devices because unauthorized modifications or third-party accessories may pose a safety risk.

    Product
    Proteus ONE and Proteus Plus
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2144-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recall for Missing Warning Statements

    Philips is recalling 94 IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2183-2018·2018-06-20

    Zimmer Biomet Recalls Vanguard Knee System Tibial Bearings Due to Labeling Error

    Zimmer Biomet is recalling 169 Vanguard Knee System PS Tibial Bearings because the label master file was incorrectly set up, though the physical product is correctly marked.

    Product
    Vanguard Knee System PS Tibial Bearing, Part Number 183621 Intended for use in knee joint replacement procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2137-2018·2018-06-20

    Thermo Fisher Recalls Remel SUPERPACK CS/ 500 SEG/FLASK Due to Performance Failure

    Thermo Fisher is recalling 67 units of Remel SUPERPACK CS/ 500 SEG/FLASK because the product may fail performance testing for Staphylococcus aureus.

    Product
    remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH W/OXACILLIN Product Usage: Recommended for the use in qualitative procedures to screen Staphylococcus aureus for resistance to penicillinase- resistance penicillins (e.g., methicillin, nafcillin…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2164-2018·2018-06-20

    BioMérieux Recalls VITEK 2 Gram-Positive Cards Due to Temperature Excursion

    BioMérieux is recalling VITEK 2 Gram-Positive identification cards in Guadeloupe because a shipment experienced a temperature excursion exceeding acceptable limits.

    Product
    The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2 Systems for the automated identification of most significant Gram-positive organisms. The VITEK 2 GP identification card Is a single-use disposable. GP TEST KIT VTK2 20 CARTES A…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2170-2018·2018-06-20

    BioMérieux PREVI Color Gram Reagents Recalled Due to Temperature Excursion

    BioMérieux is recalling PREVI Color Gram reagents shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.

    Product
    The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method. The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2162-2018·2018-06-20

    Keystone Dental Recalls Mislabeled Prima Plus Dental Implants

    Keystone Dental Inc is recalling 72 Prima Plus dental implants due to mislabeling. The devices were distributed to dental professionals in 14 US states.

    Product
    Prima Plus ¿4.1 x 11.5mm Implant, Catalog Number 15737K Keystone Dental implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including cement retained, or overdenture restorations, and…
    Category
    Medical Device
    Distribution
    14 states
  • ModerateFDA (Devices)·Z-2141-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recall for Missing Warning Statements

    Philips is recalling IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2171-2018·2018-06-20

    BioMérieux Recalls Color Gram 2 Stains Due to Temperature Excursion

    BioMérieux is recalling Color Gram 2 stains in Guadeloupe after a shipment experienced a temperature excursion exceeding acceptable limits.

    Product
    Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal microorganisms for direct examination, according to the Gram method. Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2169-2018·2018-06-20

    BioMérieux Recalls VIDAS TOXO IgG Avidity Test Due to Temperature Excursion

    BioMérieux is recalling VIDAS TOXO IgG Avidity tests because a shipment to Guadeloupe exceeded temperature limits. The products were delivered to customers despite quarantine instructions.

    Product
    VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family instruments, for the determination of anti-toxoplasma IgG avidity in human serum or plasma (lithium heparin, sodium citrate, EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay).…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2165-2018·2018-06-20

    BioMérieux Recalls VITEK 2 NH Cards Due to Temperature Excursion

    BioMérieux is recalling VITEK 2 Neisseria-Haemophilus identification cards in Guadeloupe that were exposed to temperatures exceeding acceptable limits.

    Product
    The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the VITEK 2 Systems for the automated identification of most clinically significant fastidious organisms. The VITEK 2 NH identification card is a single-use disposable. A microorganism…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2184-2018·2018-06-20

    CellaVision DM Software Recall for LIS Data Transmission Malfunction

    Cellavision AB is recalling CellaVision DM Software versions 6.0.1 and 6.0.2 due to a malfunction where cell comments are not sent to the Laboratory Information System.

    Product
    CellaVision DM Software versions 6.0.1 or 6.0.2 installed on the following products: CellaVision DM96, DM1200, DM9600 and DI-60 Product Usage: The devices are automated cell-locating devices. The devices automatically locates and presents images of blood cells on peripheral…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2168-2018·2018-06-20

    BioMérieux Recalls VITEK 2 Gram Negative Susceptibility Cards Due to Temperature Excursion

    BioMérieux is recalling VITEK 2 Gram Negative Susceptibility Cards shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.

    Product
    The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram negative bacilli to antimicrobial agents. Fully automated short-term…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2163-2018·2018-06-20

    Smith & Nephew Recalls GENESIS II Tibial Punches Due to Size Defect

    Smith & Nephew is recalling 5 units of GENESIS II 13 mm tibial punches because they are 2 mm smaller than the specified size.

    Product
    smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1)
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2166-2018·2018-06-20

    BioMerieux VITEK 2 ANC Card Recalled Due to Temperature Excursion

    BioMerieux is recalling VITEK 2 ANC identification cards shipped to Guadeloupe that experienced a temperature excursion exceeding acceptable limits.

    Product
    The VITEK¿ 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use with the VITEK¿ 2 Systems for the automated identification of most clinically significant anaerobic organisms and Corynebatcerium species. The VITEK¿ 2 ANC identification card is a single-use…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2142-2018·2018-06-20

    Philips IntelliVue MX40 Patient Monitor Recalled for Missing Warning Statements

    Philips is recalling 7,178 IntelliVue MX40 Patient Monitors because five warning statements are missing from the instructions for use.

    Product
    IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
    Category
    Medical Device
    Distribution
    53 states
  • ModerateFDA (Devices)·Z-2167-2018·2018-06-20

    BioMérieux Recalls VITEK 2 Gram Positive Susceptibility Cards Due to Temperature Excursion

    BioMérieux is recalling VITEK 2 Gram Positive Susceptibility Cards in Guadeloupe because a shipment experienced a temperature excursion up to 47.8°C, exceeding acceptable limits.

    Product
    The VITEK¿ 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents. Fully automated…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2172-2018·2018-06-20

    BioMérieux Recalls Oxidase Reagent Due to Temperature Excursion in Guadeloupe

    BioMérieux is recalling Oxidase Reagent (ref: 55635) in Guadeloupe after a shipment experienced temperature excursions up to 47.8°C, exceeding acceptable limits.

    Product
    Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria. This enzyme is characteristic of the genus Neisseria and most species of Pseudomonas. It enables the differentiation of Gram (-) bacilli (1, 2). A…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-2140-2018·2018-06-20

    Immunalysis Recalls EDDP Urine Control Set Due to Specification Failure

    Immunalysis is recalling 37 kits of EDDP Urine Control Set 1 because the High control fails to meet specifications, potentially producing inaccurate test results.

    Product
    lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/ml and Low 75 ng/ml) are used as control materials in the ammonolysis EDDP Specific Urine Enzyme Immunoassay, which has a cutoff of 100 ng/ml. This test provides only a preliminary analytical test…
    Category
    Medical Device
    Distribution
    14 states
  • SevereFDA (Devices)·Z-2118-2018·2018-06-13

    Orthofix Recalls Rival Reduce Kit Plates Due to Screw Engagement Failure

    Orthofix, Inc. is voluntarily recalling 50 units of Rival Reduce Kit Plates because locking screws failed to properly engage the plates during surgery.

    Product
    Rival Reduce Kit Plates, Sterile, Rx Only, ORTHOFIX S.r.r. Italy on label, Part Number: 000-K-012C
    Category
    Medical Device
    Distribution
    19 states
  • SevereFDA (Devices)·Z-2046-2018·2018-06-13

    Draeger Jaundice Meter JM-103 Recalled for Measurement Display Misinterpretation

    Draeger Medical Systems is recalling the Jaundice Meter JM-103 because users may misinterpret the out-of-range display as a zero measurement.

    Product
    Draeger Jaundice Meter JM-103 The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infants. The device is not intended as a standalone for diagnosis of…
    Category
    Medical Device
    Distribution
    Distributed nationwide