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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13126–13150 of 27500

  • HighFDA (Devices)·Z-2865-2020·2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2838-2020·2020-09-02

    Datascope Intra-Aortic Balloon Catheters Recalled for Potential Endotoxin Contamination

    Datascope is recalling Intra-Aortic Balloon Catheters due to potential endotoxin contamination. The recall affects 1,746 kits distributed worldwide.

    Product
    Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02, 0684-00-0478-02U - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2860-2020·2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-1510-2020·2020-08-26

    CareFusion Recalls ChloraPrep Applicators Due to Non-Sterility

    CareFusion is recalling ChloraPrep With Tint applicators because they are not sterile and contain Aspergillus Penicilloides.

    Product
    ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11
    Category
    Medical Device
    Distribution
    2 states
  • CriticalFDA (Drugs)·D-1511-2020·2020-08-26

    CareFusion Chlorhexidine Applicators Recalled for Non-Sterility

    CareFusion 213, LLC is recalling ChlroraPrep One-Step applicators due to the presence of Aspergillus Penicilloides.

    Product
    ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2821-2020·2020-08-26

    Arjo Huntleigh Recalls Citadel Plus Bariatric Bed Frames Due to Melting Cables

    Arjo Huntleigh is recalling 145 Citadel Plus Bariatric Bed Frame Systems because Modular Junction Box cables can melt, potentially affecting bed functionality.

    Product
    Bariatric Bed Frame System The Citadel Plus Bariatric Bed Frame System is intended for the acute and post-acute care environments. It is not intended for use in the home care environment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2828-2020·2020-08-26

    NobelReplace Dental Implant Recall Due to Incorrect Measurement Labeling

    Nobel Biocare is recalling 188 NobelReplace dental implants because the cap label incorrectly lists measurements as 5.0x8mm instead of the actual 4.3x10mm.

    Product
    NobelReplace Conical Connection (CC) PMC RP 4.3x10mm, REF: 37291 - Product Usage: implants are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements to restore chewing function.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2805-2020·2020-08-26

    PVA PREVENT Emergency Ventilator Recalled for Potential Incomplete Air Delivery

    Precision Valve & Automation is recalling three PVA PREVENT emergency ventilators due to a software error that may cause false alarms or incomplete air delivery cycles.

    Product
    PVA, PREVENT is an FDA-authorized emergency ventilator designed to treat patients suffering from COVID-19 respiratory failure. This motorized device automatically compresses a resuscitator bag to provide air to the lungs of a COVID-19 patient, eliminating the human error and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2816-2020·2020-08-26

    DePuy Synthes LCP Plate Recall Due to Dimensional Tolerance Issues

    Synthes (USA) Products LLC is recalling 191 units of DePuy Synthes Trauma LCP One-Third Tubular Plates because dimensional features may be out of tolerance, potentially reducing locking strength.

    Product
    DePuy Synthes Trauma LCP One-Third Tubular Plate with Collar 8 Holes / 93mm - Product Usage: intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia and fibula, particularly in osteopenic bone.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2807-2020·2020-08-26

    Chembio DPP COVID-19 IgM/IgG System Recalled for Performance Issues

    Chembio Diagnostics is recalling 7,674 kits of the DPP COVID-19 IgM/IgG System because the FDA revoked its Emergency Use Authorization due to performance issues.

    Product
    Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in fingerstick whole blood, venous whole blood, serum, or plasma (lithium…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2818-2020·2020-08-26

    Smith & Nephew Recalls Single RIKKI Retractors Due to Improper Heat Treatment

    Smith & Nephew is recalling 111 units of Single RIKKI Retractors because they were improperly heat treated. The devices are used during surgery to hold soft tissue away from the surgical site.

    Product
    Single RIKKI Retractor, Catalog #71934609 - Product Usage: is used during surgery to hold soft tissue away from the surgical site.
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2817-2020·2020-08-26

    Golden Technologies Lift Chair Recalled for Suspected Poor Weld

    Golden Technologies is recalling 251 Model PR515 Lift Chairs due to a suspected poor weld on the back KD bar.

    Product
    Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to provide lift assistance for persons who have difficulty rising from a seated position to a standing position.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2794-2020·2020-08-19

    Philips HeartStart MRx Monitor/Defibrillators Recalled for Therapy Switch Failure

    Philips is recalling HeartStart MRx monitor/defibrillators because a therapy switch failure may prevent the device from delivering the intended shock energy or function.

    Product
    Philips HeartStart MRx, Monitor/Defibrillators with model numbers M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6, M3536M7, M3536M8, M3536M9 - Product Usage: is intended for use in hospital and pre-hospital settings by qualified medical personnel…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2795-2020·2020-08-19

    Bioseal Trachea Extenders Recalled for Stress Cracks and Leakage Risk

    Bioseal Corporation is recalling 900 units of Trachea Extenders due to stress cracks that may cause breathing system leakage, potentially preventing prescribed ventilation from reaching patients.

    Product
    Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2780-2020·2020-08-19

    Maquet Holder HKHZ 19 Recalled for Insecure Oxygenator Fit

    Maquet is recalling Holder HKHZ 19 units for Quadrox-i and Quadrox-iD oxygenators because the holder may not securely hold the oxygenator.

    Product
    Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal / Pediatric oxygenator and is being used as a single holder for QUADROX i and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2775-2020·2020-08-19

    Luminex Verigene Processor SP Recalled for Potential False Negative Results

    Luminex is recalling Verigene Processor SP systems because an instrument failure may cause false negative results for Gram-positive and Gram-negative blood culture tests.

    Product
    Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2773-2020·2020-08-19

    Ion Beam Applications Recalls Proteus 235 Proton Therapy Systems

    Ion Beam Applications is recalling four Proteus 235 Proton Therapy Systems because a software defect prevents users with long names from resuming interrupted treatments.

    Product
    Proteus 235 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 by radiation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2778-2020·2020-08-19

    Anjon Holdings Recalls Spinal Bone Fixation Fasteners Due to Galling

    Anjon Holdings is recalling 249 Anjon Bremer Molded Crown bone fixation fasteners because of a high rate of galling in a threaded component.

    Product
    Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2770-2020·2020-08-19

    Ortho VITROS Anti-SARS-CoV-2 Reagent Recalled for Potential False Negatives

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 Total Reagent because swapped bottles may cause false negative or delayed results.

    Product
    VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2799-2020·2020-08-19

    United Imaging Recalls uEXPLORER PET/CT System for Potential Sharp Edges

    Shanghai United Imaging Healthcare is recalling one uEXPLORER PET/CT Diagnostic Imaging System in Texas due to potential sharp edges and image data issues.

    Product
    uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2800-2020·2020-08-19

    United Imaging Recalls uMI 550 PET/CT Systems Due to Imaging and Safety Defects

    Shanghai United Imaging Healthcare is recalling four uMI 550 PET/CT systems due to defects that may cause image artifacts, scanning interruptions, or sharp edges.

    Product
    uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2785-2020·2020-08-19

    Flower Orthopedics Recalls Calcaneus Plates Due to Incorrect Material Usage

    Flower Orthopedics is recalling 25 calcaneus plates because the contract manufacturer used a titanium alloy instead of pure titanium.

    Product
    Calcaneus Plate, Extensile, Small, Right, Catalog Number CPF 201 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2771-2020·2020-08-19

    Ortho Clinical Diagnostics Recalls VITROS Anti-SARS-CoV-2 IgG Reagent Packs

    Ortho Clinical Diagnostics is recalling VITROS Anti-SARS-CoV-2 IgG Reagent Packs because swapped reagent bottles may cause false negative or delayed results.

    Product
    VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency authorization use only.
    Category
    Medical Device
    Distribution
    Distributed nationwide