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)

Clear filters

16626–16650 of 27500

  • HighFDA (Devices)·Z-0302-2019·2018-11-07

    Philips Recalls Vereos PET/CT Software Due to Image Errors

    Philips Medical Systems is recalling 61 units of Vereos PET/CT software version 2.0.1 due to errors that may produce incorrect images or disrupt procedures.

    Product
    Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2019·2018-11-07

    Philips Ingenuity CT Software Recall for Misleading Calcium Score Reports

    Philips is recalling Ingenuity CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.

    Product
    Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0312-2019·2018-11-07

    BD Max Instrument Reader Spare Part Recalled for False Positive Results

    Becton Dickinson is recalling 23 BD Max Instrument Reader Spare Parts due to a confirmed trend of false positive Candida glabrata results.

    Product
    BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0295-2019·2018-11-07

    Arthrex Recalls Li-ion Battery Housings for AR-400 DrillSaw Sports 400 System

    Arthrex, Inc. is recalling 335 Li-ion Battery Housings for the AR-400 DrillSaw Sports 400 System because they may not provide a complete seal, allowing for potential fluid ingress.

    Product
    Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0285-2019·2018-11-07

    Magellan LeadCare II Blood Lead Test Kit Recalled for Calibration Defect

    Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because a calibration defect causes all patient results to display as HIGH.

    Product
    Magellan LeadCare¿ II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is for in vitro diagnostic use only. The test kit is for the quantitative…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2019·2018-11-07

    Philips CT Scanner Software Recall for Misleading Calcium Score Reports

    Philips is recalling Ingenuity Core CT scanners with software version 4.1.6 because the Calcium Score report may display confusing plaque analyses, potentially leading to patient mistreatment.

    Product
    Ingenuity Core (Model No. 728321), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2019·2018-11-07

    CMP Industries Recalls Dental Resin Liquid Due to Foreign Material

    CMP Industries is recalling specific lots of Impak Elastic Acrylic Resin Liquid because foreign material was found in the product.

    Product
    IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0361-2019·2018-11-07

    Inpeco FlexLab and Accelerator a3600 Recalled for Missing Safety Labels

    Inpeco S.A. is recalling 679 laboratory automation systems because some modules are missing safety pacemaker labels. The recall addresses a risk of pacemaker malfunction for personnel working near the equipment.

    Product
    FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2) (same product) FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre- Analytical and Post-Analytical processing,
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-0188-2019·2018-10-31

    Alcon Recalls CyPass Micro-Stent Implant Due to Endothelial Cell Loss

    Alcon is recalling the CyPass Micro-Stent implant because long-term study data showed statistically significant endothelial cell loss in patients who received the device.

    Product
    CyPass System 241, Intraocular Pressure Lowering Implant, CYPASS MICRO-STENT, CYPASS APPLIER, REF: 8065754010. For ophthalmic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0243-2019·2018-10-31

    CHS Cotton Tip Applicators Recalled Due to Sterility Compromise

    Custom Healthcare Systems is recalling 150 units of CHS Cotton Tip Applicators because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B
    Category
    Medical Device
    Distribution
    9 states
  • SevereFDA (Devices)·Z-0202-2019·2018-10-31

    Boston Scientific Recalls Maestro 4000 Cardiac Ablation Systems Due to RF Energy Issue

    Boston Scientific is recalling Maestro 4000 Cardiac Ablation Systems because radiofrequency energy may continue to deliver after the foot switch is released.

    Product
    Boston Scientific Maestro 4000 Cardiac Ablation System, Firmware Version 5.14, Model Numbers: M00440000, M0044000D0, M0044000H0,M0044000R0, M0044000Z0,
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-0236-2019·2018-10-31

    GE Medical Systems Recalls Signa Architect MRI Scanners Due to Burn Risk

    GE Medical Systems is recalling four Signa Architect MRI scanners because a small area on the bore surface can get warm enough to cause a serious burn if proper padding is not used.

    Product
    SIGNA Architect system Product Usage: The Signa Architect system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0198-2019·2018-10-31

    Bovie J-Plasma Precise 360 Handpiece Recalled for Tip Separation Risk

    Bovie Medical Corporation is recalling J-Plasma Precise 360 handpieces because the PEEK tip may separate and remain in patient tissue.

    Product
    J-Plasma Precise 360, single use, disposable. The Bovie J-Plasma Precise 360 Handpiece is used for the delivery of helium gas plasma for cutting, coagulation, and ablation of soft tissue during open and laparascopic surgical procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0185-2019·2018-10-31

    Alcon Recalls CyPass Micro-Stent Due to Endothelial Cell Loss

    Alcon Research is recalling CyPass Micro-Stent devices because long-term study data showed statistically significant endothelial cell loss in patients.

    Product
    CyPass System 241-S, CYPASS MICRO-STENT, CYPASS LOADED, CYPASS APPLIER, REF CATALOG #: 8065754003 For ophthalmic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0214-2019·2018-10-31

    Siemens APTIO Rack Output Module Recall for Missing Warning Label

    Siemens Healthcare Diagnostics is recalling 441 APTIO Rack Output Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    APTIO RACK OUTPUT MODULE
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0187-2019·2018-10-31

    Alcon Recalls CyPass Micro-Stent Due to Endothelial Cell Loss

    Alcon Research is recalling the CyPass Micro-Stent because long-term study data showed statistically significant endothelial cell loss in patients who received the device.

    Product
    CyPass ULTRA SYSTEM, CYPASS MICRO-STENT, CYPASS APPLIER, REF CATALOG #: 8065754007. For ophthalmic use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0276-2019·2018-10-31

    Medtronic O-arm 1000 2nd Edition Imaging System Software Recall

    Medtronic is recalling O-arm 1000 2nd Edition Imaging Systems due to software anomalies affecting startup, communication, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, BASE BASE OARM Bl70000027120R SYSTEM 120V RWK, Model Number Bl70000027120R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0205-2019·2018-10-31

    ESAOTE MyLab Gamma Ultrasound System Recalled for Probe Overheating Risk

    ESAOTE S.P.A. is recalling 10 MyLab Gamma, Model 7410 ultrasound systems because probe power monitoring settings may cause the probe head to overheat during continuous operation.

    Product
    MyLab Gamma, Model 7410
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0246-2019·2018-10-31

    CHS Custom Convenience Kit-PAD recalled for compromised sterility

    Custom Healthcare Systems is recalling 160 units of CHS Custom Convenience Kit-PAD, COTTON SINGLE because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-PAD, COTTON SINGLE Product Number:R1178
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-0210-2019·2018-10-31

    Siemens APTIO Rack Input Module Recall for Missing Pacemaker Warning

    Siemens Healthcare Diagnostics is recalling 441 APTIO Rack Input Modules because they may have been shipped without a warning label regarding potential interference with pacemaker functionality.

    Product
    APTIO RACK INPUT MODULE
    Category
    Medical Device
    Distribution
    38 states
  • HighFDA (Devices)·Z-0272-2019·2018-10-31

    Medtronic Recalls O-arm 1000 2nd Edition Imaging Systems Due to Software Anomalies

    Medtronic is recalling 596 O-arm 1000 2nd Edition Imaging Systems worldwide due to reported software anomalies affecting startup, motion control, and image acquisition.

    Product
    O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027R SYS PRODUCT RWK, Model Number Bl70000027R Product Usage: The O-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D…
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-0208-2019·2018-10-31

    DePuy Mitek Screw and Washer Depth Gauge Recalled for Design Offset

    DePuy Mitek is recalling 401 Mitek Screw and Washer Depth Gauges because a design offset causes readings to be approximately 3.2mm shorter than the actual bone hole length.

    Product
    Mitek Screw and Washer Depth Gauge, Product Code 219024
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0241-2019·2018-10-31

    Custom Healthcare Systems Recalls Injection Trays Due to Sterility Compromise

    Custom Healthcare Systems is recalling 40 units of CHS Custom Convenience Kit-INJECTION TRAY because incorrect sealing specifications compromised product sterility.

    Product
    CHS Custom Convenience Kit-INJECTION TRAY Product Number: B9-17201
    Category
    Medical Device
    Distribution
    9 states