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.

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16401–16425 of 27471

  • HighFDA (Devices)·Z-0730-2019·2019-01-23

    Smith & Nephew Recalls SL Plus Mia Double Offset Adapter Units

    Smith & Nephew is recalling 72 units of the SL Plus Mia Double Offset Adapter because a pin may not be properly mounted and could disassemble.

    Product
    SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0749-2019·2019-01-23

    U by Kotex Sleek Regular Tampons Recalled for Potential Breakage

    Kimberly-Clark is recalling U by Kotex Sleek Regular Tampons because they may come apart upon removal.

    Product
    U by Kotex¿ Sleek¿, Regular Tampons, 34 Count
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0734-2019·2019-01-23

    Zimmer Biomet Recalls Compression Tray Bases Due to Silicone Shedding

    Zimmer Biomet is recalling 971 Maximum Variable Pitch Compression Tray Bases because they may shed silicone during cleaning and sterilization.

    Product
    Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0732-2019·2019-01-23

    Meridian Premier Cryptococcal Antigen Test Recalled for Stability Issues

    Meridian Bioscience is recalling Premier Cryptococcal Antigen kits because an enzyme reagent may not maintain stability, potentially causing false negative results.

    Product
    PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0733-2019·2019-01-23

    Waldemar Link LINK STEM Reconstruction Prosthesis Recalled for Depth Defect

    Waldemar Link is recalling 11 LINK STEM Reconstruction Prostheses because a manufacturing defect prevents the reaming guide from reaching the intended depth, which may lead to incorrect surgical positioning.

    Product
    LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK¿ STEM with Microporous Surface MP¿ Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0745-2019·2019-01-23

    Bayer Medical Care Recalls MAVIG Portegra Overhead Counterpoise Systems

    Bayer Medical Care is recalling MAVIG Portegra and Portegra2 Overhead Counterpoise Systems because the head mount knob may not be properly tightened, causing the injector head to become loose or fall.

    Product
    MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjunction with the Medrad Stellant CT Injection System (Certegra Workstation), Medrad Mark 7 Arterion" Injection System, or Medrad Mark V ProVis Injection System, Catalog Numbers: Catalog numbers: OCS CEIL…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0731-2019·2019-01-23

    Conformis iTotal Hip Replacement System Reamed with Incorrect Interference Fit

    Conformis, Inc. is recalling one iTotal Hip Replacement System because the reamer instruments used had a -1mm interference fit instead of the expected -2mm.

    Product
    iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0697-2019·2019-01-16

    Swissray Medical Recalls ddRCombi Plus FP X-ray Systems Due to Lifting Column Defect

    Swissray Medical AG is recalling three ddRCombi Plus FP X-ray systems because a lifting column component may break, causing the arm to drop and potentially seriously injure patients or users.

    Product
    ddRCombi Plus FP, Model Number 8.2000.0070.0 (US Version), 8.2000.0060.0 (Europe Version) The ddRCombi Plus FP is a fully digital, multifunctional X-ray system that allows the direct digitization of X-ray information without use of cassettes or other media. It can perform all…
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0692-2019·2019-01-16

    Agfa-Gevaert Recalls DX-D 600 Direct Radiography Systems Due to Movement Defect

    Agfa-Gevaert is recalling 10 DX-D 600 Direct Radiography Systems because the Overhead Tube Crane may continue moving after the control button is released.

    Product
    DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600 system is a ceiling mounted General Radiography X-Ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-Ray…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0694-2019·2019-01-16

    Philips Ingenia MRI Systems Recalled for Table Movement Safety Issue

    Philips is recalling Ingenia Elition S and X MRI systems because pressing the Stop Table button during automatic movement may cause the table to restart unexpectedly.

    Product
    Ingenia Elition S, Ingenia Elition X
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0695-2019·2019-01-16

    Ethicon Hemorrhoidal Circular Stapler Recalled for Missing Washer

    Ethicon Endo-Surgery Inc is recalling 480 units of the PROXIMATE HCS Hemorrhoidal Circular Stapler because some units may lack a washer, potentially causing bleeding or soft tissue injury during use.

    Product
    PROXIMATE¿ HCS Hemorrhoidal Circular Stapler Product Code: PPH01 PPH01: The PROXIMATE¿ HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0703-2019·2019-01-16

    GE Healthcare Recalls Nuclear Medicine Imaging Systems Due to Collimator Locking Hazard

    GE Healthcare is recalling 339 Discover VH/Millennium VG Nuclear Medicine Imaging Systems worldwide because a collimator locking handle may fail to engage, posing a potential hazard to patients during scans.

    Product
    Discover VH/Millennium VG Nuclear Medicine Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0696-2019·2019-01-16

    Ethicon Recalls PROXIMATE PPH Hemorrhoidal Circular Staplers Due to Missing Washer

    Ethicon Endo-Surgery Inc is recalling 15,264 units of PROXIMATE PPH Hemorrhoidal Circular Staplers because they may be missing a washer, potentially causing bleeding or soft tissue injury during use.

    Product
    PROXIMATE¿ PPH Hemorrhoidal Circular Stapler Product Code:PPH03 PPH03: The PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0709-2019·2019-01-16

    Biomet DVR Crosslock Screws Recalled Due to Incorrect Length Labeling

    Zimmer Biomet is recalling two lots of Biomet DVR Crosslock Screws because the actual screw lengths do not match the labels.

    Product
    Biomet DVR Crosslock Screws- 2.7mm x18mm, Sterile ITEM 131827118 Product Usage: Usage: The system is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions (osteotomies) of small bones of…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0698-2019·2019-01-16

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling seven Proteus 235 proton therapy systems due to a risk of detachment of the Compact Gantry Rolling Floor.

    Product
    Proteus 235 Product Usage: The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0706-2019·2019-01-16

    Elekta Unity MRI Speakers May Become Dislodged and Enter Bore

    Elekta Limited is recalling two Elekta Unity MRI systems because speakers can become dislodged and be pulled into the bore in rare circumstances.

    Product
    Elekta Unity
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Devices)·Z-0552-2019·2019-01-09

    Medtronic StealthStation Cranial Software Recall for Biopsy Depth Gauge Error

    Medtronic is recalling StealthStation Cranial and Synergy Cranial software due to an incorrect display of the Biopsy Depth Gauge that resulted in the biopsy of healthy tissue.

    Product
    StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for cranial procedures using optical localization StealthStation Cranial version 3.0, 3.1 CE 0344 Rx Only 2018-02 9735489 Revision 3 Medtronic Navigation, Inc.…
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0688-2019·2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS HBeAg Reagent Due to Biased Results

    Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS HBeAg Reagent because biotin interference may cause inaccurate test results.

    Product
    VITROS HBeAg Reagent, Cat. No 6801819 Product Usage: For the in vitro qualitative detection of hepatitis B e antigen (HBeAg) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of hepatitis or who may be at risk for hepatitis B virus…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2019·2019-01-09

    Ortho-Clinical Diagnostics Recalls VITROS NT-proBNP Reagent for Biased Results

    Ortho-Clinical Diagnostics is extending a 2018 recall of VITROS NT-proBNP Reagent because it may produce biased results at low biotin concentrations.

    Product
    VITROS NT-proBNP Reagent, Cat No. 6802156 Product Usage: For in vitro diagnostic use only. For the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0681-2019·2019-01-02

    Medical Action Industries Recalls Laparotomy Sponges Due to Sterility Compromise

    Medical Action Industries is recalling 2,600 laparotomy sponges because a breach of the sterile barrier may have compromised product sterility.

    Product
    Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0683-2019·2019-01-02

    Medtronic MiniMed Insulin Pumps Recalled for Missing Audio Alerts

    Medtronic is recalling specific MiniMed insulin pump models because software version 4.10 may fail to play expected audio sounds during alerts, alarms, or sirens.

    Product
    Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G (International)
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-0674-2019·2019-01-02

    Tosoh Bioscience Recalls ST AIA-PACK Testosterone Diagnostic Test Kits

    Tosoh Bioscience is voluntarily recalling ST AIA-PACK Testosterone kits due to a Class II defect. The recall covers 26,745 units distributed nationwide.

    Product
    ST AIA-PACK Testosterone (TES) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum on specific Tosoh AIA System analyzers. Measurement of testosterone is used to aid in the diagnosis and management of conditions involving…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0663-2019·2019-01-02

    ICU Medical Recalls Iced Thermoset Closed-Loop Injectate Delivery Systems

    ICU Medical is recalling Iced Thermoset Closed-Loop Injectate Delivery Systems due to a defect in the thermoset check valve that may cause leakage.

    Product
    Iced Thermoset Closed-Loop Injectate Delivery System for cold Injectate. 1 unit per Cavity #2-4"x9" Cav/20 pieces per case R1-15645
    Category
    Medical Device
    Distribution
    31 states