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.

Filters

Agency

All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

11301–11325 of 13717

  • SevereFDA (Devices)·Z-1399-2022·2022-08-17

    FDA Recalls 3.95 Million Viral Transport Containers Distributed Without Clearance

    The FDA recalled 3.95 million viral transport containers distributed without FDA clearance and in violation of established guidance. The containers were distributed worldwide, including to facilities in California, Florida, Illinois, and New York.

    Product
    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Model No. HX-K59-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1485-2022·2022-08-17

    Cobalt Implantable Cardioverter Defibrillators recalled for reduced shock energy

    Medtronic's Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. Patients with affected models should contact their physician.

    Product
    Cobalt Implantable Cardioverter Defibrillators: a. Cobalt XT VR ICD, Model Numbers: DVPA2D1, DVPA2D4; b. Cobalt XT DR ICD, Model Numbers: DDPA2D1, DDPA2D4
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1489-2022·2022-08-17

    Crome Implantable Cardioverter Defibrillators Recalled for Reduced Shock Energy

    Medtronic is recalling 1,657 Crome implantable cardioverter defibrillators due to potential reduced shock energy during high-voltage therapy. Affected devices may deliver only 79% of programmed energy.

    Product
    Crome Implantable Cardioverter Defibrillators: a. Crome VR ICD, Model Numbers: DVPC3D1, DVPC3D4; b. Crome DR ICD, Model Numbers: DDPC3D1, DDPC3D4
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1486-2022·2022-08-17

    Medtronic Cobalt Implantable Defibrillators Recalled Due to Reduced Shock Energy Defect

    Medtronic has recalled 8,429 Cobalt implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) worldwide due to potential reduced shock energy during therapy, potentially delivering 79% of programmed energy.

    Product
    Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt XT HF CRT-D, Model Numbers: DTPA2D4, DTPA2D1; b. Cobalt XT HF Quad CRT-D, Model Numbers: DTPA2QQ, DTPA2Q1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1490-2022·2022-08-17

    Crome Implantable Cardioverter Defibrillators may deliver reduced shock energy

    Medtronic recalls 866 Crome implantable defibrillators due to potential reduced shock energy delivery during high-voltage therapy, affecting devices worldwide. Patients should contact their physician to determine if their device is affected.

    Product
    Crome Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Crome HF CRT-D, Model Numbers: DTPC2D4, DTPC2D1; b. Crome HF Quad CRT-D, Model Numbers: DTPC2QQ, DTPC2Q1
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1487-2022·2022-08-17

    Cobalt Implantable Cardioverter Defibrillators May Deliver Reduced Shock Energy

    Certain Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during therapy, potentially reducing treatment effectiveness. Medtronic is recalling affected units worldwide.

    Product
    Cobalt Implantable Cardioverter Defibrillators: a. Cobalt VR ICD, Model Numbers: DVPB3D1, DVPB3D4; b. Cobalt DR ICD, Model Numbers: DDPB3D1, DDPB3D4
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1400-2022·2022-08-17

    Viral Transport Container Distributed Without FDA Clearance or Guidance Compliance

    Haimen Shengbang Laboratory Equipment recalled 100,000 viral transport containers distributed without FDA clearance and outside FDA guidance, affecting facilities in California, Florida, Illinois, New York, and China.

    Product
    HXBL/WETEX/Genesis Biomedical Viral Transport Container, Custom Made
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1488-2022·2022-08-17

    Cobalt Implantable Defibrillators May Deliver Reduced Shock Energy

    Medtronic Cobalt implantable cardioverter defibrillators may deliver approximately 79% of programmed shock energy during high-voltage therapy. The reduced energy could affect device performance in patients requiring defibrillation.

    Product
    Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D): a. Cobalt HF CRT-D, Model Numbers: DTPB2D4, DTPB2D1; b. Cobalt HF Quad CRT-D, Model Numbers: DTPB2QQ, DTPB2Q1
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1514-2022·2022-08-17

    Lithotripsy Generator Recall Due to Mis-Wired Component Affecting System Reliability

    Olympus Corporation recalls 2 units of the ShockPulse-SE Lithotripsy Generator due to a mis-wired component that causes improper power supply noise and EMC non-compliance, potentially affecting device reliability and treatment delivery.

    Product
    ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1506-2022·2022-08-17

    HAIOU Retractable Safety Syringes Recalled for Needle Detachment Risk

    HAIOU retractable safety syringes are recalled due to reports of needle detachment from the syringe after injection and failure to retract, increasing needle stick injury risk. Approximately 4.05 million units are affected.

    Product
    HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 pieces/box. Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-25G25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2022·2022-08-17

    Aeos Robotic Digital Microscope software errors affect autofocus and rebalancing

    Aesculap is recalling Aeos Robotic Digital Microscopes (versions 2.7 or earlier) due to application errors affecting rebalancing, recovery, and autofocus. Five units were distributed in Arkansas, Indiana, Nebraska, and North Carolina.

    Product
    Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1513-2022·2022-08-17

    Xhibit Telemetry Receiver Model 96280 alarm escalation software defect

    Xhibit Telemetry Receiver Model 96280 units fail to escalate critical alarms after approximately 25 days of continuous use, including signal loss, low battery, and SpO2 sensor issues. Caregivers may not be aware of device failures.

    Product
    Xhibit Telemetry Receiver, Model: 96280
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1509-2022·2022-08-17

    MetaFix hip stem mislabeled with wrong size and batch information

    A Corin MetaFix hip stem (size 7 collarless) was incorrectly labeled as a size 3 collared stem with wrong batch information. The labeling error creates risk during surgical implantation.

    Product
    Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1511-2022·2022-08-17

    GE Healthcare CT, PET, and NM Patient Tables May Drop During Service

    GE Healthcare patient tables used in CT, PET, and NM systems can drop during service if technicians remove incorrect screws without appropriate supports, potentially injuring service personnel.

    Product
    Service manuals for the CT, PET, or NM table as follows: GT1700/GT1700V/VT1700, GT2000/VT2000, GT2000x/VT2000x, High Capacity Table, Lite Table, Kunlun Table, Global PET-CT Table, NP Table, P2005AA Table, LCT Table, CTE TWIN TABLE Assy. All devices are patient tables for PET/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1515-2022·2022-08-17

    Roche cobas e801 Analyzer Recall: Software Defect Affects Test Results

    Roche is recalling approximately 965 cobas e801 Immunoassay Analyzers nationwide due to a software issue that impacts Pre-Wash test signals and results for six diagnostic assays. No injuries or illnesses have been reported.

    Product
    cobas e801 Immunoassay Analyzer
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1510-2022·2022-08-17

    FDA Recalls 3D Systems VSP Scapula Marking Guide Due to Design Defect

    Medical Modeling, Inc. is recalling the 3D Systems VSP Reconstruction Scapula Marking Guide (Model VSPR-301) because it was incorrectly designed. The device was distributed internationally, including to Germany.

    Product
    3D Systems VSP Reconstruction, Model: VSPR-301 Product: Scapula Marking Guide (Anatomically Shaped), Rx Only, Non-Sterile
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1507-2022·2022-08-17

    Haiou Needle Retractable Safety Syringe recalls due to needle detachment risk

    Approximately 7,218,000 Haiou Needle Retractable Safety Syringes are being recalled due to needle detachment and retracting mechanism failures that increase needlestick injury risk. The affected product was distributed in California.

    Product
    Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Use: Disposable sterile needle retractable safety syringe. Catalog Number: NRSS1-23G25
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1508-2022·2022-08-17

    Cholestech LDX cholesterol test cassettes require bilirubin interference label update

    Alere is updating the package insert for Cholestech LDX cholesterol test cassettes to disclose that samples with elevated bilirubin can produce inaccurate triglyceride and HDL results. Approximately 436,990 units are affected.

    Product
    The Cholestech LDX¿ System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or
    Category
    Medical Device
    Distribution
    31 states
  • SevereFDA (Devices)·Z-1401-2022·2022-08-10

    SARS-CoV-2 Rapid Antigen Test Kits Distributed Without FDA Approval

    North American Diagnostics is recalling SARS-CoV-2 rapid antigen test kits that were distributed without FDA approval or clearance. Approximately 122,366 units were sold to consumers across multiple US states and internationally.

    Product
    SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished Kits, SML Brand BT Test Kits, SML Brand BT Antigen Test Kit LDT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1442-2022·2022-08-10

    NanoSight NS300 Medical Device Recalled for Laser Safety Noncompliance

    Malvern Panalytical is recalling 507 NanoSight NS300 units due to noncompliance with Class 1 laser safety requirements. The device may not meet established safety standards for laser-based instruments.

    Product
    NanoSight NS300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1502-2022·2022-08-10

    UroLift System recalled for potential implant deployment failure

    Neotract Inc is recalling 18,722 UroLift Systems due to potential improper implant deployment during use. Patients should contact their healthcare provider.

    Product
    UroLift System REF UL400-4, QTY 4 Urolfit System with Handle Release Tool
    Category
    Medical Device
    Distribution
    45 states
  • HighFDA (Devices)·Z-1496-2022·2022-08-10

    Merlin 2 PCS MER3400 programmer software recalled by St. Jude Medical

    St. Jude Medical recalled Merlin 2 PCS MER3400 programmer software version 1.1.2 revision 1 or earlier in an FDA Class II recall. The recall affects 622 units distributed across the United States and internationally.

    Product
    Merlin 2 PCS MER37000 programmer Model MER3400 software
    Category
    Medical Device
    Distribution
    53 states
  • HighFDA (Devices)·Z-1484-2022·2022-08-10

    E-100 Generator electrosurgical units recalled due to preventative maintenance oversight

    Intuitive Surgical is recalling 505 E-100 electrosurgical generators because required preventative maintenance was not performed on units distributed worldwide and in the US.

    Product
    The E-100 Generator (PN 374848-09) is a bipolar electrosurgical unit (ESU) designed to be used with the da Vinci Xi and X systems. The E-100 is installed on the Vision Cart and is connected to the system. The functions of the E-100 are initiated by the foot pedals on the Surgeon
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1495-2022·2022-08-10

    Pacemaker Programmer Software May Display Overestimated Battery Longevity

    St. Jude Medical's Merlin PCS 3650 programmer software may display overestimated predicted battery longevity for certain pacemakers. This could affect clinical decision-making regarding device maintenance and replacement timing.

    Product
    Merlin PCS 3650 programmer Model 3330 software
    Category
    Medical Device
    Distribution
    53 states