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

7026–7050 of 39844

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-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-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-1848-2024·2024-05-29
Philips Recalls Ingenia 3.0T MR Systems for Loose Mains Terminal Fire Hazard
Philips is recalling 1,517 Ingenia 3.0T magnetic resonance (MR) systems due to a potentially loose terminal connection in the mains distribution unit that may create a hotspot and cause fire or smoke.
Product
Ingenia 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782103 (2) 781377 (3) 781342
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1839-2024·2024-05-29
Philips Achieva 3.0T MRI System Recall: Fire Hazard Risk
Philips recalls 386 Achieva 3.0T MRI systems due to a loose terminal connection that may create a hotspot and cause smoke or fire in the equipment room.
Product
Achieva 3.0T Model Number (REF): (1) 781345; (2) 781344; (3) 781278; (4) 781277; (5) 781177
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2054-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Configuration Outside FDA Clearance
Jiangsu Shenli is recalling Medline non-sterile 3mL syringes (Model 91820) nationwide because their configurations exceed FDA clearance scope. Users should discontinue use immediately.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/L RED Model/Catalog Number: 91820 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-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-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-1860-2024·2024-05-29
MRI System Mains Distribution Unit Connection Fire Risk
Loose terminal connections in the mains distribution unit of Philips MRI systems may create electrical hotspots that could cause smoke or fire. The company is recalling 617 affected units worldwide.
Product
SmartPath to dStream for 1.5T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782146; 782112; 781260
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2124-2024·2024-05-29
GMAX SYR 5ML syringes recalled for unapproved piston configurations
FDA recalls 60,000 GMAX SYR 5ML/LL non-sterile syringes manufactured by Jiangsu Shenli Medical Production because the piston syringe sizes and configurations were not cleared under the firm's FDA 510(k) application.
Product
Brand Name: GMAX Product Name: SYR 5ML/LL syringe Model/Catalog Number: TS2205S-M 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-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
HighFDA (Devices)·Z-2072-2024·2024-05-29
Non-Sterile Syringes Recalled for Manufacturing Beyond FDA-Cleared Scope
Jiangsu Shenli Medical recalled 3mL non-sterile syringes because they were manufactured outside the scope of FDA approval. The product was distributed nationwide across six U.S. states.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/L PURPLE Model/Catalog Number: 91840 Product Description: NON-Sterile syringes without needles for single use Component: No
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-2055-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Out-of-Specification Configurations
Medline 3-mL non-sterile syringes are being recalled because their actual sizes and configurations fall outside the FDA-approved range for the manufacturer's 510(k) clearance. 20,000 units were distributed nationwide across six U.S. states.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/L GREEN Model/Catalog Number: 91821 Product Description: NON-Sterile syringes without needles for single use Component: No
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-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-2091-2024·2024-05-29
Medline 10mL Syringes Recalled Due to Non-Conforming Device Configuration
Jiangsu Shenli Medical Production Co. recalls approximately 30,800 non-sterile Medline 10mL syringes because their sizes and configurations fall outside FDA-cleared scope. No injuries reported.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/S BLUE Model/Catalog Number: 91872 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-2100-2024·2024-05-29
Disposable Luer Lock Syringes Recalled for Exceeding Cleared Specifications
Jiangsu Shenli Medical recalled approximately 110,000 MEDIGRATIVE disposable syringes because the manufactured units exceed specifications approved by the FDA.
Product
Brand Name: MEDIGRATIVE Product Name: 100cc/ml disposable luer lock syringe Model/Catalog Number: 10025 Product Description: 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-1887-2024·2024-05-29
Siemens IMMULITE 2000 Anti-TG Ab Test Kits Recalled for Falsely Elevated Results
Siemens Healthcare Diagnostics is recalling certain IMMULITE 2000 Anti-TG Ab test kits due to the potential for falsely elevated thyroid antibody results in patient samples.
Product
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoantibody.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2099-2024·2024-05-29
Medical syringes recalled due to manufacturing specification deviation
Medline is recalling 10mL non-sterile syringes manufactured by Jiangsu Shenli Medical because they were produced outside the range of sizes and configurations approved by the FDA. The affected syringes were distributed nationwide.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/L CONTROL Model/Catalog Number: 91881 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

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7026–7050 of 39844