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. 2,598 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,598 in last 12 months

Showing 1778117800 of 29,188 recalls

Medical DeviceJuly 21, 2017· Fujifilm Medical Systems U.S.A., Inc.

Recalled Item: FUJINON ED-530XT. This device is intended for the visualization of Recalled...

The Issue: An update to the design and labeling was implemented to help reduce patient...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 21, 2017· Implant Direct Sybron Manufacturing, LLC

Recalled Item: Implant Direct Swish Duo-Grip Healing Collar Recalled by Implant Direct...

The Issue: The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 21, 2017· Howmedica Osteonics Corp.

Recalled Item: Accolade and Restoration hip product Recalled by Howmedica Osteonics Corp....

The Issue: Inner and outer sterile barriers not fully sealed.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 21, 2017· Helena Laboratories, Corp.

Recalled Item: SPIFE ImmunoFix-6 Kit Recalled by Helena Laboratories, Corp. Due to The...

The Issue: The plates do not have wells punched for the controls in the patient 1 area.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 21, 2017· Howmedica Osteonics Corp.

Recalled Item: Accolade and Restoration hip product Recalled by Howmedica Osteonics Corp....

The Issue: Inner and outer sterile barriers not fully sealed.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2017· Beckman Coulter Inc.

Recalled Item: Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K Recalled by Beckman...

The Issue: Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 19, 2017· Kamiya Biomedical Company, LLC

Recalled Item: K-Assay(R) Multi-Analyte Calibrator Recalled by Kamiya Biomedical Company,...

The Issue: The AlAT calibrator values in the package insert for the Multi-Analyte...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 19, 2017· Teleflex Medical

Recalled Item: Percuvance Maryland Dissector Tool Tip The Percutaneous Surgical System with...

The Issue: For some of the recalled products, the security of the connection between...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 19, 2017· Teleflex Medical

Recalled Item: Percuvance Clip Applier Tool Tip The Percutaneous Surgical System with...

The Issue: For some of the recalled products, the security of the connection between...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 19, 2017· Teleflex Medical

Recalled Item: Percuvance Gripper Grasper Tool Tip The Percutaneous Surgical System with...

The Issue: For some of the recalled products, the security of the connection between...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 19, 2017· Teleflex Medical

Recalled Item: Percuvance Scissors Tool Tip The Percutaneous Surgical System with 5mm...

The Issue: For some of the recalled products, the security of the connection between...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 19, 2017· Teleflex Medical

Recalled Item: Percuvance 29cm Shaft The Percutaneous Surgical System with 5mm attachments...

The Issue: For some of the recalled products, the security of the connection between...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 19, 2017· Teleflex Medical

Recalled Item: Percuvance Johans Grasper Tool Tip The Percutaneous Surgical System with...

The Issue: For some of the recalled products, the security of the connection between...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 19, 2017· Genicon, Inc.

Recalled Item: GENICON EZEE Retrieval Recalled by Genicon, Inc. Due to Plastic handle is...

The Issue: Plastic handle is breaking off of shaft inhibiting proper removal per...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 18, 2017· Roche Diagnostics Corporation

Recalled Item: cobas 8000 Modular Analyzer Series Recalled by Roche Diagnostics Corporation...

The Issue: A warning is being added to the cobas¿ 6000 analyzer and the cobas¿ 8000...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 18, 2017· Roche Diagnostics Corporation

Recalled Item: cobas 6000 Modular Series system Recalled by Roche Diagnostics Corporation...

The Issue: A warning is being added to the cobas¿ 6000 MODULAR Series System - c501 and...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 18, 2017· Medline Industries Inc

Recalled Item: Sterile Elastic Esmark Bandage Recalled by Medline Industries Inc Due to...

The Issue: Product did not undergo correct sterilization procedures and may potentially...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 18, 2017· Vyaire Medical

Recalled Item: AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER Recalled by Vyaire...

The Issue: Lot #0001047501 of the 9025RHTR ABG sampling kits have been manufactured...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 17, 2017· Maquet Datascope Corp - Cardiac Assist Division

Recalled Item: CS 100 Intra-Aortic Balloon Pump. It supports the heart's left Recalled by...

The Issue: False blood back detection alarm and the ingress of fluids into the IABP...

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

Class I — Serious Health HazardOngoing
Medical DeviceJuly 17, 2017· Maquet Datascope Corp - Cardiac Assist Division

Recalled Item: CS 300 Intra-Aortic Balloon Pump. It supports the heart's left Recalled by...

The Issue: False blood back detection alarm and the ingress of fluids into the IABP...

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

Class I — Serious Health HazardOngoing