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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

4876–4900 of 13543

HighFDA (Devices)·Z-0055-2025·2024-10-16
Enterprise Imaging XERO Viewer medical software reference line placement error
Enterprise Imaging XERO Viewer incorrectly displays reference lines on medical images due to a software defect affecting images with non-square pixel spacing. The misplaced reference lines may lead to diagnostic errors.
Product
Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data . Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8.1, 8.1.1, 8.1.2, 8.1.3,8.1.4, 8.2.0.000, 8.2.1.000, 8.2.2.000, 8.3.0.000, 8.3.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0021-2025·2024-10-16
Trevo Trak 21 Microcatheter Distributed with Incorrect Instructions and Labels
Stryker Neurovascular is recalling Trevo Trak 21 Microcatheters because Out-of-US approved instructions and labels were distributed instead of US-approved versions. Affected customers in CA and VA should contact the manufacturer.
Product
The Trevo Trak 21 Microcatheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque marker(s) on the distal end and a luer hub on the proximal end. The catheter shaft has a hydrophilic coating on the distal 100cm to reduce friction during use. The radiop
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0051-2025·2024-10-16
Endoscopy and Bronchoscopy Systems Power Cord Defect Risk
Monarch Platform endoscopy and bronchoscopy systems may have defective power cords causing electrical shorts and shock risk if exposed wires are touched, potentially leading to system shutdown.
Product
Monarch Platform (Endoscopy), REF: MON-000005-01, MON-000005-01R. Monarch Platform (Bronchoscopy), REF: MON-000006, MON-000006-RFB.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0026-2025·2024-10-16
BD Synapsys Laboratory Software May Display Incorrect Antibiotic Susceptibility Results
BD Synapsys Informatics Solution versions 4.20–5.30 contain a software error that may incorrectly display antibiotic susceptibility results, potentially leading to inadequate or prolonged antibiotic treatment.
Product
BD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and 5.30- IVD standalone laboratory software solution providing data management and workflow management functionality across locations where clinical diagnostic activities take place. Catalog Number
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0020-2025·2024-10-16
Philips IntelliVue Patient Monitor Software Configuration Disables Enhanced ECG Alarms
Philips patient monitors with Option CP2 software version P.01.01 were factory-configured incorrectly, leaving enhanced arrhythmia detection alarms disabled. Affected devices will not trigger yellow alarms for enhanced arrhythmia detection.
Product
IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indica
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0054-2025·2024-10-16
MEDIHONEY Dressing Applicator Pouch Recalled for Sterility Concerns
Integra LifeSciences recalls MEDIHONEY Dressing applicator pouches due to potential pinholes that may compromise sterility. The recall affects approximately 120,124 units distributed across 36 US states and internationally.
Product
MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR, 1.5oz tube (Model Number 31515) and 3.5oz tube (Model Number 31535)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0022-2025·2024-10-16
FastPack TSH Calibrator Kit Recalled Due to Incorrect Barcode
Qualigen Inc is recalling the FastPack TSH Calibrator Kit due to an incorrect barcode linked to incorrect information. The barcode defect may allow successful system calibration, but TSH test results obtained could be higher than expected.
Product
FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-0039-2025·2024-10-16
GE Healthcare Centricity Universal Viewer may fail to display latest diagnostic report
GE Healthcare Centricity Universal Viewer Zero Footprint Client version 6.0 SP11.x may fail to show the latest diagnostic report by default when a study contains multiple DICOM structured reports in different series.
Product
GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129; c)¿¿¿¿¿ 2089507-131; d)¿¿¿¿ 2089507-135; e)¿¿¿¿ 2089507-136; f)¿¿¿¿¿¿ 2089507-140; g)¿¿¿¿¿ 2089507-144; h)¿¿¿¿ 2089507-145; i)¿
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0023-2025·2024-10-16
Knee Replacement Implant Recalled for Out-of-Spec Locking Tabs
The FDA is recalling the Triathlon Universal TS Baseplate Size 2 knee implant due to defective locking tabs that may not properly engage with the tibial insert, potentially causing implant failure.
Product
Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0033-2025·2024-10-16
Medline Blood Pressure Monitor Recalled for Microchip Failure and Overheating
Medline is recalling approximately 9,608 automatic digital blood pressure units due to a faulty microchip that causes power failures, display issues, and overheating.
Product
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0038-2025·2024-10-16
3M Tegaderm CHG I.V. Dressing Recalled for Foreign Contamination
3M is recalling Tegaderm CHG I.V. Securement Dressing (REF 1658R) due to contamination with foreign substance matter. The affected lot (33WWRRR) was distributed to South Korea.
Product
3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0045-2025·2024-10-16
Check-Flo Performer Introducer Set white caps may disconnect
Cook Incorporated is recalling Check-Flo Performer Introducer Sets due to white caps that may disconnect from the shaft-hub connection. Affected units were distributed to Australia.
Product
Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number G27242. Performer Introducers are designed to perform as a guiding sheath and/or introducer sheath and come with a Check Flo valve.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0037-2025·2024-10-16
FDA Recalls EPIONE Device Due to Internal Component Corrosion
Quantum Surgical recalls 2 units of the EPIONE device v1.0.2 because rust has developed on the central axis component of the Needle Guide product. These units were distributed in Florida.
Product
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography (CT) guided percutaneous procedures. Du
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0043-2025·2024-10-16
Medical Device Recall: Respiratory Panel May Report Incorrect hMPV Results
The NxTAG Respiratory Pathogen Panel may produce false positive results for human Metapneumovirus (hMPV), potentially leading to incorrect co-infection diagnoses.
Product
NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0034-2025·2024-10-16
MEDLINE Digital Blood Pressure Monitor Recalled Due to Microchip Faults
MEDLINE is recalling 7,428 Automatic Digital Blood Pressure Monitors due to a faulty microchip causing power-on failures, display issues, and overheating. Units were distributed in the US, Panama, and Jamaica.
Product
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0052-2025·2024-10-16
Monarch Platform Urology Device Recalled for Power Cord Electrical Hazard
Auris Health is recalling Monarch Platform (Urology) devices due to strain relief defects in power cords that may cause electrical short and potential shock to operating room staff.
Product
Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0050-2025·2024-10-16
StealthStation S8 Spine Surgery Navigation System Recalled for Software Defects
Medtronic is recalling 1,801 StealthStation S8 surgical navigation systems due to software anomalies that can flip navigation images during spine surgery and prevent warning messages for suboptimal imaging settings.
Product
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine software, is intended as an aid for precisely locating anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0042-2025·2024-10-16
Respiratory Pathogen Panel Recalled Due to False Positive Results
The NxTAG Respiratory Pathogen Panel is recalled due to false positive results for human metapneumovirus in about 7.6% of samples, especially those positive for other respiratory pathogens.
Product
NxTAG Respiratory Pathogen Panel, REF: I051C0447
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0025-2025·2024-10-16
Medical Analyzer Software Flaw Allows Use of Expired Calibrator
Beckman Coulter DxI 9000 immunoassay analyzers with software version 1.16.2 and prior can process orders using expired calibration material, potentially producing incorrect patient laboratory test results.
Product
Beckman Coulter Dxl 9000 Access Immunoassay Analyzer, REF #C11137. An in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Category
Medical Device
Distribution
9 states
ModerateFDA (Devices)·Z-0031-2025·2024-10-16
Aligned Medical Tonsil Packs Recalled Due to Improper-Use Kit Component
Windstone Medical Packaging is recalling Aligned Medical Tonsil Pack kits due to a component under recall for improper use. Approximately 180 packs were distributed nationwide.
Product
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0028-2025·2024-10-16
Aligned Medical Tonsil ENT Pack Recalled for Component Under Separate Recall
Windstone Medical is recalling 894 Aligned Medical Tonsil ENT Packs containing Cardinal Health Salem Sump PVC tubes due to improper use concerns with a component under a separate recall action.
Product
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0044-2025·2024-10-16
MAKO Integrated Cutting System Handpiece Recalled for Characterization Process Error
Howmedica Osteonics Corp. is recalling 897 MAKO Integrated Cutting System (MICS) Handpieces worldwide due to a manufacturing characterization process error that resulted in incorrect constant values being assigned to affected units.
Product
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0024-2025·2024-10-16
iCast Covered Stent Recalled for Unique Device Identifier Labeling Error
Atrium Medical Corporation is recalling 11 iCast Covered Stents (Model 42616) due to an error in the Unique Device Identifier (UDI) printed on the distribution label. No illnesses or injuries have been reported.
Product
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0041-2025·2024-10-16
Inspire Model 4063 Stimulation Lead Labeling Error — Serial Number Mismatch
Inspire Medical Systems is recalling 457 Model 4063 Stimulation Leads because the serial number on the shelf box does not match the serial number of the device inside, creating identification and traceability issues.
Product
Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0040-2025·2024-10-16
Inspire Respiratory Sensing Lead Model 4340 Serial Number Label Mismatch
FDA recall of 152 Inspire Model 4340 Respiratory Sensing Lead units due to a labeling error—the serial number printed on the product box does not match the actual serial number of the device inside.
Product
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Category
Medical Device
Distribution
Distributed nationwide

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4876–4900 of 13543