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. 2,536 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,536 in last 12 months

Showing 2132121340 of 29,188 recalls

Medical DeviceJanuary 15, 2016· Mako Surgical Corporation

Recalled Item: Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for...

The Issue: Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2016· OraSure Technologies, Inc.

Recalled Item: OraQuick HCV Visual Panel Intended to assist new operation Recalled by...

The Issue: OraSure Technologies, Inc. discovered the package insert included with the...

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

Class III — Low RiskOngoing
Medical DeviceJanuary 15, 2016· Spectranetics Corp.

Recalled Item: 2.3mm Turbo-Power OTW Recalled by Spectranetics Corp. Due to The product is...

The Issue: The product is labeled with an expiration date that is past its shelf life.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 14, 2016· Siemens Healthcare Diagnostics, Inc.

Recalled Item: BCS XP Automated Blood Coagulation Analyzer System Recalled by Siemens...

The Issue: False short clotting times for PT on BCS and BCS XP with Dade Innovin can...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 14, 2016· Toshiba American Medical Systems Inc

Recalled Item: Toshiba DRAD-3000E FPD Wireless System Product Usage The DRAD-3000¿ is...

The Issue: When a user performed radiography using the wireless FPD, a message window...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 14, 2016· Siemens Healthcare Diagnostics, Inc.

Recalled Item: BCS Automated Blood Coagulation Analyzer System Recalled by Siemens...

The Issue: False short clotting times for PT on BCS and BCS XP with Dade Innovin can...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2016· Siemens Healthcare Diagnostics, Inc

Recalled Item: Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number:...

The Issue: The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2016· Siemens Healthcare Diagnostics, Inc

Recalled Item: Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 Recalled...

The Issue: The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2016· Siemens Healthcare Diagnostics, Inc

Recalled Item: IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22 Recalled by...

The Issue: The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2016· Olympus Scientific Solutions Americas

Recalled Item: Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF...

The Issue: The Firm has discovered a Software bug.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2016· PMBS, LLC

Recalled Item: The S.C.O.R.E.S. Unit (self contained operating room equipment sterilization...

The Issue: Water retention issues. Units with filters that remain wet after the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2016· Siemens Healthcare Diagnostics, Inc

Recalled Item: IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21 Recalled by...

The Issue: The drug fulvestrant (Faslodex¿) may cause falsely elevated estradiol results.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2016· Resmed Corporation

Recalled Item: Astral 100 Recalled by Resmed Corporation Due to Resmed Corporation is...

The Issue: Resmed Corporation is recalling Astral 100, 150 External Battery because of...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 12, 2016· Arrow International Inc

Recalled Item: Super Arrow-Flex Percutaneous Sheath Introducer Sets or CL-07635 Recalled by...

The Issue: Arrow has issued a recall for these products due to potential packaging...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 11, 2016· Zimmer Biomet, Inc.

Recalled Item: Bipolar Shell prosthesis Recalled by Zimmer Biomet, Inc. Due to LDPE bag...

The Issue: LDPE bag containing the implant adheres to the highly polished implant surface.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 11, 2016· Medtronic Neuromodulation

Recalled Item: Specify 5-6-5 Lead Recalled by Medtronic Neuromodulation Due to Some Specify...

The Issue: Some Specify 5-6-5 and 2x8 surgical lead product labeling does not...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 11, 2016· Zimmer Biomet, Inc.

Recalled Item: NKII CSTI Porous Femoral NKII NP Femoral prosthesis Recalled by Zimmer...

The Issue: LDPE bag containing the implant adheres to the highly polished implant surface.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 11, 2016· Leica Microsystems, Inc.

Recalled Item: Leica Microsystems (Schweiz) Ag. The common name of the device Recalled by...

The Issue: An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 11, 2016· Zimmer Biomet, Inc.

Recalled Item: CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral Recalled by Zimmer...

The Issue: LDPE bag containing the implant adheres to the highly polished implant surface.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 11, 2016· Zimmer Biomet, Inc.

Recalled Item: CPT 12/14 COCR prosthesis Recalled by Zimmer Biomet, Inc. Due to LDPE bag...

The Issue: LDPE bag containing the implant adheres to the highly polished implant surface.

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

Class II — Potential Health HazardOngoing