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

5351–5375 of 27364

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-2112-2024·2024-05-29
GMAX Non-Sterile Syringes Recalled Due to Regulatory Non-Compliance
The FDA is recalling 98,700 GMAX non-sterile syringes (Model TS2212L-M) because their sizes and configurations exceed FDA-cleared specifications. Affected units were distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Product
Brand Name: GMAX Product Name: SYR 12ML/LL syringe Model/Catalog Number: TS2212L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1845-2024·2024-05-29
Philips Ingenia 1.5T MRI machines recalled for loose power connection fire risk
Philips is recalling 2,262 Ingenia 1.5T MRI systems worldwide because a loose terminal connection in the power distribution unit can overheat and cause fire or smoke.
Product
Ingenia 1.5T Model Number (REF): (1) 782140; (2) 782115; (3) 782101; (4) 781396; (5) 781341; (6) 781315
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1862-2024·2024-05-29
Philips MR Systems Recalled for Loose Electrical Connection Fire Hazard
Philips has recalled 200 SmartPath to dStream MR imaging systems worldwide due to a loose electrical connection in the g-MDU unit that may create a fire hazard in hospital technical rooms.
Product
SmartPath to dStream for XR and 3.0T- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782129; (2) 782113; (3) 781270
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-2093-2024·2024-05-29
Medline Non-Sterile Syringes Recalled for Exceeding Approved Specifications
Jiangsu Shenli Medical Production Co., Ltd. is recalling Medline brand 10ML non-sterile syringes (Model 91874) because piston sizes and configurations exceed the range approved under the firm's FDA 510(k) clearance.
Product
Brand Name: MEDLINE Product Name: SYR 10ML L/S RED Model/Catalog Number: 91874 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-1872-2024·2024-05-29
Philips Incisive CT Scanner Metal Mounting Box May Expel Fragments
A metal mounting box on the rotating scanner in the Philips Incisive CT system may become damaged and contact other components, potentially expelling fragments at low velocity. This recall affects 155 units distributed nationwide.
Product
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
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-2107-2024·2024-05-29
60 mL Luer Lock Syringes Recalled for Manufacturing Outside FDA Clearance
Jiangsu Shenli Medical is recalling Wolf Medical 60 mL Luer Lock piston syringes because they were manufactured outside the scope of the firm's FDA 510(k) clearance.
Product
Brand Name: Wolf Medical Product Name: 60 mL (cc) Luer Lock STERILE LATEX FREE NON PYROGENIC Model/Catalog Number: SYR60L Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2090-2024·2024-05-29
Medline 5ML Heparin Syringes Recalled for Specification Non-Compliance
Medline 5ML heparin syringes (Model 91867) are being recalled because the syringe sizes and configurations do not match the range of products approved by the FDA. No injuries or illnesses have been reported.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L BLUE HEPARIN Model/Catalog Number: 91867 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-1863-2024·2024-05-29
Philips MRI System Recall: Loose Electrical Terminal May Cause Fire
Philips MRI diagnostic systems are recalled because a loose electrical connection in the g-MDU unit may create a hotspot, potentially causing fire and smoke in hospital technical areas.
Product
SmartPath to Ingenia Elition X - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 782118
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2058-2024·2024-05-29
MEDLINE 5ML Syringes Recalled for Non-Compliance with FDA Clearance
Jiangsu Shenli Medical is recalling MEDLINE non-sterile 5ML syringes (Model 91826) because certain sizes and configurations exceed the range cleared by the FDA. The company is notifying customers and arranging product retrieval.
Product
Brand Name: MEDLINE Product Name: SYR 5ML L/L GREEN Model/Catalog Number: 91826 Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1816-2024·2024-05-29
Yamaha Optical Inspection Systems Recalled for Missing Laser Safety Certification Label
Yamaha Motor Corporation is recalling 67 Optical Inspection System units (models YSi-V, YSi-V(HS2), YRi-V) distributed nationwide for not bearing the required laser safety certification label.
Product
Optical Inspection System, YSi series, YRi series. Affected models: YSi-V, YSi-V(HS2), YRi-V
Category
Other
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-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-1838-2024·2024-05-29
Philips MRI System Recalled for Potential Fire in Power Distribution Unit
Philips is recalling 2 Achieva 1.5T MRI systems worldwide due to a potential loose connection in the power distribution unit that could cause smoke or fire in hospital technical rooms.
Product
Achieva 1.5T Initial system Model Number (REF): 781178
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-1846-2024·2024-05-29
Philips Ingenia MR Systems Recalled for Fire Risk From Loose Connector
Philips is recalling Ingenia 1.5T CX Magnetic Resonance systems due to a loose power distribution connection that may create a fire hazard in hospital technical rooms.
Product
Ingenia 1.5T CX - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 781262 (2) 781261
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1857-2024·2024-05-29
Philips MR System 1.5T Marlin MRI devices recalled due to fire hazard
Philips is recalling 10 MR System 1.5T Marlin MRI devices worldwide due to a fire and smoke hazard. A loose electrical connection in the mains distribution unit may create a hotspot that causes smoke or fire in hospital technical rooms.
Product
MR system 1.5T Marlin- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781483
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1888-2024·2024-05-29
Olympus InstaClear Lens Sheath Recalled for Potential Distal End Breakage
Olympus has recalled InstaClear Lens Sheaths used in rigid endoscopy because the distal end may break off during procedures. All lot numbers of multiple model variants distributed in the U.S. and internationally are affected.
Product
InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile sheath cleans and clears the lens of a rigid endoscope almost instantly during surgery without have to remove it from the nasal cavity.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1886-2024·2024-05-29
Thyroid Autoantibody Test System Recalled for Falsely Elevated Results
Siemens IMMULITE 2000 Anti-TG Ab thyroid test kits are recalled due to the potential for falsely elevated patient sample results. Affected lots may produce inaccurate results that could lead to misdiagnosis.
Product
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1854-2024·2024-05-29
Philips MR 5300 magnetic resonance systems' mains distribution unit may ignite
Philips has recalled 81 MR 5300 MRI systems worldwide due to a loose electrical connection that may overheat and cause fire or smoke in hospital technical rooms.
Product
MR 5300- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): (1) 782152 (2) 782110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2113-2024·2024-05-29
GMAX Non-Sterile Syringes Recalled for Unapproved Sizes and Configurations
GMAX non-sterile syringes in various sizes and configurations have been recalled because they fall outside the FDA 510(k) scope of the manufacturer's clearance. Affected lots were distributed across six U.S. states.
Product
Brand Name: GMAX Product Name: SYR 20ML/LL syringe Model/Catalog Number: TS2220L-M Product Description: NON-Sterile syringes without needles for single use Component: No
Category
Medical Device
Distribution
Distributed nationwide

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5351–5375 of 27364