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. 1,036 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
1,036 in last 12 months

Showing 18061–18080 of 52,000 recalls

Medical DeviceSeptember 8, 2020· Aesculap Implant Systems LLC

Recalled Item: AESCULAP S4 Cervical Cross Connector L 28-33mm Recalled by Aesculap Implant...

The Issue: Insufficient clamping force of the cross connectors in the spinal surgical...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 8, 2020· Aesculap Implant Systems LLC

Recalled Item: AESCULAP S4 Cervical Cross Connector L 42-58mm Recalled by Aesculap Implant...

The Issue: Insufficient clamping force of the cross connectors in the spinal surgical...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 8, 2020· Aesculap Implant Systems LLC

Recalled Item: AESCULAP S4 Cervical Cross Connector L22mm Recalled by Aesculap Implant...

The Issue: Insufficient clamping force of the cross connectors in the spinal surgical...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2020· AB ULAX

Recalled Item: 1500 Flex Heat and Moisture Exchanger Recalled by AB ULAX Due to Firm has...

The Issue: Firm has received 6 complaints that the Heat Moisture Exchanger (HME)...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2020· Biomet, Inc.

Recalled Item: Biomet Regenerex Primary Taper Cap Item Number 141269 Recalled by Biomet,...

The Issue: Product not properly being aligned with the adequate gamma sterilization...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2020· Braxton Medical Corporation

Recalled Item: B. Braun Introcan IV Safety Catheters Recalled by Braxton Medical...

The Issue: Recalled products do not have FDA approval for sale in the United States.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2020· Biomet, Inc.

Recalled Item: Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055 Recalled by...

The Issue: Product not properly being aligned with the adequate gamma sterilization...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2020· Biomet, Inc.

Recalled Item: Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050 Recalled by Biomet,...

The Issue: Product not properly being aligned with the adequate gamma sterilization...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2020· Biomet, Inc.

Recalled Item: Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055 Recalled by Biomet, Inc....

The Issue: Product not properly being aligned with the adequate gamma sterilization...

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

Class II — Potential Health HazardOngoing
DrugSeptember 4, 2020· Teva Pharmaceuticals USA

Recalled Item: Buprenorphine Transdermal System 5 mcg/hour Recalled by Teva Pharmaceuticals...

The Issue: Failed Stability Specifications: Below specification result for...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 3, 2020· Akorn, Inc.

Recalled Item: Eye Itch Relief Recalled by Akorn, Inc. Due to CGMP Deviations

The Issue: CGMP Deviations

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
Medical DeviceSeptember 3, 2020· Biomet, Inc.

Recalled Item: (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar...

The Issue: Zimmer Biomet is conducting a medical device recall for three lots of the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 2, 2020· Biomet, Inc.

Recalled Item: Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper...

The Issue: Product potentially being packaged without a taper adapter or baseplate. The...

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

Class II — Potential Health HazardOngoing
DrugSeptember 2, 2020· pH-D Feminine Health

Recalled Item: pH-D Feminine Health Boric Acid Vaginal Suppositories Recalled by pH-D...

The Issue: Marketed without an Approved NDA/ANDA.

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugSeptember 1, 2020· The Protein Shoppe

Recalled Item: Red-E Tablet Recalled by The Protein Shoppe Due to Marketed Without An...

The Issue: Marketed Without An Approved NDA/ANDA: product found to be tainted with...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
Medical DeviceAugust 31, 2020· Biomet 3i, LLC

Recalled Item: CERTAIN BELLATEK TIN ABUTMENT 5.0MM Number: IEDAN5 Recalled by Biomet 3i,...

The Issue: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Ultradent Products, Inc.

Recalled Item: PermaFlo Flowable Composite 948 Shade: A2 - Product Usage: Recalled by...

The Issue: Due to a potential manufacturing issue (cross contamination), composite is...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2020· Vascular Solutions, Inc.

Recalled Item: Langston Dual Lumen Catheter. Recalled by Vascular Solutions, Inc. Due to...

The Issue: The inner lumen of the Langston catheter may separate from the hub during...

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

Class I — Serious Health HazardOngoing
Medical DeviceAugust 31, 2020· Vascular Solutions, Inc.

Recalled Item: Langston Dual Lumen Catheter. Recalled by Vascular Solutions, Inc. Due to...

The Issue: The inner lumen of the Langston catheter may separate from the hub during...

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

Class I — Serious Health HazardOngoing
Medical DeviceAugust 31, 2020· Biomet 3i, LLC

Recalled Item: BELLATEK TITANIUM ABUTMENT 4.1MM Number: EDAT4 Recalled by Biomet 3i, LLC...

The Issue: Hex of the BellaTek Encode Definitive Abutments was misaligned by 30 degrees...

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

Class II — Potential Health HazardOngoing