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 32613280 of 29,188 recalls

Medical DeviceAugust 5, 2024· Abiomed, Inc.

Recalled Item: Impella 5.5 with SmartAssist S2 Set Recalled by Abiomed, Inc. Due to A...

The Issue: A potential device interaction between the Shockwave Coronary IVL Catheter...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 5, 2024· Abiomed, Inc.

Recalled Item: Impella 5.5 with SmartAssist Set Recalled by Abiomed, Inc. Due to A...

The Issue: A potential device interaction between the Shockwave Coronary IVL Catheter...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 5, 2024· Abiomed, Inc.

Recalled Item: Impella CP Smart Assist Set Recalled by Abiomed, Inc. Due to A potential...

The Issue: A potential device interaction between the Shockwave Coronary IVL Catheter...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 5, 2024· Abiomed, Inc.

Recalled Item: Impella CP Pump Set Recalled by Abiomed, Inc. Due to A potential device...

The Issue: A potential device interaction between the Shockwave Coronary IVL Catheter...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 5, 2024· Abiomed, Inc.

Recalled Item: Pump 371 14F LT CMR Set Recalled by Abiomed, Inc. Due to A potential device...

The Issue: A potential device interaction between the Shockwave Coronary IVL Catheter...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 5, 2024· Abiomed, Inc.

Recalled Item: Impella 5.5 Set AU Recalled by Abiomed, Inc. Due to A potential device...

The Issue: A potential device interaction between the Shockwave Coronary IVL Catheter...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 5, 2024· Abiomed, Inc.

Recalled Item: Impella 5.5 with SmartAssist Set Recalled by Abiomed, Inc. Due to A...

The Issue: A potential device interaction between the Shockwave Coronary IVL Catheter...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 2, 2024· AURIS HEALTH INC

Recalled Item: Monarch Platform (Endoscopy) Recalled by AURIS HEALTH INC Due to...

The Issue: Endoscopy/bronchoscopy/urology devices may have a strain relief defect with...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 2, 2024· AURIS HEALTH INC

Recalled Item: Monarch Platform (Urology) Recalled by AURIS HEALTH INC Due to...

The Issue: Endoscopy/bronchoscopy/urology devices may have a strain relief defect with...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 2, 2024· Bard Peripheral Vascular Inc

Recalled Item: BARD MAGNUM Disposable Core Tissue Biopsy Needle MN Recalled by Bard...

The Issue: Due to possible packaging damage (indentations/cuts) cause by manufacturing...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 2, 2024· Ultradent Products, Inc.

Recalled Item: Brand Name: Transcend Product Name: Transcend Singles Universal Body (UB)...

The Issue: Due to a manufacturing issue, red particulates present in the expressed...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 2, 2024· Ultradent Products, Inc.

Recalled Item: Brand Name: Transcend Product Name: Transcend Econo Kit (UB) - Recalled by...

The Issue: Due to a manufacturing issue, red particulates present in the expressed...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 2, 2024· Ultradent Products, Inc.

Recalled Item: Brand Name: Vit-l-escence Product Name: Vit-l-escence Singles A3...

The Issue: Due to a manufacturing issue, red particulates present in the expressed...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 1, 2024· Outset Medical, Inc.

Recalled Item: Tablo Console Recalled by Outset Medical, Inc. Due to Blood leak sensor, a...

The Issue: Blood leak sensor, a component of hemodialysis device, may show decreased...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX FC ESO STENT RMV LL 18X103- Wallflex Esophageal Partially Recalled...

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 1, 2024· Boston Scientific Corporation

Recalled Item: AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Recalled by Boston Scientific...

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially...

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- Wallflex Esophageal Partially Covered...

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered...

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 1, 2024· Boston Scientific Corporation

Recalled Item: WALLFLEX FC ESO STENT RMV LL 23X155- Wallflex Esophageal Partially Recalled...

The Issue: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire...

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

Class II — Potential Health HazardOngoing