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 deaths or serious injuries are reported, 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

11726–11750 of 13748

  • HighFDA (Devices)·Z-1100-2022·2022-05-25

    Affinity Dental Impression Material Recalled for Wrong Material

    Clinician's Choice Dental Products is recalling Affinity Hydroactive Impression Material Heavy Body Regular Set because Template Ultra Quick matrix Material was packaged instead of the indicated Heavy Body viscosity. The recall affects 46 units distributed in South Carolina.

    Product
    Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1114-2022·2022-05-25

    VITROS Prolactin Reagent Recalled for Low-End Measurement Imprecision

    Ortho-Clinical Diagnostics is recalling VITROS Prolactin Reagent packs due to low-end measurement imprecision that may cause falsely high or delayed test results. Approximately 1,767 affected units are distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1092-2022·2022-05-25

    Verigene Processor heating system may produce false negative results

    Luminex Corporation is recalling 24 Verigene Processor SP units because the heater may operate outside established temperature limits, potentially producing false negative diagnostic results.

    Product
    Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1087-2022·2022-05-25

    MicroScan WalkAway-40 Medical Instruments Recalled for Incorrect Power Connector Rating

    Three MicroScan WalkAway-40 medical instruments were recalled because they have an AC power connector rated at 1 ampere instead of the correct 10 ampere rating. This mismatch poses a potential electrical and fire hazard.

    Product
    MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1091-2022·2022-05-25

    ATLAS Stim Headbox Recalled: Unapproved Investigational Device Without Safety Testing

    Neuralynx is recalling the ATLAS Stim Headbox, a neurophysiology device distributed without FDA investigational approval or electrical safety clearance.

    Product
    ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2022·2022-05-25

    HeartWare Ventricular Assist Device recalled for translation errors

    Heartware, Inc. is recalling the HeartWare Ventricular Assist Device (HVAD) in Finland and Turkey due to translation errors in device displays and supporting documentation that could impair proper device operation.

    Product
    HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1116-2022·2022-05-25

    Olympus Uretero-reno Videoscope Bending Section May Crack and Deform

    The bending section of the Olympus URF-V2 videoscope may crack and develop abnormal shape or angulation. This could affect the device's function during urological procedures.

    Product
    Olympus Uretero-reno videoscope, Model No. URF-V2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2022·2022-05-25

    HeartWare Ventricular Assist Device controller has translation errors in Finnish, Turkish

    HeartWare Ventricular Assist Device controllers in Finland and Turkey contain translation errors in displays, instructions, and patient manuals. The errors could affect proper device operation and emergency response.

    Product
    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1096-2022·2022-05-25

    BioPlex 2200 CMV IgM Reagent Pack Recalled for Variable Test Performance

    Bio-Rad Laboratories recalls the BioPlex 2200 ToRC IgM Reagent Pack (Lot 301388) due to CMV IgM analyte showing variable elevated background levels depending on reagent handling.

    Product
    BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1078-2022·2022-05-25

    Getinge Washer Disinfector models recalled for inadequate installation documentation

    Getinge USA is recalling 127 Washer Disinfector models worldwide due to inadequate documentation verifying proper installation. The issue could lead to installation failures and potentially hazardous situations.

    Product
    Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
    Category
    Medical Device
    Distribution
    34 states
  • ModerateFDA (Devices)·Z-1110-2022·2022-05-25

    Documentation errors recalled in HeartWare HVAD instructions and manuals

    Medtronic is recalling instruction materials for the HeartWare HVAD ventricular assist device due to errors and inconsistencies in product documentation.

    Product
    Instructions for Use, Patient Manuals, and Emergency Responder Guides for HeartWare Ventricular Assist Device (HVAD) System. HVAD System. IFUs are distributed as part of the Pump Implant Kits models: 1103, MCS1705PU, 1104, and 1104JP. Additionally, IFUs, ERGs, and PMs are dist
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1109-2022·2022-05-25

    VERIGENE extraction tray reagent defect causes test control failures

    Luminex Corporation is recalling a lot of VERIGENE Nucleic Acid Test Kit extraction trays due to missing reagent causing increased internal control failures. Affected lot: 101321021B, 984 units distributed in the US.

    Product
    VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1101-2022·2022-05-25

    Medical Device Swabs Recalled Due to Manufacturing Validation Uncertainty

    Convenience kits containing Prevantics swabs used in medical procedures are being recalled because the manufacturer failed to adequately validate the manufacturing test methods used during production.

    Product
    Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biopsy Pack (24771)/AMS6572A, Bone Marrow Pack (11862)/AMS6573,
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1097-2022·2022-05-25

    Randox CK MB Calibrator recalled due to calibration inaccuracy affecting test results

    Randox Laboratories has recalled the CK MB Calibrator (lot 4410CK) because it requires recalibration. When used without proper realignment, the calibrator produces test results approximately 6% higher than actual values.

    Product
    CK MB Calibrator, Catalogue Number CK2393
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1080-2022·2022-05-25

    EXALT Model D Single-Use Duodenoscope Updated Guidance on Perforation Risk

    Boston Scientific updated instructions for the EXALT Model D Single-Use Duodenoscope to address the known risk of duodenal perforation and provide best clinical practices for proper insertion, advancement, and removal of the device.

    Product
    EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1103-2022·2022-05-25

    HeartWare HVAD System Controller Recalled for Translation Errors in Documentation

    Heartware is recalling 667 units of the HVAD System Controller (Model 1407DE Kit) due to translation errors in Finnish and Turkish in controller and monitor displays, as well as user documentation, which could affect patient understanding and emergency responder guidance.

    Product
    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1081-2022·2022-05-25

    EXALT Model D Duodenoscope Updated Instructions Address Known Perforation Risk

    Boston Scientific is updating instructions for the EXALT Model D Single-Use Duodenoscope to highlight the known risk of perforation during use and provide best clinical practices for insertion, advancement, and removal.

    Product
    EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1090-2022·2022-05-25

    Total Resources International First Aid Kits Recalled Due to Cross-Contamination Risk

    Total Resources International is recalling 891 First Aid Kits due to a potential cross-contamination issue from a manufacturing equipment breach. The kits contain electrolyte tablets that may have been exposed to pharmaceutical contaminants below therapeutic dose levels.

    Product
    Total Resources International First Aid Kits, Item Numbers: 01REF2621, 10OUT02086REV3. Kit contents include ULTRAtab Laboratories Electrolyte Tablets under the Brand of Medique and Medi-Lyte, Product Code: M963.
    Category
    Medical Device
    Distribution
    30 states
  • SevereFDA (Devices)·Z-1009-2022·2022-05-18

    FDA Recalls Accula SARS-CoV-2 Test for False Positive Risk

    Mesa Biotech is recalling approximately 6,162 units of the Accula SARS-CoV-2 Test due to an increased risk of false positive results, which could delay correct diagnosis and treatment.

    Product
    Accula SARS-CoV-2 Test, REF: COV4100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1045-2022·2022-05-18

    COVID-19 Antigen Test Kit Distributed Without FDA Authorization or Clearance

    The FDA is recalling 17,000 units of Joysbio SARS-CoV-2 Antigen Rapid Test Kits distributed in Alabama and Georgia. The tests were sold without FDA clearance or authorization for marketing in the United States.

    Product
    Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1044-2022·2022-05-18

    COVID-19 Rapid Antigen Test Kits Recalled for Unauthorized Distribution

    Woodside Acquisitions Inc. recalled 34,240 Oral Rapid SARS-CoV-2 Antigen Test Kits distributed in Alabama and Georgia. The tests were distributed without FDA clearance or authorization for marketing.

    Product
    Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1042-2022·2022-05-18

    Medtronic IN.PACT Admiral balloon catheters recalled for damaged packaging

    Medtronic is recalling IN.PACT Admiral paclitaxel-coated balloon catheters due to damaged packaging that may result in loss of sterility, affecting approximately 6,035 units worldwide.

    Product
    Medtronic IN.PACT Admiral, Paclitaxel-coated PTA Balloon Catheter, Sterile EO, Rx Only for the following model Numbers:ADM04004013P ADM04008013P ADM04008013P ADM04008013P ADM04012013P ADM04015013P ADM04015013P ADM04025013P ADM05004013P ADM05004013P ADM05006013P ADM05006013P ADM05
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1062-2022·2022-05-18

    CMOS Video Cysto-Urethroscope Disinfection Failure Puts Patients at Infection Risk

    Karl Storz Endoscopy is recalling CMOS Video Cysto-Urethroscope devices because they fail to achieve adequate microbial reduction during disinfection, creating infection risk.

    Product
    11272V CMOS VIDEO-CYSTO-URETHROSCOPE REV 11272VA 11272VAK CMOS VIDEO-CYSTO-URETHROSCOPE REV; 11272VU 11272VUK CMOS VIDEO-CYSTO-URETHROSCOPE US; 11272VUA 11272VUAK CMOS VIDEO-CYSTO-URETHROSCOPE US
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1068-2022·2022-05-18

    Karl Storz Video Ureteroscopes May Not Be Properly Sterilized

    Karl Storz ureteroscopes and flexible video ureteroscopes may fail to achieve adequate sterilization during the disinfection process, potentially leaving microorganisms on the devices that could cause patient infections.

    Product
    11278V 11278VK CMOS Video Ureteroscope Z17744US-A (04/2016); 11278VA 11278VAK Flexible Video-Uretero-Renoscope (FLEX-XC) Z23117US-BA (10/2020); 11278VU 11278VUK Flexible Video-Uretero-Renoscope (FLEX-XC) Z18447US-BC (03/2018); 11278VUA 11278VUAK Flexible Video-Uretero-Renoscop
    Category
    Medical Device
    Distribution
    51 states