Product Recalls in Tennessee

Product recalls affecting Tennessee — including food, drugs, consumer products, medical devices, and vehicles distributed to Tennessee. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,547 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,547 in last 12 months

Showing 2108121100 of 29,188 recalls

Medical DeviceFebruary 23, 2016· Synthes (USA) Products LLC

Recalled Item: Titanium Low Profile Neuro Screw Recalled by Synthes (USA) Products LLC Due...

The Issue: Out of specification at the thread. The thread height of these screws is...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 23, 2016· Mako Surgical Corporation

Recalled Item: RESTORIS PST RIO Offset Shell Impactor For use by orthopedic Recalled by...

The Issue: Potential disassociation of the orientation pin.

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 23, 2016· Roche Diagnostics Operations, Inc.

Recalled Item: cobas p 512 pre-analytical system Pre-analytical sample handling that...

The Issue: Due to a false triggering or detection of the lifting gripper READY signal,...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 23, 2016· Dexcom Inc

Recalled Item: Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495...

The Issue: Customers may not receive an intended audible alarm or alert if relying on...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 23, 2016· Maquet Cardiovascular Us Sales, Llc

Recalled Item: Custom Tubing Packs Custom tubing pack for oxygenators Recalled by Maquet...

The Issue: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 23, 2016· Maquet Cardiovascular Us Sales, Llc

Recalled Item: HLS Set Advanced with BIOLINE Coating Custom tubing packs for the oxygenator...

The Issue: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 23, 2016· Dexcom Inc

Recalled Item: Dexcom G4 PLATINUM (Professional) Receiver Receiver Part Number: MT20649...

The Issue: Customers may not receive an intended audible alarm or alert if relying on...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 23, 2016· Covidien Medical Products (Shanghai) Manufacturing L.L.C.

Recalled Item: Short Percutaneous Antenna with Thermosphere" Technology Standard...

The Issue: Medtronic is voluntarily recalling specific item codes and production lots...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 23, 2016· X-NAV Technologies, LLC

Recalled Item: X-Guide Surgical Navigation System Recalled by X-NAV Technologies, LLC Due...

The Issue: The X-Guide system utilizes an X-Clip (PN P007665) which contains fiducials...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 23, 2016· Dexcom Inc

Recalled Item: Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL)...

The Issue: Customers may not receive an intended audible alarm or alert if relying on...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 23, 2016· Dexcom Inc

Recalled Item: Dexcom G5 Mobile Receiver Receiver Part Number: MT22719 Receiver (mg/dL)...

The Issue: Customers may not receive an intended audible alarm or alert if relying on...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 23, 2016· Maquet Cardiovascular Us Sales, Llc

Recalled Item: QUADROX-i oxygenators Custom tubing packs for the oxygenator Recalled by...

The Issue: Maquet Cardiopulmonary (MCP) is conducting a voluntary recall based on the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 22, 2016· Pentax Medical Company

Recalled Item: Video Duodenoscope Recalled by Pentax Medical Company Due to Pentax Medical...

The Issue: Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 22, 2016· Innovative Ophthalmic Products, Inc

Recalled Item: Molteno3 Glaucoma Implants G-Series: GS-Single Plate 175mm2 (IOP reorder#:...

The Issue: Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 19, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: Artis zee/zeego (system Recalled by Siemens Medical Solutions USA, Inc Due...

The Issue: Possible leak in the cooling system, fluids could potentially seep into the...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 19, 2016· Integrated Science Systems Inc

Recalled Item: Sure Vue Color Staph 150T Recalled by Integrated Science Systems Inc Due to...

The Issue: Customer complaints of very weak reactions with the kit, or false negative...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 19, 2016· Siemens Medical Solutions USA, Inc

Recalled Item: Cios Alpha Recalled by Siemens Medical Solutions USA, Inc Due to Software...

The Issue: Software issues on Cios Alpha mobile C-Arm system

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 19, 2016· Villa Radiology Systems LLC

Recalled Item: Juno DRF Recalled by Villa Radiology Systems LLC Due to The analysis showed...

The Issue: The analysis showed that the incident was caused by a chain of four faults:...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 19, 2016· Villa Radiology Systems LLC

Recalled Item: Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of...

The Issue: The analysis showed that the incident was caused by a chain of four faults:...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 19, 2016· Villa Radiology Systems LLC

Recalled Item: Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine...

The Issue: The analysis showed that the incident was caused by a chain of four faults:...

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardOngoing