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

5326–5350 of 27375

HighFDA (Devices)·Z-2125-2024·2024-05-29
MEDLINE non-sterile syringes recalled for out-of-specification piston configuration
Medline is recalling non-sterile syringes with piston sizes and configurations that exceed the FDA-cleared specification range. The affected devices may not function as originally tested and approved.
Product
Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE CONTRAST Model/Catalog Number: 91860 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1843-2024·2024-05-29
Evolution 1.5T MR Systems: Loose Terminal Connection Fire Risk
Philips Evolution 1.5T MR systems may have loose g-MDU terminal connections that could create electrical hotspots and cause fires. The recall affects 56 units distributed worldwide.
Product
Evolution upgrade 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device Model Number (REF): (1) 782116; (2) 782148
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2104-2024·2024-05-29
Wolf Medical 12 mL Syringes Recalled for Regulatory Non-Compliance
Jiangsu Shenli Medical Production is recalling approximately 724,500 Wolf Medical 12 mL syringes because the product configurations exceed the scope of FDA clearance. Units distributed nationwide should be returned.
Product
Brand Name: Wolf Medical Product Name: 12 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR12L Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1859-2024·2024-05-29
Philips Magnetic Resonance System MR RT Upgrades Recalled for Fire Risk
Philips is recalling MR RT Upgrades Magnetic Resonance diagnostic systems due to a loose terminal connection in the mains distribution unit that could cause smoke or fire. Two units with serial numbers 70980 and 71569 are affected worldwide.
Product
MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1853-2024·2024-05-29
Philips Intera 1.5T MRI System Mains Connection Defect Poses Fire Risk
Philips is recalling 200 Intera 1.5T MRI systems worldwide due to loose mains distribution unit connections that may cause electrical hotspots, creating fire and smoke hazards in hospital technical rooms.
Product
Intera 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781295
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2109-2024·2024-05-29
FDA Recalls GMAX 5ML Syringes for Out-of-Specification Piston Configuration
Jiangsu Shenli Medical is recalling 1.248 million GMAX SYR 5ML/LL syringes because the piston sizes and configurations fall outside the range cleared by FDA. The affected non-sterile syringes were distributed nationwide.
Product
Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2062-2024·2024-05-29
Medline 10mL Syringes Recalled for Manufacturing Outside Approved Specifications
Medline is recalling approximately 525,700 non-sterile 10mL syringes manufactured with sizes and configurations exceeding FDA-approved specifications. No injuries or illnesses have been reported.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L RED Model/Catalog Number: 91830 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2105-2024·2024-05-29
Wolf Medical Syringes Recalled for Exceeding Approved Specifications
Wolf Medical 20 mL syringes are recalled because their piston syringe sizes and configurations exceed FDA-approved specifications under the manufacturer's 510(k) clearance. Approximately 378,900 units were distributed nationwide in six states.
Product
Brand Name: Wolf Medical Product Name: 20 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR20L Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2126-2024·2024-05-29
Medline non-sterile syringes recalled for out-of-specification manufacturing
Jiangsu Shenli Medical is recalling Medline non-sterile syringes (Model 91862, Lot 63722030001) because sizes and configurations exceed FDA-cleared specifications. The recall affects 400 units distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Product
Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862 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-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-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-1874-2024·2024-05-29
FDA Recalls Prelude Guide Sheath Roadster for Component Size Mismatch
Merit Medical Systems is recalling 18 units of Prelude Guide Sheath Roadster due to sheaths labeled as .018 dilators potentially containing .038 dilators instead. The mismatch poses a risk if the wrong-sized component is used during medical procedures.
Product
Prelude Guide Sheath Roadster, REF PG5F45S018, 5F 0.076 (1.9 mm), 45 cm, STERILE EO, RX ONLY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2114-2024·2024-05-29
GMAX SYR 30ML/LL Syringes Recalled for Exceeding 510(k) Clearance
GMAX SYR 30ML/LL syringes manufactured by Jiangsu Shenli Medical have been recalled because their sizes and configurations exceed the FDA 510(k) specifications approved for these devices. The recall affects 1,117,500 units distributed nationwide.
Product
Brand Name: GMAX Product Name: SYR 30ML/LL syringe Model/Catalog Number: TS2230L-M Product Description: NON-Sterile syringes without needles for single use Component: No
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-1869-2024·2024-05-29
2008T BlueStar Hemodialysis Machine Blood Pump Rotor Recalled for Loose Component
Fresenius recalls 334 2008T BlueStar hemodialysis machines with defective blood pump rotors that may have loose or dislodged guide sheaves after extended clinical use.
Product
2008T BlueStar Hemodialysis Machine, Model 191128 with Component: Blood Pump Rotor, Model Number: F40015481 Rev A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2098-2024·2024-05-29
Medline non-sterile syringes recalled for out-of-specification piston configurations
Medline non-sterile syringes (Model 91880) are being recalled because the piston sizes and configurations exceed what the manufacturer submitted for FDA approval. No illnesses or injuries have been reported.
Product
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L BLUE Model/Catalog Number: 91880 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2108-2024·2024-05-29
FDA recalls GMAX non-sterile syringes sold outside approved specifications
FDA is recalling approximately 1.64 million GMAX non-sterile syringes manufactured by Jiangsu Shenli Medical because they were sold in configurations not approved by the agency.
Product
Brand Name: GMAX Product Name: SYR 3ML/LL syringe Model/Catalog Number: TS2203L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2117-2024·2024-05-29
GMAX SYR 10ML/LS Syringes Recalled for Non-Sterile Configuration and Regulatory Non-Compliance
Jiangsu Shenli Medical is recalling non-sterile GMAX syringes for configurations that exceed FDA 510(k) clearance limits. Distributed nationwide, these devices pose infection risk.
Product
Brand Name: GMAX Product Name: SYR 10ML/LS syringe Model/Catalog Number: TS2210S-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1881-2024·2024-05-29
SURGIFOAM Absorbable Gelatin Powder Kit Recalled for Open Applicator Tip Seals
Ethicon recalls SURGIFOAM Absorbable Gelatin Powder Kit (Product Code 1979) due to open seals on applicator tips in three lots. The recall affects 5,184 units distributed nationwide.
Product
SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.
Category
Medical Device
Distribution
Distributed nationwide
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-2094-2024·2024-05-29
Medline Non-Sterile Syringes Model 91876 Recalled for Outside Specification Sizes
Medline non-sterile syringes (Model 91876) are being recalled because certain lot codes contain sizes and configurations that exceed the range cleared by the FDA. No injuries or illnesses have been reported.
Product
Brand Name: MEDLINE Product Name: SYR CNTR 10ML L/L YELLOW Model/Catalog Number: 91876 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-2050-2024·2024-05-29
Non-Sterile Syringes Recalled Due to Manufacturing Specification Violation
Jiangsu Shenli Medical is recalling 754,600 non-sterile syringes because the piston syringe sizes and configurations exceed those cleared by the FDA. Affected units were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/S Model/Catalog Number: 83085 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1849-2024·2024-05-29
MRI Scanner Terminal Connection Fire and Smoke Risk
Philips Ingenia 3.0T CX MRI scanners may experience loose terminal connections in the global Mains Distribution Unit (g-MDU) that could create fire or smoke hazards. The recall affects 350 units distributed worldwide.
Product
Ingenia 3.0T CX Model Number (REF): (1) 782105 (2) 781271
Category
Medical Device
Distribution
Distributed nationwide

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5326–5350 of 27375