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

4776–4800 of 13449

HighFDA (Devices)·Z-0096-2025·2024-10-23
Boston Scientific Medical Device Software Error Affects Vessel Imaging Display
The Boston Scientific AVVIGO+ Guidance System displays an incorrect grid overlay when used with the OptiCross 18 catheter in Live or Record mode, potentially affecting depth reference settings. No injuries have been reported.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT 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
HighFDA (Devices)·Z-0087-2025·2024-10-23
Leica Cryostat Model CM1850 Lacks Fire-Risk Warning for Flammable Sprays
Leica Biosystems is recalling Cryostat Model CM1850 (322 units, US nationwide) due to missing warnings about fire hazard from flammable freezing sprays. The device's labeling prior to 2019 did not warn users that flammable sprays used in the chamber can ignite and cause serious injuries.
Product
Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0086-2025·2024-10-23
Leica Biosystems Cryostat lacks warning for flammable freezing spray use
Leica Biosystems Cryostat Model CM1510 S is recalled due to missing warning labels about flammable freezing sprays, which can ignite and cause serious injury. The device labeling lacked fire hazard warnings prior to 2019.
Product
Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0129-2025·2024-10-23
Rolling Walker Backrest May Disengage During Position Adjustment
Nova Ortho-Med is recalling 1,886 MONARCH ROLLATOR BLUE rolling walkers due to a potential fall hazard. The backrest may disengage when users shift from a slouched to upright seated position.
Product
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE Model/Catalog Number: 4329BL Product Description: ROLLING WALKER MOBILITY AID
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0067-2025·2024-10-23
IntelliSystem Inflation Device from Merit Medical Recalled for Sterile Barrier Defect
Merit Medical Systems is recalling 429 IntelliSystem Inflation Devices due to a potential hole in the sterile barrier that could allow pathogen exposure and infection.
Product
IntelliSystem Inflation Device, REF: IN1525/D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0091-2025·2024-10-23
Cue Health COVID-19 Test Cartridge Recalled for Unapproved Distribution
Cue Health Inc. is recalling 248,109 COVID-19 test kits (56 lots) that were modified and distributed without FDA approval or authorization. Users should discontinue use and contact the manufacturer.
Product
Cue Health COVID-19 Test Cartridge REF 2900005 Cue COVID-19 Test Cue COVID-19 Test for Home and Over The Counter (OTC)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0062-2025·2024-10-23
Monarch Balloon Angioplasty Syringes Recalled Due to Sterile Barrier Defects
Merit Medical Systems is recalling 432 Monarch 30 ATM syringes used in balloon angioplasty procedures due to manufacturing defects creating holes in the sterile Tyvek barrier.
Product
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0064-2025·2024-10-23
Blue Diamond Digital Inflation Devices Recalled for Sterile Barrier Defect
Merit Medical Systems is recalling Blue Diamond Digital Inflation Devices due to potential sterile barrier defects. Affected devices may have small holes that could allow exposure to pathogens, creating infection risk.
Product
Blue Diamond Digital Inflation Device, REF: IN7152/C, IN7352/C, IN7403/C, IN7802/C, IN7852/C, IN7130/C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0119-2025·2024-10-23
Medline Heart CABG Cannulae Recalled Due to Incorrect Model Labeling
Medline Industries is recalling 15 kits of MEDLINE HEART CABG DLP Vessel Cannulae due to incorrect model labeling discovered during manufacturing.
Product
MEDLINE HEART CABG CDS, REF CDS983376R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0085-2025·2024-10-23
Leica Cryostat Model CM1100 Recalled for Fire Risk from Flammable Freezing Sprays
Leica Biosystems recalls its Cryostat Model CM1100 due to inadequate warnings about using flammable freezing sprays, which can ignite and cause serious injuries. The device labeling lacked required safety warnings prior to 2019.
Product
Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0126-2025·2024-10-23
Change Healthcare Cardiology Hemodynamic Software Calculation Error Recall
Change Healthcare Cardiology Hemo software versions 14.1.1–15.1 may produce inaccurate hemodynamic calculations due to unit-of-measurement configuration errors, potentially leading to misdiagnosis and inappropriate patient treatment.
Product
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0107-2025·2024-10-23
[pending] Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL US; the system ut
Pending LLM rewrite. Source: FDA_DEVICE Z-0107-2025.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL 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 incl
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0095-2025·2024-10-23
Boston Scientific AVVIGO+ Imaging System Grid Overlay Display Error
A software anomaly in the Boston Scientific AVVIGO+ Multi-Modality Guidance System causes an incorrect grid overlay display when used with certain catheters. The wrong overlay may lead to incorrect measurement references during imaging procedures.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO+ BRIDGE TO INTEGRATED KIT; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0114-2025·2024-10-23
Boston Scientific AVVIGO+ Cardiac Imaging System Grid Display Error
A software anomaly in Boston Scientific's AVVIGO+ system causes an incorrect 9-grid overlay to display instead of the correct 15-grid overlay when connected to OptiCross 18 catheters, potentially affecting clinical interpretation of vascular imaging.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO MOB UPGRADE 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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0094-2025·2024-10-23
Access TSH assay reagent packs may produce erroneously low results
Certain lots of Beckman Coulter Access TSH reagent packs may produce erroneously low thyroid-stimulating hormone results. Affected kits should be verified before clinical use.
Product
The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative etermdination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid s
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0100-2025·2024-10-23
Boston Scientific AVVIGO+ Multi-Modality Imaging System Grid Overlay Display Error
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software error that displays incorrect 9-grid marks instead of 15-grid marks in Live and Record modes. This display error could affect physicians' ability to set proper reference depths during intravascular imaging procedures.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT 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
HighFDA (Devices)·Z-0105-2025·2024-10-23
Boston Scientific AVVIGO+ Multi-Modality Guidance System Grid Display Software Defect
Boston Scientific is recalling the AVVIGO+ Guidance System for a software defect that displays incorrect grid overlays when connected to OptiCross 18 catheters. The error affects Live and Record modes only; no injuries have been reported.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM EVAL - 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 modalitie
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0108-2025·2024-10-23
Boston Scientific AVVIGO+ Imaging System Grid Display Error
Boston Scientific is recalling AVVIGO+ Multi-Modality Guidance Systems due to a software error causing incorrect grid overlay display when used with OptiCross 18 catheters, which could affect measurement accuracy.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + MOB SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0099-2025·2024-10-23
Boston Scientific imaging system software error in grid overlay display
Boston Scientific AVVIGO+ imaging system has a software error causing incorrect grid overlay display in Live and Record modes, potentially affecting depth reference during vascular procedures. 2 units are recalled.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO + INT SYSTEM JAPAN; the system utilizes an interactive display to provide physicians with physiologic, intravascular and/or intracardiac anatomical information. The system can provide various modalities which includ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0127-2025·2024-10-23
Horizon Cardiology Hemodynamic System Recalled for Configuration Error
Horizon Cardiology Hemo Version 12.2 is recalled for a unit-of-measurement configuration issue that can produce incorrect hemodynamic calculations, potentially resulting in misdiagnosis and inappropriate treatment. The recall affects 3 worldwide systems.
Product
Horizon Cardiology Hemo. Version 12.2.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0059-2025·2024-10-23
Monarch Inflation Device Recalled Due to Sterile Barrier Breaches
Merit Medical Systems is recalling 1,120 Monarch Inflation Devices due to manufacturing defects causing holes and breaches in the sterile Tyvek barrier. Affected devices distributed worldwide may pose contamination risk during cardiac interventions.
Product
Monarch Inflation Device 30 atm/bar MAP302 Honor Hemostasis Valve Metal Insertion Tool Torque Device REF IN2330 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measur
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0066-2025·2024-10-23
DiamondTOUCH Digital Inflation Device Sterile Barrier Defect Recall
Merit Medical Systems is recalling the DiamondTOUCH Digital Inflation Device due to a small hole in the sterile barrier. The defect may expose patients to pathogens or pyrogens, potentially causing infection.
Product
DiamondTOUCH Digital Inflation Device, REF: IN9135/A, IN9152/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0056-2025·2024-10-23
Olympus EVIS EXERA III Video System Recalled for Startup Failure
Olympus is recalling 45 units of the EVIS EXERA III Video System Center (Model CV-190) that fail to start due to power supply defects. The endoscopy device was distributed nationwide.
Product
EVIS EXERA III Video System Center Model Number CV-190. Intended to be used with OLYMPUS camera heads, endoscopes, light sources, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopic diagnosis, treatment, and video observation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0121-2025·2024-10-23
Open Heart Surgical Kit Recalled for Incorrect Vessel Cannulae Model Labeling
Medline Industries is recalling 123 kits of its Open Heart Pack after discovering that model 30001 vessel cannulae were incorrectly labeled as model 30000. This labeling error could lead to use of the wrong surgical instrument during open heart procedures.
Product
MEDLINE OPEN HEART PACK, REF DYNJ66216C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0110-2025·2024-10-23
Boston Scientific AVVIGO+ Imaging System Grid Display Overlay Error
Boston Scientific is recalling 5 units of its AVVIGO+ Guidance System due to a software error that displays an incorrect grid overlay when connected to OptiCross 18 Peripheral Imaging Catheters in Live or Record mode.
Product
Boston Scientific AVVIGO+ Multi-Modality Guidance System, AVVIGO II TO AVVIGO + INT Z UPGRADE JP; 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

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4776–4800 of 13449