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. 2,664 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,664 in last 12 months

Showing 1100111020 of 29,188 recalls

Medical DeviceOctober 7, 2020· Steris Corporation

Recalled Item: Olympus Leak Test Adapter used with Acu-sInQ Complete Endoscope Cleaning...

The Issue: Potential for cleaning solution intrusion into endoscope

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

Class III — Low RiskOngoing
Medical DeviceOctober 6, 2020· Arjohuntleigh Magog, Inc.

Recalled Item: Arjo Flat Dynamic Positioning System (DPS) - Product Usage: used Recalled by...

The Issue: Risk of Sling Clip breakage while in use with obsolete Flat Dynamic...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 6, 2020· Exactech, Inc.

Recalled Item: Catalog 314-13-23 Recalled by Exactech, Inc. Due to Mislabeling

The Issue: The product may be mislabeled.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 6, 2020· Exactech, Inc.

Recalled Item: Catalog 314-13-33 Recalled by Exactech, Inc. Due to Mislabeling

The Issue: The product may be mislabeled.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 5, 2020· Thera Test Laboratories, Inc.

Recalled Item: EL-Anti-SARS-CoV-2 IgG Kit Recalled by Thera Test Laboratories, Inc. Due to...

The Issue: The cross-reactivity of the device may present an increased level of...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 5, 2020· Becton, Dickinson and Company, BD Biosciences

Recalled Item: BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Recalled by Becton,...

The Issue: Recent product complaints showing an unexpected cell population exhibiting...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 5, 2020· Bayer Medical Care, Inc.

Recalled Item: Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic...

The Issue: Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 5, 2020· Micro-Tech Usa

Recalled Item: Elastic Traction Device Recalled by Micro-Tech Usa Due to FDA has informed...

The Issue: FDA has informed Micro-Tech that the Elastic Traction Device is not...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2020· Microbiologics Inc

Recalled Item: KWIK-STIK(TM) Recalled by Microbiologics Inc Due to Potential E. coli...

The Issue: Potential contamination with S. epidermidis E. coli and S. warneri.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2020· Microbiologics Inc

Recalled Item: QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Recalled by...

The Issue: Potential contamination with Escherichia coli Staphylococcus epidermidis and...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2020· Microbiologics Inc

Recalled Item: LYFO DISK(TM) Recalled by Microbiologics Inc Due to Potential E. coli...

The Issue: Potential contamination with Escherichia coli, Staphylococcus epidermidis...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2020· Epitope Diagnostics, Inc.

Recalled Item: EDI Novel Coronavirus COVID-19 IgG ELISA Kit Recalled by Epitope...

The Issue: The use of deionized water rather than distilled water during the...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 1, 2020· Bard Peripheral Vascular Inc

Recalled Item: Bard Conquest PTA Balloon dilation Catheter Recalled by Bard Peripheral...

The Issue: Dilation catheter packaged with the wrong size balloon. The labeling states...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 30, 2020· Ortho Clinical Diagnostics Inc

Recalled Item: VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product...

The Issue: Elevated sample results signal/cutoff (s/c) values when using eight (8) lots...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 30, 2020· Ortho Clinical Diagnostics Inc

Recalled Item: VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage:...

The Issue: Elevated sample results signal/cutoff (s/c) values when using eight (8) lots...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 30, 2020· Merz North America, Inc.

Recalled Item: COAPTITE Injectable Implant Recalled by Merz North America, Inc. Due to The...

The Issue: The Instructions for Use (IFU) updated 03/02/2020 does not match data listed...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 30, 2020· Maquet Cardiovascular Us Sales, Llc

Recalled Item: Blood Monitoring Unit (BMU 40) Recalled by Maquet Cardiovascular Us Sales,...

The Issue: The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 29, 2020· Verathon, Inc.

Recalled Item: BladderScan Prime Plus Probe - Product Usage: intended Recalled by Verathon,...

The Issue: Due to a change in handle material and process, probe handle may crack.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 26, 2020· Advanced Bionics, LLC

Recalled Item: AB PowerCel 170 (velvet black) Recalled by Advanced Bionics, LLC Due to...

The Issue: Mislabeling; It has been determined that some batteries were improperly...

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

Class III — Low RiskOngoing
Medical DeviceSeptember 26, 2020· Advanced Bionics, LLC

Recalled Item: AB PowerCel 230 (velvet black) Recalled by Advanced Bionics, LLC Due to...

The Issue: Mislabeling; It has been determined that some batteries were improperly...

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

Class III — Low RiskOngoing