State

Tennessee product recalls

20,189 recalls have nationwide distribution and so reach Tennessee. 0 additional recalls listed Tennessee specifically in their distribution scope.

About recalls in Tennessee

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Tennessee consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

9051–9075 of 20189

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-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-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-1864-2024·2024-05-29
Philips Sonalleve MR HIFU 3.0T diagnostic system fire risk recall
Philips is recalling 4 Sonalleve MR HIFU 3.0T diagnostic systems worldwide due to loose electrical connections in the mains distribution unit that may create fire hazards in hospital settings.
Product
Sonalleve MR HIFU 3.0T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781361
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-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-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-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-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-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-1884-2024·2024-05-29
Noblus AC Adapter for Ultrasound System Recalled for Smoke Hazard
FUJIFILM is recalling Noblus AC Adapters nationwide due to fire and smoke hazard. The adapters can overheat and generate smoke when the power cable is repeatedly inserted and removed.
Product
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24
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-2097-2024·2024-05-29
Non-Sterile Syringes Recalled for Exceeding FDA Clearance Scope
Jiangsu Shenli Medical has recalled Medline non-sterile syringes because manufactured sizes and configurations exceed the FDA-cleared scope. No illnesses or injuries have been reported.
Product
Brand Name: MEDLINE Product Name: SYR CNTRL 10ML L/L GREEN Model/Catalog Number: 91879 Product Description: NON-Sterile syringes without needles for single use Component: No
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-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-2048-2024·2024-05-29
Non-sterile Piston Syringes Distributed Outside FDA-Approved Specifications
Medline piston syringes (Model 83083) manufactured by Jiangsu Shenli are being recalled because their sizes and configurations fall outside FDA-approved specifications. Approximately 494,000 units are affected across the United States.
Product
Brand Name: MEDLINE Product Name: SYR 3ML L/S Model/Catalog Number: 83083 Product Description: NON-Sterile syringes without needles for single use Component: No
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-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-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-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-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-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-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-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-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