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

5626–5650 of 39844

ModerateFDA (Devices)·Z-0112-2025·2024-10-23
Medical imaging system software defect causes incorrect grid overlay display
Boston Scientific recalled the AVVIGO+ imaging guidance system due to a software defect that displays a 9-grid overlay instead of the correct 15-grid overlay when connected to OptiCross 18 catheters in Live or Record mode.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO INT UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0124-2025·2024-10-23
Medline Open Heart Kits Recalled Due to Incorrect Cannula Labeling
Medline Industries is recalling 22 Open Heart NIMC Kits because they contain Medtronic DLP Vessel Cannulae that were incorrectly labeled during manufacturing.
Product
MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0093-2025·2024-10-23
Beckman Coulter Urine Chemistry Controls May Produce False Positive Results
Beckman Coulter IRISPEC urine chemistry control materials may intermittently fail to detect negative glucose, producing false positive control results that could delay patient test reporting.
Product
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0120-2025·2024-10-23
Medline Heart Overhead Table Pack recalled for incorrect model labeling
Medline Industries recalls Heart Overhead Table Packs due to incorrect labeling. Some kits were marked as model 30000 when they should be model 30001.
Product
MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0102-2025·2024-10-23
Boston Scientific AVVIGO+ guidance system recalled for grid overlay display error
Boston Scientific's AVVIGO+ guidance system is recalled because a software glitch causes an incorrect grid overlay display when used with an OptiCross 18 catheter. The correct overlay appears in Review mode, and no patient injuries have been reported.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0109-2025·2024-10-23
Boston Scientific AVVIGO+ Medical Device Grid Overlay Display Error
Boston Scientific recalls 161 AVVIGO+ Multi-Modality Guidance Systems due to a software error causing an incorrect grid overlay display in Live and Record modes. The error affects measurement reference accuracy during intravascular imaging procedures.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includes
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0115-2025·2024-10-23
Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly
Boston Scientific is recalling 4 units of the AVVIGO+ Multi-Modality Guidance System because a software error displays the wrong grid overlay during Live or Record mode.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0103-2025·2024-10-23
Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly
Boston Scientific is recalling 14 units of the AVVIGO+ Multi-Modality Guidance System due to a software anomaly that displays an incorrect grid overlay during Live or Record mode.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM - ZERO COST US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities whi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0116-2025·2024-10-23
Boston Scientific Recalls AVVIGO+ Guidance Systems Due to Software Display Error
Boston Scientific is recalling 40 AVVIGO+ Multi-Modality Guidance Systems because a software anomaly causes an incorrect grid overlay to display during Live or Record mode when used with specific catheters.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE US; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities whi
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0098-2025·2024-10-23
Boston Scientific Recalls AVVIGO+ Guidance System Due to Software Anomaly
Boston Scientific is recalling 15 units of the AVVIGO+ Multi-Modality Guidance System because a software anomaly causes an incorrect grid overlay to display during Live or Record mode.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM EU + ROW; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which inc
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0005-2025·2024-10-16
Z-800 Infusion System Recalled for Air-in-Line Software Algorithm Defect
Zyno Medical LLC is recalling the Z-800 Infusion System due to a defect in the air-in-line software algorithm. Approximately 34,994 units distributed nationwide are affected by this Class I FDA recall.
Product
Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z
Category
Medical Device
Distribution
Distributed nationwide
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-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-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-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-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-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-0035-2025·2024-10-16
Philips Patient Information Center iX Network Connectivity Issue Affects Settings Synchronization
Philips Patient Information Center iX devices may fail to synchronize settings when network DHCP leases expire during offline operation, causing the devices to receive new IP addresses that are not recognized after reconnection.
Product
Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0027-2025·2024-10-16
Tonsil tray kits recalled for containing component under improper use recall
Windstone Medical Packaging recalls 642 kits of Aligned Medical Tonsil Trays because they contain Cardinal Health Salem Sump PVC tubes that are subject to a separate recall for improper use.
Product
Aligned Medical Tonsil Tray REF AMS9300A 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
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-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-0053-2025·2024-10-16
Medline Sterile Laparoscopy Pack Recalled for Component Defect
Medline recalls Sterile Laparoscopy Packs due to a manufacturing defect in the Detachable Endo Pocket component. The tube may stretch from the pouch during surgical procedures, potentially affecting tissue collection.
Product
Medline Sterile Laparoscopy Pack, DYNJ68187A (REF), containing the component ConMed/Unimax Detachable Endo Pocket
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0032-2025·2024-10-16
Medline Automatic Digital Blood Pressure Monitors Recalled for Power, Display, and Overheating Issues
Medline is recalling 52,521 automatic digital blood pressure monitors due to a faulty microchip that may cause power failures, display screen issues, or overheating. Consumers should stop using affected units immediately.
Product
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Category
Medical Device
Distribution
Distributed nationwide

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5626–5650 of 39844