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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16376–16400 of 39988

  • 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
  • ModerateFDA (Devices)·Z-2848-2020·2020-09-02

    Siemens Cios Alpha and Spin Mobile X-Ray Systems Recalled for Electrical Malfunction

    Siemens is recalling Cios Alpha and Cios Spin mobile X-ray systems because a hardware error could cause permanent loss of imaging functionality.

    Product
    Cios Alpha (VA20) - Model: 10308191 Cios Alpha (VA30) - Model: 11105200 Cios Spin (VA30) - Model: 10308194 Cios Alpha and Cios Spin are a mobile X-Ray system designed to provide X-ray imaging of the anatomical structures of patient during clinical applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2900-2020·2020-09-02

    Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Defect

    Neurovision is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially stopping EMG signal transmission and rendering the device unusable.

    Product
    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2901-2020·2020-09-02

    Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Defect

    Neurovision Medical Products Inc. is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially stopping EMG signal transmission and rendering the device unusable.

    Product
    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKIT-C7-5, RxOnly, Sterile, UDI: B006NvtKITc752/$$7062818C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2898-2020·2020-09-02

    Siemens E.cam and Symbia Systems Recalled for Detector Time Loss

    Siemens Medical Solutions is recalling E.cam and Symbia systems with foresight detectors because they may lose detector time information during gated or dynamic acquisitions.

    Product
    E.cam or Symbia systems that use foresight detectors - Product Usage: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588keV.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2849-2020·2020-09-02

    Conformis iTotal Knee Implant Kit Recalled for Incorrect Contents

    Conformis, Inc. is recalling one iTotal CR Knee Replacement kit because the box contained implants and jigs for a different serial number.

    Product
    Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-2904-2020·2020-09-02

    Neurovision Cobra EMG ET Tube Recalled for Insulating Material Softening

    Neurovision Medical Products Inc. is recalling Cobra x5 1-Ch EMG ET Tubes because the electrode insulating material may soften, potentially damaging the device and stopping signal transmission.

    Product
    Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2899-2020·2020-09-02

    RayCare Oncology Software Recalled for Offline Image Review Error

    RaySearch Laboratories AB is recalling RayCare oncology software due to an error message that may prevent users from accessing offline images during review tasks.

    Product
    RayCare, device is stand-alone software - Product Usage: used to support workflows and scheduling, as well as clinical information, planning and treatment management for oncology care.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2885-2020·2020-09-02

    Canon Medical Ultimax-i Imager Processor Recalled for Image Transfer Errors

    Canon Medical System is recalling 11 Ultimax-i Imager Processors because images transferred to archival systems may not match the number originally acquired.

    Product
    System Model: Ultimax-i, DREX-UI80 (DREX-UI80); Unit Model: HDR-08A Imager Processor; UDI (01)04987670100147
    Category
    Medical Device
    Distribution
    10 states
  • ModerateFDA (Devices)·Z-2905-2020·2020-09-02

    Neurovision Cobra EMG Endotracheal Tubes Recalled for Insulation Softening

    Neurovision is recalling Cobra x5 1-Ch EMG ET Tubes because the electrode insulating material may soften over time, potentially damaging the device and stopping EMG signal transmission.

    Product
    Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: B006LTE700L52$$7061318B - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2889-2020·2020-09-02

    BD SafetyGlide Syringes Recalled for Incorrectly Printed Scale Markings

    Becton Dickinson is recalling 3mL SafetyGlide syringes because the printed scale markings are skewed, missing, or partially printed.

    Product
    BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-2875-2020·2020-09-02

    Ortho-Clinical Diagnostics Recalls VITROS XT Chemistry TBIL-ALKP Slides

    Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry TBIL-ALKP Slides due to potential interference from etrombopag that may affect total bilirubin test results.

    Product
    VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2874-2020·2020-09-02

    Ortho-Clinical VITROS Chemistry BuBc Slides Recalled for Etrombopag Interference

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products BuBc Slides because the drug etrombopag interferes with the test results.

    Product
    VITROS Chemistry Products BuBc Slides - in vitro diagnostic use only. VITROS Chemistry Products BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma, Product code: 8383051 (60 slide); 1612365 (18 slide)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2902-2020·2020-09-02

    Neurovision Nerveana x5 RLN Monitoring Kit Recalled for Insulation Softening

    Neurovision is recalling Nerveana x5 RLN Monitoring Kits because the electrode insulating material may soften, potentially damaging the device and stopping EMG signal transmission.

    Product
    Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2886-2020·2020-09-02

    Match Point System surgical instrument recalled due to incorrect procedure side labeling

    The Match Point System surgical instrument was recalled because the procedure side on planning reports was incorrectly marked as 'Left' instead of 'Right' for right-side procedures.

    Product
    Match Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2877-2020·2020-09-02

    OraSure Benzodiazepine Micro-Plate Recalled for Incorrect Lot Number Labeling

    OraSure Technologies is recalling 13 kits of Interept Benzodiazepine Micro-Plates due to incorrect lot numbers on specification sheets and unit boxes.

    Product
    Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-2876-2020·2020-09-02

    OraSure Benzodiazepine Micro-Plate Recall Due to Incorrect Lot Number Labeling

    OraSure Technologies is recalling 39 kits of the Interept Benzodiazepine Micro-Plate EIA due to incorrect lot numbers on the specification sheet and unit box.

    Product
    Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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