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. 2,710 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,710 in last 12 months

Showing 24412460 of 29,188 recalls

Medical DeviceDecember 13, 2024· Trinity Sterile, Inc.

Recalled Item: Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Recalled...

The Issue: Potential for hole in package compromising sterility of the medical kit.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 13, 2024· Trinity Sterile, Inc.

Recalled Item: Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent...

The Issue: Potential for hole in package compromising sterility of the medical kit.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 13, 2024· Trinity Sterile, Inc.

Recalled Item: Brand Name: Tacy Medical Recalled by Trinity Sterile, Inc. Due to Potential...

The Issue: Potential for hole in package compromising sterility of the medical kit.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 12, 2024· LivaNova USA, Inc.

Recalled Item: SenTiva Recalled by LivaNova USA, Inc. Due to Vagus nerve stimulator...

The Issue: Vagus nerve stimulator generators may stop delivering stimulation due to an...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 12, 2024· LivaNova USA, Inc.

Recalled Item: SenTiva Recalled by LivaNova USA, Inc. Due to Vagus nerve stimulator...

The Issue: Vagus nerve stimulator generators may stop delivering stimulation due to an...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 12, 2024· Medtronic Perfusion Systems

Recalled Item: DLP Pediatric One-Piece Arterial Cannulae Recalled by Medtronic Perfusion...

The Issue: Incorrect labeling for seven manufactured lots of certain models of Arterial...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 12, 2024· Medtronic Perfusion Systems

Recalled Item: EOPA Arterial Cannula Recalled by Medtronic Perfusion Systems Due to...

The Issue: Incorrect labeling for seven manufactured lots of certain models of Arterial...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 12, 2024· Medtronic Perfusion Systems

Recalled Item: Select Series Angled Tip Arterial Cannula Recalled by Medtronic Perfusion...

The Issue: Incorrect labeling for seven manufactured lots of certain models of Arterial...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 12, 2024· Boston Scientific Corporation

Recalled Item: PROPONENT DR Pacemaker Recalled by Boston Scientific Corporation Due to A...

The Issue: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 12, 2024· Abiomed, Inc.

Recalled Item: Impella RP Flex with SmartAssist Recalled by Abiomed, Inc. Due to Optical...

The Issue: Optical Sensors have been damaged due to physical interaction between the...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 12, 2024· Boston Scientific Corporation

Recalled Item: ESSENTIO DR Pacemaker Recalled by Boston Scientific Corporation Due to A...

The Issue: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 12, 2024· Boston Scientific Corporation

Recalled Item: VALITUDE CRT-P Recalled by Boston Scientific Corporation Due to A subset of...

The Issue: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 12, 2024· Boston Scientific Corporation

Recalled Item: ACCOLADE DR Pacemaker Recalled by Boston Scientific Corporation Due to A...

The Issue: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 12, 2024· Boston Scientific Corporation

Recalled Item: VISIONIST CRT-P Recalled by Boston Scientific Corporation Due to A subset of...

The Issue: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 12, 2024· Abiomed, Inc.

Recalled Item: Impella RP with SmartAssist Recalled by Abiomed, Inc. Due to Optical Sensors...

The Issue: Optical Sensors have been damaged due to physical interaction between the...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 12, 2024· Boston Scientific Corporation

Recalled Item: ALTRUA 2 DR Pacemaker Recalled by Boston Scientific Corporation Due to A...

The Issue: A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 11, 2024· HF Acquisition Co LLC

Recalled Item: Biological Recalled by HF Acquisition Co LLC Due to Spore test strip...

The Issue: Spore test strip monitoring system, designed for routine monitoring of...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 11, 2024· Nuwellis Inc

Recalled Item: nuwellis AquaFlexFlow UF 500 Plus Recalled by Nuwellis Inc Due to The...

The Issue: The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 10, 2024· ev3 Inc

Recalled Item: Medtronic NanoCross Elite PTA catheter Recalled by ev3 Inc Due to There is...

The Issue: There is the potential for in-vivo balloon deflation issues, including...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 10, 2024· Mercury Enterprises, Inc. dba Mercury Medical

Recalled Item: Neo-Tee T-Piece Resuscitator Recalled by Mercury Enterprises, Inc. dba...

The Issue: Gas powered emergency resuscitator has a circuit flow controller...

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

Class I — Serious Health HazardOngoing