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

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Minimum severity

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

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21501–21525 of 40339

  • ModerateFDA (Devices)·Z-0747-2019·2019-01-23

    Ethicon Recalls PERMA-HAND Silk Sutures Due to Labeling Mismatch

    Ethicon is recalling 840 units of PERMA-HAND Silk Sutures because the product inside the packaging does not match the size or type indicated on the label.

    Product
    PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Drugs)·D-0371-2019·2019-01-23

    Recall of Curaplex Epi Safe Kits Due to Expired Epinephrine Vials

    Bound Tree Medical is recalling 84 Curaplex Epi Safe Administration and Training Kits because the epinephrine vials inside expired in December 2018, despite the outer label showing January 2020.

    Product
    curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe Administration Kit (8600-01101) and 1 Epi Safe Training Kit (8600-01102), Rx Only. Distributed by Sarnova HC, LLC's family of companies: Bound Tree Medical, LLC, Cardio Partners, Inc.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0379-2019·2019-01-23

    Bound Tree Medical Recalls Curaplex Epi Safe Kits Due to Labeling Errors

    Bound Tree Medical is recalling 747 Curaplex Epi Safe Kits because they are incorrectly labeled with an expiration date of May 2018 instead of May 2019, and the syringe component lacks 510(k) clearance.

    Product
    Curaplex Epi Safe Kit, Rx Only, contains: 1mL Vial of Epinephrine, 1 Epi-Safe Syringe, 1 Safety needle, 2 Alcohol Prep Pads,1 Adhesive Dressing, 1 Insert. Distributed by Sarnova, HC. LLC's family companies: Bound Tree Medical. LLC, Cardio Partners, Inc., Emergency Medical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • ModerateFDA (Devices)·Z-0702-2019·2019-01-16

    Cardinal Health Recalls Presource Kit Total Joint Pack Due to Sterility Concerns

    Cardinal Health Inc. is recalling 182 Presource Kit Total Joint Packs distributed in Florida because the double-wrapped basin component is not supported by current sterility assurance validation.

    Product
    Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0693-2019·2019-01-16

    GE Healthcare Recalls MRI Systems Due to Possible Incorrect Software Version

    GE Healthcare is recalling 3,849 MRI systems worldwide because they may have an incorrect software version loaded.

    Product
    Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0708-2019·2019-01-16

    Biomet DVR Crosslock Screws Recalled for Incorrect Length Labeling

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

    Product
    Biomet DVR Crosslock Screws- 2.7mm x 20mm, Sterile ITEM 131827120 Product 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 the…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0707-2019·2019-01-16

    Siemens Biograph Horizon PET/CT System Recalled for Design Defects

    Siemens Medical Solutions USA is recalling 171 Biograph Horizon PET/CT systems worldwide due to improper design or specifications.

    Product
    Siemens Biograph Horizon PET/CT System, Product Usage: The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0705-2019·2019-01-16

    Mevion Medical Systems Recalls MEVION S250i Medical Device

    Mevion Medical Systems is recalling one MEVION S250i unit due to a dDose1 interlock trip. Treatment may continue via partials.

    Product
    MEVION S250i
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0700-2019·2019-01-16

    Boston Scientific Recalls IntellaTip MiFi Ablation Catheters in Japan

    Boston Scientific is recalling 1,282 IntellaTip MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.

    Product
    IntellaTip MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0699-2019·2019-01-16

    Boston Scientific Recalls Blazer Ablation Catheters Due to Resin Changes

    Boston Scientific is recalling 1,282 Blazer Open-Irrigated Ablation Catheters in Japan because resin sub-supplier changes caused material variations not reflected in internal documentation.

    Product
    Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli…
    Category
    Medical Device
    Distribution
    0 states
  • LowFDA (Devices)·Z-0701-2019·2019-01-16

    Boston Scientific Recalls IntellaNav Ablation Catheters in Japan

    Boston Scientific is recalling IntellaNav MiFi Open-Irrigated Ablation Catheters in Japan due to unapproved resin material variations.

    Product
    IntellaNav MiFi Open-Irrigated Ablation Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli…
    Category
    Medical Device
    Distribution
    0 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