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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11376–11400 of 27470

  • HighFDA (Devices)·Z-2000-2021·2021-07-14

    Accolade Pacemakers Recalled for Hydrogen-Related Battery Depletion

    Boston Scientific is recalling Accolade pacemaker models L300, L301, L310, L311, L321, and L331 due to latent hydrogen release that compromises the capacitor and accelerates battery depletion.

    Product
    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2038-2021·2021-07-14

    Angiography and Cesarean Birth Drapes recalled due to sticking defect

    Cardinal Health is recalling Nonsterile Femoral Angiography and Cesarean Birth Drapes (15,360 units) because plastic film causes sticking that may prevent proper unfolding and application.

    Product
    Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1952-2021·2021-07-07

    LeadCare II Blood Lead Test Kit Control Test Inaccuracy Recall

    The LeadCare II Blood Lead Test Kit may generate artificially low control test results, causing blood lead levels to be underestimated in patient samples. Kits were distributed worldwide.

    Product
    LeadCare II Blood Lead Test Kit Catalog Number 70-6762
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1953-2021·2021-07-07

    Blood Lead Test Kit Recalled for Inaccurate Control Test Results

    Magellan Diagnostics recalls LeadCare Plus Blood Lead Test Kit after control tests generated low results, potentially underestimating patient blood lead levels. Affected lot numbers include 2011MU, 2104MU, and 2108MU.

    Product
    LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1954-2021·2021-07-07

    LeadCare Ultra Blood Lead Test Kit Recalled for Control Test Inaccuracy

    Magellan Diagnostics is recalling the LeadCare Ultra Blood Lead Test Kit due to control test failures causing potential underestimation of blood lead levels in patient samples. The recall involves 441 kits with worldwide distribution.

    Product
    LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1993-2021·2021-07-07

    Percutaneous Dilation Tracheostomy Kit Recalled for Incorrect Size Labeling

    One lot of PORTEX ULTRperc Percutaneous Dilation Tracheostomy Kit (Lot 4072715) was incorrectly labeled as 7.0mm when it is 9.0mm. The 40 units were distributed in Pennsylvania, Michigan, Maryland, and Florida.

    Product
    PORTEX UNLTRperc Percutaneous Dilation Tracheostomy Kit, REF 100/596/090 - Product Usage: intended for use in a controlled setting such as an Intensive Care Unit or operating room with the assistance of trained personnel.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1982-2021·2021-07-07

    Monitor Bracket Assembly Fall Hazard Recall Affects Multiple CT Systems

    Philips is recalling 1,301 monitor bracket assemblies used with CT systems due to shaft wear that could cause monitors to fall, potentially injuring patients, operators, bystanders, or service personnel.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 64, Brilliance 40, Ingenuity Flex 728235 - Brilliance 40 728231/728232 - Brilliance 64 728317/728318 - Ingenuity Flex
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1987-2021·2021-07-07

    Philips CT Monitor Bracket May Detach Due to Shaft Wear

    Philips CT fluoroscopy monitors may develop bracket shaft wear that could lead to the monitor detaching and falling while attached to cables.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882442/882456 - Ingenuity TF PET/CT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1955-2021·2021-07-07

    Synaptive Suction Sets Recalled for Metal Burrs on Tube Interior

    Synaptive Medical is recalling 1,291 Trackable Suction Sets for visible metal burrs and filings along the inner suction tube. The defect may contaminate the surgical field or cause injury.

    Product
    Synaptive Trackable Suction Set Standard and Malleable
    Category
    Medical Device
    Distribution
    15 states
  • HighFDA (Devices)·Z-1975-2021·2021-07-07

    PERLA TL Lateral Connector Open Spinal Fusion Devices Recalled for External Label Error

    SPINEART SA is recalling 44 units of PERLA TL Lateral Connector Open spinal fusion connectors distributed in the U.S. due to external labels that incorrectly list the rod size.

    Product
    PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1979-2021·2021-07-07

    Philips CT Monitor Bracket Assembly risks ceiling fall hazard

    Philips is recalling 1,301 Monitor Bracket Assemblies used in CT and PET/CT imaging systems worldwide due to potential shaft wear that could cause the monitor to detach from the ceiling mount and fall, posing injury risk.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems: Model - MX8000 Models: 728120/728125/728201
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1964-2021·2021-07-07

    Edwards TruWave Pressure Monitoring Set Recalled for Potential Tubing Detachment

    Edwards Lifesciences is recalling 990 units of the Edwards TruWave (30 cc)/VAMP Jr Kit pressure monitoring set because the pressure tubing may detach from the blood sampling system. Healthcare facilities should discontinue use.

    Product
    Edwards TruWave (30 cc)/VAMP Jr Kit, REF: VMP306PX, Pressure Monitoring Set, Rx Only, CE, UDI: (01)57460691950370
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1984-2021·2021-07-07

    Philips CT Monitor Bracket Assembly May Detach and Fall

    Philips is recalling 1,301 monitor bracket assemblies for CT imaging systems due to shaft wear that could cause detachment and fall of the monitor. This could result in serious injury to patients, operators, and staff.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Ingenuity Core, Ingenuity Core 128, Ingenuity CT 728321 - Ingenuity Core 728323 - Ingenuity Core 128 728326/728327 - Ingenuity CT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1976-2021·2021-07-07

    Medtronic Endurant II Stent Graft System Recalled for Incorrect Assembly

    Medtronic is recalling 3 Endurant II/IIs Stent Graft Systems due to an incorrect stentstop assembly component in the delivery system. The defective devices use an 18-French assembly instead of the required 20-French component.

    Product
    Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II BIF. For treatment of vascular aneurysms.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1990-2021·2021-07-07

    Monitor Bracket Assembly Shaft Wear Risk in Philips CT Fluoroscopy Systems

    Philips CT fluoroscopy monitor brackets may detach from suspension arms due to unrecognized shaft wear, risking the monitor falling and causing serious injury to patients, operators, or bystanders.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728306 - Brilliance iCT 728311 - Brilliance iCT SP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1971-2021·2021-07-07

    Tripolar Hooked Stimulation Probes recalled for ethylene oxide sterilization deviation

    Spes Medica is recalling Tripolar Hooked Stimulation Probes due to possible deviations in the ethylene oxide sterilization process. The affected devices were distributed to healthcare facilities in California, Massachusetts, and South Carolina.

    Product
    Tripolar Hooked Stimulation Probes, L=20mm, Reference Number SI3H0020S2526D. Used during intraoperative neurological monitoring.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1978-2021·2021-07-07

    NeuMoDx Cartridge Recall: Risk of False Positive Diagnostic Results

    NeuMoDx Molecular Inc. is recalling certain cartridge lots that may produce false positive diagnostic results. Affected healthcare providers should verify tests performed with these cartridges and contact the manufacturer for guidance.

    Product
    NeuMoDx Cartridge, For In Vitro Diagnostic Use on the NeuMoDx 288 and NeuMoDx 96 Molecular Systems, Model Number 100100
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1965-2021·2021-07-07

    Pressure monitoring set recalled for potential pressure tubing detachment

    Edwards Lifesciences is recalling the TruWave 3 cc/VAMP Jr pressure monitoring set (Lot #63598812) due to a potential risk that the pressure tubing may detach from the blood sampling system.

    Product
    Edwards TruWave 3 cc/VAMP Jr Kit, REF: VMP426PX, Pressure Monitoring Set, Rx Only, CE UDI: (01)57460691950547
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1969-2021·2021-07-07

    Dragonfly Laryngeal Electrode Recalled Due to Sterilization Process Issues

    Spes Medica is recalling Dragonfly Laryngeal Surface Electrodes due to possible deviations in ethylene oxide sterilization parameters. The affected lots are LS20E2538I and 110320C, distributed to select US states.

    Product
    Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1983-2021·2021-07-07

    CT Monitor Bracket Assembly Recalled Due to Shaft Wear and Detachment Risk

    Philips North America is recalling CT system monitor bracket assemblies due to shaft wear that could cause the bracket to detach from the suspension arm, potentially allowing the monitor to fall and cause serious injury.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. BB (Big Bore) Oncology, BB (Big Bore) Radiology: 728242/728243/728244/728272 - Brilliance Big Bore
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1988-2021·2021-07-07

    Philips Monitor Bracket Assembly falls due to shaft wear in medical imaging systems

    Philips monitor bracket assemblies for CT/PET imaging systems may detach due to shaft wear, posing a risk of the monitor falling and causing serious injury to patients, operators, or bystanders.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 882446 - Vereos PET/CT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1996-2021·2021-07-07

    Infusion Pump Order Form Discontinued Due to Ambiguous Reuse Instructions

    Flowonix Medical is recalling physician order forms for Prometra infusion pumps due to ambiguous wording that could be misinterpreted as instructions to reuse previously extracted medication, posing an infection risk.

    Product
    Physician Order Form (PL-15400-00, Nov. 2018) distributed to end user used with the following: Prometra Programmable Infusion Pump System: MODEL/CATALOG #(s): Catalog No. US Model GTIN-14 11827 Prometra Programmable…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1959-2021·2021-07-07

    Edwards TruWave Pressure Monitoring Set Recalled for Potential Tubing Detachment

    Edwards Lifesciences is recalling its pressure monitoring set due to potential tubing detachment. Approximately 460 units distributed across North America and Europe are affected.

    Product
    Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507
    Category
    Medical Device
    Distribution
    33 states
  • HighFDA (Devices)·Z-1977-2021·2021-07-07

    Exactech Humeral Augmented Tray orthopedic implant components recalled for disengagement risk

    Exactech is recalling Humeral Augmented Tray (HAT) orthopedic implant components because the retaining ring may disengage during use. The recall affects 36 devices distributed in six U.S. states.

    Product
    Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following catalog numbers for a total of 6 trials/tray: (1) HAT STD Left Tray Trial, Cat. #321-00-01; (2) HAT STD Right Tray Trial, Cat. #321-00-02; (3) HAT LAT Left…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1962-2021·2021-07-07

    Blood Management System Pressure Tubing May Detach

    Edwards Lifesciences blood management system (VJ0990) pressure tubing may detach from the blood sampling system during use. The recall affects 2,000 units distributed across the U.S., Canada, UK, and Italy.

    Product
    Edwards REF: VJ0990, Blood Management System, Rx Only, Single Use, CE, Sterile EO UDI: (01)57460691951520
    Category
    Medical Device
    Distribution
    33 states