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

10376–10400 of 89670

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 (Drugs)·D-0010-2025·2024-10-23
Cisplatin Injection Vials Recalled for Failed Impurity and Degradation Standards
Accord Healthcare is recalling 11,214 vials of Cisplatin Injection due to failed impurity and degradation specifications. The recalled lot was distributed nationwide in the United States and Puerto Rico.
Product
CISPLATIN — CISPLATIN (CISPLATIN)
Category
Drug
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-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-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-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-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-0036-2025·2024-10-23
Wilson-Cook Medical Recalls Hemo-7 and Hemo-10 Hemospray Endoscopic Hemostats
Wilson-Cook Medical is recalling specific lots of Hemo-7 and Hemo-10 Hemospray Endoscopic Hemostats because they were manufactured with nonconforming raw materials.
Product
Cook Medical Hemo-7 Hemospray Endoscopic Hemostat, REF G56572, 2.8 mm, Sterile; and Hemo-10 Hemospray Endoscopic Hemostat, REF G21049, 3.7 mm, Sterile. The device is used for hemostasis of nonvariceal gastrointestinal bleeding.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0132-2025·2024-10-23
Medtronic Vanta Neurostimulator Recall for Premature Battery Depletion
Medtronic is recalling Vanta Implantable Neurostimulators (Model 977006) because battery life depleted faster than expected, leading to earlier surgical replacements or reprogramming.
Product
Vanta Implantable Neurostimulator (INS), Model 977006
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0131-2025·2024-10-23
Rolling Walker Backrest May Disengage During Position Changes Creating Fall Risk
Nova Ortho-Med is recalling 1,585 MONARCH ROLLATOR RED units because the backrest may disengage from its holder when users adjust from a slouched to upright position, creating a fall hazard.
Product
Brand Name: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED Model/Catalog Number: 4329RD Product Description: ROLLING WALKER MOBILITY AID
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·24V789000·2024-10-23
Kenworth and Peterbilt fuel pump barrels may fracture and leak
PACCAR is recalling certain 2025 Kenworth and Peterbilt trucks with Cummins X15 diesel engines because the fuel pump barrels may fracture and cause a fuel leak.
Product
KENWORTH — KENWORTH, PETERBILT W900, 579, T680, C500
Category
Vehicle
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-0072-2025·2024-10-23
basixTOUCH Inflation Device May Have Sterile Barrier Defect
Merit Medical Systems is recalling basixTOUCH Inflation Devices due to a potential hole in the sterile barrier. The defect may expose patients to pathogens and pyrogens, increasing infection risk.
Product
basixTOUCH Inflation Device, REF: IN8130/JPC, IN8152/C, IN8302/C, IN8352/C, IN8802/C, IN8130/C, IN8130/C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0039-2025·2024-10-23
Lemonland Food Corp Recalls Perilla Leaves in Soybean Paste for Undeclared Wheat and Sesame
Lemonland Food Corp recalls Item FLD1000A Perilla Leaves in Soybean Paste distributed in Washington. The product label omits wheat and sesame seeds, which are present in the product.
Product
Item FLD1000A, Perilla Leaves in Soybean Paste, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares Perilla Leaves, Soybean Paste.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0128-2025·2024-10-23
Change Healthcare Cardiology Hemo Software Recalled for Calculation Errors
Change Healthcare is recalling Cardiology Hemo software versions 13.0 through 14.0 because incorrect unit configurations can lead to inaccurate hemodynamic calculations and potential misdiagnosis.
Product
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
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 (Food)·F-0031-2025·2024-10-23
King Harvest Spinach Hummus Recalled for Potential Plastic Fragments
Pacific Coast Fresh CO is recalling 994 tubs of King Harvest Spinach Hummus due to potential plastic fragments. The hummus was distributed in Oregon and Washington with a use-by date of 10/08/24.
Product
King Harvest Spinach Hummus, perishable and refrigerated, packed in plastic tubs with tamper evident lids. Net wt. 10oz. Dist. Exclusively by Pacific Coast Fresh Co Portland, Oregon. UPC 0 25726 31108 7.
Category
Food
Distribution
2 states
HighFDA (Food)·F-0049-2025·2024-10-23
Lemonland Wild Leeks Recalled for Undeclared Wheat and Fish Allergens
Lemonland Food Corp is recalling Item FLD1040A Wild Leeks distributed in Washington due to undeclared wheat and fish (anchovy) allergens. The product label declares soy sauce but omits mandatory allergen warnings.
Product
Item FLD1040A, Wild Leeks, distributed in plastic clamshell containers. Net wt. 0.315lb. The H-Mart label declares: Wild Leeks, Sugar, Soy Sauce.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-0125-2025·2024-10-23
Cortera spinal fixation system screws recalled due to manufacturing specification concerns
XTANT Medical is recalling 330 Cortera spinal fixation system screws marked 'DNI' because they may not have been manufactured to specification and could lack adequate strength if implanted.
Product
Cortera Spinal Fixation System Screw, Poly, Solid, 6.5mm x 45mm, REF: 150100-65045
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0088-2025·2024-10-23
Leica Cryostat Model CM1900 Lacks Warning on Flammable Sprays
Leica Biosystems is recalling the Cryostat Model CM1900 because its labeling lacks a warning about using flammable freezing sprays in the chamber. The sprays can ignite, creating a serious fire and burn hazard.
Product
Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0056-2025·2024-10-23
Hungarian Mushroom Soup Recalled for Possible Presence of Larvae
PCC Community Market's Hungarian Mushroom Soup is being recalled for possible presence of larvae. The affected product was distributed in Washington only.
Product
Hungarian Mushroom Soup sold at PCC Community Market as: (1) Sold in grab and go plastic retail container, net wt. 24 oz. UPC 20452200000. (2) Sold hot in self-serve soup bar. (3) Sometimes used as a sauce for Hungarian Meatballs served in some stores self-serve hot bar.
Category
Food
Distribution
1 state
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
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-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 (Food)·F-0050-2025·2024-10-23
Stir Fried Dried Shrimp Recalled for Undeclared Wheat Allergen
Lemonland Food Corp recalled stir-fried dried shrimp (Item FLD1971) distributed in Washington because wheat is not declared on the label, despite being present in the product.
Product
Item FLD1971, Stir Fried Dried Shrimp, distributed in plastic clamshell containers. Net wt. 0.165lb. The H-Mart label declares: Shrimp, Sesame Oil, Soy Sauce, Corn Syrup, Salt
Category
Food
Distribution
1 state

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10376–10400 of 89670