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 1098111000 of 29,188 recalls

Medical DeviceOctober 16, 2020· Olympus Corporation of the Americas

Recalled Item: Olympus Ultrasound Endoscope Recalled by Olympus Corporation of the Americas...

The Issue: A new inspection step was added to the cleaning and disinfection section of...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 16, 2020· Olympus Corporation of the Americas

Recalled Item: Olympus Ultrasound Endoscope Recalled by Olympus Corporation of the Americas...

The Issue: A new inspection step was added to the cleaning and disinfection section of...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 16, 2020· Olympus Corporation of the Americas

Recalled Item: Olympus Ultrasound Endoscope Recalled by Olympus Corporation of the Americas...

The Issue: A new inspection step was added to the cleaning and disinfection section of...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 16, 2020· Ortho Clinical Diagnostics Inc

Recalled Item: VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic...

The Issue: Product instability; biased ALKP values obtained from VITROS Chemistry...

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

Class III — Low RiskOngoing
Medical DeviceOctober 16, 2020· Covidien Llc

Recalled Item: Puritan Bennett 980 (PB980) Ventilator Series - Product Usage: for Recalled...

The Issue: In-house lab observations and customer reports of overheating and/or thermal...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 16, 2020· Stryker Instruments Div. of Stryker Corporation

Recalled Item: Stryker Zyphr Disposable Cranial Perforator Recalled by Stryker Instruments...

The Issue: Potential for the inner bit to contain a crack, that may or may not be...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 14, 2020· Angiodynamics, Inc.

Recalled Item: Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous...

The Issue: 5F Micro-Introducer Kits may not contain the correct device, packaged with a...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 13, 2020· Luminex Corporation

Recalled Item: Verigene Processor SP Recalled by Luminex Corporation Due to Luminex has...

The Issue: Luminex has determined that three (3) separate test fixtures used by field...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 13, 2020· Luminex Corporation

Recalled Item: Verigene Processor SP Recalled by Luminex Corporation Due to Luminex has...

The Issue: Luminex has determined that three (3) separate test fixtures used by field...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 12, 2020· ROi CPS LLC

Recalled Item: Regard - Product Usage: Obstetric Gynecologic specialized manual instrument....

The Issue: Labeling error, incorrect expiration date.

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 12, 2020· MEDTRONIC ATS MEDICAL, INC.

Recalled Item: Cardioblate CryoFlex Recalled by MEDTRONIC ATS MEDICAL, INC. Due to There is...

The Issue: There is a potential defect in the seals of the sterile barrier pouch used...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 12, 2020· MEDTRONIC ATS MEDICAL, INC.

Recalled Item: Cardioblate CryoFlex Recalled by MEDTRONIC ATS MEDICAL, INC. Due to There is...

The Issue: There is a potential defect in the seals of the sterile barrier pouch used...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 12, 2020· MEDTRONIC ATS MEDICAL, INC.

Recalled Item: Cardioblate CryoFlex Recalled by MEDTRONIC ATS MEDICAL, INC. Due to There is...

The Issue: There is a potential defect in the seals of the sterile barrier pouch used...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 12, 2020· MEDTRONIC ATS MEDICAL, INC.

Recalled Item: Cardioblate CryoFlex Recalled by MEDTRONIC ATS MEDICAL, INC. Due to There is...

The Issue: There is a potential defect in the seals of the sterile barrier pouch used...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 9, 2020· Talladium Inc

Recalled Item: Luminesse ML PMMA Recalled by Talladium Inc Due to Heat-cured...

The Issue: Heat-cured polymethylmethacrylate (PMMA) milling blank product used to make...

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

Class III — Low RiskOngoing
Medical DeviceOctober 9, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: cobas infinity central lab/cobas infinity core license-The cobas infinity IT...

The Issue: Potential Incorrect Validation of Results Due to an Erroneous QC Status When...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 8, 2020· Enterix, Inc.

Recalled Item: InSure ONE Test Strips (25 pack) vials-fecal immunochemical test (FIT)...

The Issue: Product does not meet internal testing criterion; use of the product may...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 8, 2020· Canon Medical System, USA, INC.

Recalled Item: CAS-930A Flat Panel Monitor (FPD) used in conjunction with the Recalled by...

The Issue: There is a potential that the cable of the Flat panel detector may break...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 8, 2020· RAYSEARCH LABORATORIES AB

Recalled Item: RayStation standalone software treatment planning system Recalled by...

The Issue: If a region of interest (ROI) or point of interest (POI) that is from an...

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

Class II — Potential Health HazardOngoing
Medical DeviceOctober 8, 2020· Microbiologics Inc

Recalled Item: Catalog 02145P Recalled by Microbiologics Inc Due to Strain should be VIM-1...

The Issue: Strain should be VIM-1 positive but is confirmed to be VIM-1 negative.

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

Class II — Potential Health HazardOngoing