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. 2,536 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,536 in last 12 months

Showing 2160121620 of 29,188 recalls

Medical DeviceDecember 22, 2015· Applied Medical Resources Corp

Recalled Item: STD KIT GK213 Recalled by Applied Medical Resources Corp Due to Applied...

The Issue: Applied Medical Resources Corporation is recalling CA500 Epix Universal Clip...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Arjo, Inc. dba ArjoHuntleigh

Recalled Item: The Concerto Basic Shower Trolley is intended for assisted hygiene care...

The Issue: Reports of the bolts connecting the stretcher to the hydraulic piston and...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Therakos Inc

Recalled Item: The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog...

The Issue: The Mallinckrodt (Therakos) post-market monitoring process detected an...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Ortho-Clinical Diagnostics

Recalled Item: VITROS 5600 Chemistry System Recalled by Ortho-Clinical Diagnostics Due to...

The Issue: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· ConMed Corporation

Recalled Item: Hip Preservation System Signature Series PreBent Burs under the following...

The Issue: Metal shavings released from burs during use are due to contact between the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Ortho-Clinical Diagnostics

Recalled Item: VITROS 350 Chemistry System Recalled by Ortho-Clinical Diagnostics Due to...

The Issue: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Northeast Laboratory Services, Inc.

Recalled Item: NEL- GBS Medium (Broth 3 ml Fill 13 x 100 mm Screw Cap Tube Catalog No.:...

The Issue: Product marketed without a 510 (k)

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Ortho-Clinical Diagnostics

Recalled Item: VITROS 5 Recalled by Ortho-Clinical Diagnostics Due to Increased U90-382 or...

The Issue: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Northeast Laboratory Services, Inc.

Recalled Item: NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.:...

The Issue: Product marketed without a 510 (k)

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Baxter Corporation Englewood

Recalled Item: Baxter Recalled by Baxter Corporation Englewood Due to All lots of RAPIDFILL...

The Issue: All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Ortho-Clinical Diagnostics

Recalled Item: VITROS 250 Chemistry Systems Recalled by Ortho-Clinical Diagnostics Due to...

The Issue: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Ortho-Clinical Diagnostics

Recalled Item: VITROS 4600 Chemistry System Recalled by Ortho-Clinical Diagnostics Due to...

The Issue: Increased U90-382 or 6LU condition codes generated by VITROS 250, 350, 5,1...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· C.R. Bard, Inc.

Recalled Item: BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary...

The Issue: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· Stryker Spine

Recalled Item: Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine...

The Issue: Reported jamming of the impaction handle when assembled to the Inserter...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· EndoChoice, Inc.

Recalled Item: Fuse 1C Colonoscope Recalled by EndoChoice, Inc. Due to The bending section...

The Issue: The bending section of the device may partially separate from the insertion...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· Arkray Factory USA, Inc.

Recalled Item: arkray SPOTCHEM II Basic Panel - 1 Reagent test strips Recalled by Arkray...

The Issue: One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 18, 2015· Arkray Factory USA, Inc.

Recalled Item: arkray SPOTCHEM II Glucose Reagent test strips Recalled by Arkray Factory...

The Issue: One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 18, 2015· GE Medical Systems, LLC

Recalled Item: Mavig Monitor Suspension System Recalled by GE Medical Systems, LLC Due to...

The Issue: GE Healthcare has recently become aware of a reported incident in which a...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· C.R. Bard, Inc.

Recalled Item: BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter Recalled by C.R. Bard,...

The Issue: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· NeoCoil, LLC

Recalled Item: NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil Recalled by NeoCoil, LLC...

The Issue: Potential for higher than specified surface temperatures. Use of 3.0T GEM...

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

Class II — Potential Health HazardOngoing