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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14501–14525 of 39988

  • SevereFDA (Devices)·Z-1625-2021·2021-06-02

    Philips Respironics BiPAP V30 Auto Recall for Non-Conforming Plastic Material

    Philips Respironics is recalling 22 BiPAP V30 Auto ventilators because non-conforming plastic in motor assemblies may cause toxic off-gassing or sudden device failure.

    Product
    BiPAP V30 Auto, US market: Continuous ventilator, non-life-supporting. Material Number: 1111178
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1628-2021·2021-06-02

    Philips Respironics BiPAP A40 System Silver Recalled for Motor Assembly Defect

    Philips Respironics is recalling four BiPAP A40 System Silver units due to non-conforming plastic in motor assemblies that may off-gas or fail, posing asphyxia risks.

    Product
    BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: 1111177
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1630-2021·2021-06-02

    Philips Respironics BiPAP A40 Ventilator Recall for Material Defects

    Philips Respironics is recalling four BiPAP A40 ventilators because non-conforming plastic in the motor assembly may cause toxic off-gassing or sudden device failure.

    Product
    BiPAP A40, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111169
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1626-2021·2021-06-02

    Philips Respironics BiPAP A40 Ventilators Recalled for Motor Assembly Defects

    Philips Respironics is recalling 10 BiPAP A40 ventilators due to non-conforming plastic in motor assemblies that may cause toxic off-gassing or sudden device failure.

    Product
    BiPAP A40, China: Continuous ventilator, non-life-supporting. Material Number - CN1111169
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1627-2021·2021-06-02

    Philips BiPAP A40 System Silver Recalled for Motor Assembly Defects

    Philips Respironics is recalling specific BiPAP A40 System Silver units due to non-conforming plastic in motor assemblies that may cause off-gassing or sudden device failure.

    Product
    BiPAP A40 System Silver, JP: Continuous ventilator, non-life-supporting. Material Number: R1111177
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1629-2021·2021-06-02

    Philips Respironics BiPAP A30 Ventilator Recall for Motor Assembly Defect

    Philips Respironics is recalling two BiPAP A30 ventilators due to non-conforming plastic in motor assemblies that may cause toxic off-gassing or sudden device failure.

    Product
    BiPAP A30, Brazil: Continuous ventilator, non-life-supporting. Material Number: BR1111143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2021·2021-06-02

    Radiometer Recalls PICO70 Arterial Blood Samplers Due to Sterile Barrier Breach

    Radiometer is recalling PICO70 Arterial Blood Samplers because a sterile barrier breach was found during testing, posing a risk of bacterial infection.

    Product
    PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyte-balanced, arterial blood sampler product line for collection of arterial samples for pH, blood gas, oximetry, electrolyte and metabolite analysis. Model Number/Product Description: 956-518…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1672-2021·2021-06-02

    Welch Allyn GS777 Wall Transformer Recalled for Electrical Shock Risk

    Welch Allyn is recalling GS777 Wall Transformers due to a potential risk of fluid ingress causing electrical shorts and shock.

    Product
    GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1670-2021·2021-06-02

    Beckman Coulter Access SARS-CoV-2 Antigen Recalled for False Negative Risk

    Beckman Coulter is recalling Access SARS-CoV-2 Antigen test kits because specimens stored in certain conditions may yield false negative results.

    Product
    Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1682-2021·2021-06-02

    Pentax Medical Video Duodenoscope Recalled for Distal End Cap Detachment Risk

    Pentax of America Inc. is recalling 108 Pentax Medical Video Duodenoscopes because the distal end cap may detach during procedures, posing risks of injury or aspiration.

    Product
    Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic access to, Biliary Tract via the Upper Gastrointestinal Tract, Model Number…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1673-2021·2021-06-02

    Welch Allyn ProBP 3400 Digital Blood Pressure Device Recall

    Welch Allyn is recalling ProBP 3400 Digital Blood Pressure Devices due to a risk of fluid ingress causing electrical shorts and potential shock.

    Product
    ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1684-2021·2021-06-02

    Baxter Gambro Cartridge Blood Set Recalled for Potential Leak Risk

    Baxter Healthcare is recalling Gambro Cartridge Blood Sets due to a potential leak between the venous patient connector and the patient's hemodialysis access.

    Product
    Gambro Cartridge Blood Set, Product Code 101025 - Product Usage: intended for single use in a hemodialysis treatment using the Phoenix Dialysis Delivery Systems.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1687-2021·2021-06-02

    James Leckey MyWay Walker Chassis Recalled Due to Weld Failure

    James Leckey Design Ltd is recalling 2,719 MyWay Walker Chassis units because weld failures caused casters to detach from the rear legs.

    Product
    MyWay Walker Chassis - Product Usage: is intended for use by children already using a supportive walking device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1676-2021·2021-06-02

    Dentech Corp. Recalls Rubber Dam Clamps Due to Possible Breakage

    Dentech Corp. is recalling 87,842 units of KSK Rubber Dam Clamps because they may break during use. The recall covers units distributed in the US and worldwide.

    Product
    Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2021·2021-06-02

    Philips IntelliVue MX40 Patient Monitor Recalled for Manufacturing Defects

    Philips is recalling three IntelliVue MX40 patient monitors because manufacturing process failures may have resulted in defective devices.

    Product
    IntelliVue MX40 Patient Monitor, Model Number: 865350 (US) 865352 (OUS) Software version number B.06.59 - Product Usage: Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1679-2021·2021-06-02

    Nobel Biocare Implant Crown Recalled for Manufacturing Specification Defects

    Nobel Biocare Procera LLC is recalling specific implant crown units because they were not manufactured to specification. The recall affects units distributed in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1675-2021·2021-06-02

    Roche Recalls Iron Gen 2 Reagent Cassettes Due to Discrepant Results

    Roche Diagnostics is recalling 20,468 Iron Gen 2 reagent cassettes because they may produce discrepant elevated results on specific analyzers.

    Product
    IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES, Catalog#: 03183696122 - Product Usage: In vitro test for the quantitative determination of iron in human serum and plasma on Roche/Hitachi cobas c and cobas Integra systems.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1681-2021·2021-06-02

    Nobel Biocare Procera LLC Recalls Implant Crowns Not Manufactured to Specification

    Nobel Biocare Procera LLC is recalling specific implant crowns because they were not manufactured to specification. The recall affects units distributed in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC NP CAD 1-25¿ s6 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77387
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1674-2021·2021-06-02

    Siemens Centaur Syphilis Assay Recalled for Potential Carryover Interference

    Siemens Healthcare Diagnostics is recalling the Centaur Syphilis Assay-SYP Kit due to potential carryover into other assays on specific systems.

    Product
    Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualitative determination of antibodies to Treponema pallidum in human serum or plasma using the ADVIA Centaur XP/XPT System and ADVIA Centaur CP Systems, SMN:10492493
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1678-2021·2021-06-02

    Nobel Biocare Procera Implant Crown Recall for Manufacturing Defects

    Nobel Biocare Procera LLC is recalling seven implant crown units because they were not manufactured to specification. The recall covers distribution in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿s3 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77352
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1686-2021·2021-06-02

    CooperSurgical Recalls Incorrectly Packaged Ultem Koh Cup Vaginal Delineators

    CooperSurgical is recalling specific Koh Cup vaginal delineators that were incorrectly packaged with a 3.5cm cup instead of the required 3.0cm model.

    Product
    The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1688-2021·2021-06-02

    Ortho VITROS CoV2 Ag Calibrator Recalled for Calibration Failures

    Ortho-Clinical Diagnostics is recalling 74 units of VITROS CoV2 Ag calibrator (Lot 0020) due to potential unexpected calibration failures.

    Product
    VITROS CoV2 Ag calibrator (Product Code 6199950) - Product Usage: is a chemiluminescent immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal (NP) and anterior nasal swab specimens collected in CDCs formulation of VTM.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1680-2021·2021-06-02

    Nobel Biocare Procera Implant Crown Recalled for Manufacturing Defect

    Nobel Biocare Procera LLC is recalling specific implant crown units that were not manufactured to specification. The recall affects units distributed in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s4 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics. Material Number: 77364
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1677-2021·2021-06-02

    Nobel Biocare Procera Recalls Two Dental Implant Crowns for Specification Defects

    Nobel Biocare Procera LLC is recalling two dental implant crown units because they were not manufactured to specification. The affected units were distributed in the US and several international countries.

    Product
    NPr FCZ¿Imp Crwn ASC CC RP CAD 1-25¿ s2 - Product Usage: Implant Crown intended to be placed in the upper or lower jaw creating a prosthetic device (full contour crown), and to restore the patient s chewing function and esthetics Material Number: 77339
    Category
    Medical Device
    Distribution
    Distributed nationwide