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

6351–6375 of 13652

HighFDA (Devices)·Z-2043-2024·2024-05-29
Non-sterile Medline syringes recalled for exceeding FDA clearance specifications
Medline 30mL non-sterile syringes (Model 83078) are recalled because their designs fall outside the FDA-cleared specifications. About 4.1 million units distributed in the U.S. are affected.
Product
Brand Name: MEDLINE Product Name: SYR 30ML L/L Model/Catalog Number: 83078 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2101-2024·2024-05-29
FDA Recalls Wolf Medical Disposable Syringes for Non-Conforming Configurations
Jiangsu Shenli Medical has recalled over 1 million Wolf Medical WOLF-PAK 1 mL disposable syringes because piston syringe sizes and configurations exceed those cleared under the company's 510(k) approval.
Product
Brand Name: Wolf Medical - WOLF-PAK Product Name: DISPOSABLE SYRINGE 1 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR01L Serial Number: 850007185411 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1866-2024·2024-05-29
Blood Pump Rotor Model F40015481 Rev A Recalled for Loose Guide Sheaves
Fresenius Medical Care is recalling 45,880 Blood Pump Rotors (Model F40015481 Rev A) due to reports of loose or dislodged guide sheaves after use in clinical facilities.
Product
Blood Pump Rotor, Model Number: F40015481 Rev A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1865-2024·2024-05-29
Philips dStream MR System Terminal Connection May Become Loose and Cause Fire
Philips is recalling its Upgrade dStream MR system due to a potential fire hazard. A loose terminal connection in the g-MDU may create a hotspot causing smoke or fire.
Product
Upgrade dStream - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 782127
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1847-2024·2024-05-29
Philips Ingenia MRI Scanner Mains Distribution Unit Fire Risk Recall
Philips is recalling 139 Ingenia 1.5T S MRI scanners due to a loose terminal connection in the power distribution unit that could create an electrical hotspot and cause smoke or fire. No injuries have been reported.
Product
Ingenia 1.5T S Model Number (REF): 781347
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1842-2024·2024-05-29
MR Imaging System Recall for Loose Electrical Terminal Connection Fire Risk
Philips AchievaXR MR systems may have loose terminal connections in the power distribution unit that could create hotspots and cause smoke or fire. The FDA has recalled 35 affected units worldwide.
Product
AchievaXR -Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): 781253
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1868-2024·2024-05-29
Fresenius 2008T BlueStar Hemodialysis Machine Recalled for Loose Blood Pump Rotor
Fresenius is recalling 12,292 BlueStar hemodialysis machines because the blood pump rotor component can develop loose or dislodged guide sheaves after clinical use. Patients should contact their healthcare provider to verify if their equipment is affected.
Product
2008T BlueStar Hemodialysis Machine, Model 191126 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1841-2024·2024-05-29
Philips Achieva 3.0T PET imaging device poses potential fire hazard
A loose terminal connection in the power distribution unit of Philips Achieva 3.0T TX PET imaging systems may create an electrical hotspot, potentially causing smoke or fire. The device is distributed worldwide.
Product
Achieva 3.0T TX for PET Model Number (REF): 781479
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2086-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Non-Compliant Manufacturing Specifications
Medline non-sterile syringes (Model 91858) are recalled for manufacturing outside FDA-cleared specifications. The recall covers 50,400 units distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L WHITE SALINE Model/Catalog Number: 91858 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2052-2024·2024-05-29
Non-sterile Medline piston syringes recalled for exceeding FDA scope
Medline has recalled SYR 20ML L/L non-sterile piston syringes (Model 83088) manufactured in sizes and configurations outside FDA-cleared specifications. Approximately 13.6 million units were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 20ML L/L Model/Catalog Number: 83088 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2042-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Offering Configurations Outside FDA Approved Clearance Scope
Medline non-sterile syringes are being recalled because configurations and sizes sold exceeded the FDA's approved 510(k) scope. Approximately 502,250 units were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 30ML/LS Model/Catalog Number: 83077 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1836-2024·2024-05-29
Philips Achieva 1.5T MR Systems Electrical Connection Fire Hazard
Philips is recalling 1,585 Achieva 1.5T MR systems worldwide due to a loose g-MDU L3 terminal connection that may create an electrical hotspot causing fire or smoke. No injuries have been reported.
Product
Achieva 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781296 (2) 781343
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1885-2024·2024-05-29
Scopis ENT Navigation Software Contains Visual Guidance Alignment Error
Unreleased software in Scopis ENT surgical navigation systems causes visual guidance to display inaccurately relative to physical reference points, affecting surgical precision. Affects 705 units nationwide.
Product
8000-021-002, Scopis¿ ENT Software with TGS¿ with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2123-2024·2024-05-29
GMAX SYR 60ML/LL Blue Syringes Recalled for Unapproved Specifications
Jiangsu Shenli Medical Production Co. is recalling GMAX SYR 60ML/LL blue syringes because the manufactured sizes and configurations fall outside the range cleared by the FDA. Approximately 116,160 units were distributed nationwide.
Product
Brand Name: GMAX Product Name: SYR 60ML/LL Blue syringe Model/Catalog Number: TS2260LB-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2092-2024·2024-05-29
MEDLINE syringes recalled for sizes outside FDA clearance
MEDLINE is recalling 700 non-sterile 10ML syringes because their piston sizes and configurations exceed the range approved by FDA. No illnesses have been reported. Consumers should stop using these syringes.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/S WHITE LIDO Model/Catalog Number: 91873 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1861-2024·2024-05-29
Philips Medical Device Recalled for Fire Hazard in Electrical Connection
Philips is recalling the SmartPath to dStream for 3.0T medical device due to a loose electrical connection in the mains distribution unit that may cause smoke or fire in hospital technical rooms. Three units are affected.
Product
SmartPath to dStream for 3.0T Model Number (REF): 782145
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2059-2024·2024-05-29
MEDLINE Non-Sterile Syringes Recalled: Sizes Outside FDA Clearance Range
MEDLINE non-sterile syringes (Model 91827) are recalled because piston sizes and configurations are outside the FDA clearance range. The manufacturer is recalling 44,800 units distributed in six U.S. states.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE Model/Catalog Number: 91827 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2077-2024·2024-05-29
MEDLINE Non-Sterile Syringes Recalled Due to Regulatory Non-Compliance
MEDLINE has recalled 42,000 non-sterile syringes (Model 91847) because their sizes and configurations exceed FDA-approved specifications. The products were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L BLUE LIDO Model/Catalog Number: 91847 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1851-2024·2024-05-29
Philips Ingenia Ambition X MR systems recalled for loose terminal connection fire hazard
Philips is recalling 509 Ingenia Ambition X MR systems due to loose terminal connections in the g-MDU L3 unit that may create hotspots and cause smoke or fire in hospital technical rooms.
Product
Ingenia Ambition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782138; (2) 782109; (3) 781356
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1875-2024·2024-05-29
Merit Medical Guide Sheath Roadster Recalled for Incorrect Dilator Sizing
Merit Medical is recalling Prelude Guide Sheath Roadster devices because some sheaths labeled as .018 dilators may actually contain .038 dilators, creating a risk of using incorrectly-sized medical devices.
Product
Prelude Guide Sheath Roadster, REF PG6F45S018, 6F 0.087" (2.2 mm), 45 cm, STERILE EO, RX ONLY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1844-2024·2024-05-29
Medical Device Mains Distribution Unit Recall Due to Fire Risk
The Evolution upgrade 3.0T mains distribution unit is being recalled because its L3 terminal connection may become loose, creating a hotspot that could cause fire or smoke in hospital technical rooms.
Product
Evolution upgrade 3.0T Model Number (REF): (1)782117; (2) 782143
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2084-2024·2024-05-29
MEDLINE Non-Sterile Syringes Recalled for Being Outside Cleared Specifications
Jiangsu Shenli Medical is recalling 33,600 MEDLINE 10ml non-sterile syringes (Model 91856) because they fall outside the FDA-approved specifications, potentially affecting their function.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L RED CONT Model/Catalog Number: 91856 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1873-2024·2024-05-29
Integra Cranial Access Kit Packaging Defects May Compromise Sterility
Integra LifeSciences is recalling 1,822 units of its Cranial Access Kit due to potential holes and tears in the sterile packaging that may compromise device sterility. The kits are used in ventriculostomy procedures.
Product
Integra¿ Cranial access kit (without Prep solutions) Bit and Guard- Used during a ventriculostomy procedure. Catalog Number: INS5HND
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1852-2024·2024-05-29
MRI System Recalled Due to Loose Terminal Connection Fire Hazard
Philips Ingenia Elition X- MRI systems have a loose terminal connection in the power distribution unit that may create a hotspot and cause smoke or fire in hospital settings. No injuries have been reported.
Product
Ingenia Elition X- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781358
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1837-2024·2024-05-29
Philips Achieva 1.5T MR Systems: Loose Terminal Connection Fire Risk
Philips is recalling Achieva 1.5T MR diagnostic systems worldwide due to a potential loose connection in the mains distribution unit that could create a hotspot and cause smoke or fire in hospital technical rooms.
Product
Achieva 1.5T Conversion- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 781283; (2) 781346
Category
Medical Device
Distribution
Distributed nationwide

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6351–6375 of 13652