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. 2,492 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,492 in last 12 months

Showing 2806128080 of 29,188 recalls

Medical DeviceSeptember 13, 2012· Zimmer, Inc.

Recalled Item: CPT Hip System Femoral Stem Petite Recalled by Zimmer, Inc. Due to Zimmer...

The Issue: Zimmer Inc. is initiating a removal of the CPT Modular Stem (item...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2012· Philips Healthcare Inc.

Recalled Item: Philips Digital Diagnost with patient carriage Model: 712050 with serial...

The Issue: Hook does not securely hold the footplate in vertical position, causing the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2012· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Magnetom Skyra Recalled by Siemens Medical Solutions USA, Inc Due to...

The Issue: When positioning the Flex Large 4 Coil (part No. 8625761) off-center in...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2012· Mako Surgical Corporation

Recalled Item: The RIO (TGS 2.) Recalled by Mako Surgical Corporation Due to MAKO Surgical...

The Issue: MAKO Surgical Group recalled their RIO System software, version 2.4 and is...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 11, 2012· Philips Healthcare Inc.

Recalled Item: Philips HeartStart XL M4735A Defibrillator/Monitors Recalled by Philips...

The Issue: HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 11, 2012· Siemens Healthcare Diagnostics, Inc

Recalled Item: Siemens ADVIA Centaur BR Assay: Catalog Number: US: Recalled by Siemens...

The Issue: BR Assay for CA 27.29 Calibration Interval Change due quality control (QC)...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 11, 2012· Philips Medical Systems (Cleveland) Inc

Recalled Item: Computed Tomography X-Ray System Brilliance Workspace Portal Recalled by...

The Issue: Philips was notified that when performing post processing with the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 10, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: Recalled...

The Issue: Terumo Cardiovascular Systems (CVS) received two reports of the false back...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 10, 2012· Invacare Corporation

Recalled Item: Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility...

The Issue: The potential exists for the wheel to rotate freely despite engagement of...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2012· Zimmer, Inc.

Recalled Item: Cemented Tibial Drill Product Usage: The cemented tibial drill is Recalled...

The Issue: Zimmer is initiating a recall of the Cemented Tibial Drill for the Zimmer...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2012· Baxter Healthcare Corp.

Recalled Item: Baxter Interlink System Buretrol Solution Set with 150 mL Burette Recalled...

The Issue: Baxter has determined that the ball-valve feature of the Buretrol Solution...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 7, 2012· Baxter Healthcare Corp.

Recalled Item: Baxter Clearlink System Buretrol Solution Set Recalled by Baxter Healthcare...

The Issue: Baxter has determined that the ball-valve feature of the Buretrol Solution...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 7, 2012· Baxter Healthcare Corp.

Recalled Item: Baxter Clearlink System Buretrol Solution Set Recalled by Baxter Healthcare...

The Issue: Baxter has determined that the ball-valve feature of the Buretrol Solution...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 7, 2012· C.R. Bard, Inc., Urological Division

Recalled Item: 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc Recalled by...

The Issue: The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2012· Baxter Healthcare Corp.

Recalled Item: Baxter Interlink System Buretrol Solution Set Recalled by Baxter Healthcare...

The Issue: Baxter has determined that the ball-valve feature of the Buretrol Solution...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 7, 2012· Optovue Inc.

Recalled Item: materials "RETINAL OCT Analysis and Interpretation Method" shipped with...

The Issue: Devices labeled for an intended use not included in the existing 510(k) or...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2012· Instrumentation Industries Inc

Recalled Item: Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators...

The Issue: Firm initiated an update to Directions for Use necessitating replacement of...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2012· Synthes USA HQ, Inc.

Recalled Item: Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw...

The Issue: This action is being initiated following a detailed investigation in...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2012· Synthes USA HQ, Inc.

Recalled Item: Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap...

The Issue: This action is being initiated following a detailed investigation in...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 6, 2012· DePuy Mitek, Inc., a Johnson & Johnson Co.

Recalled Item: SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number:...

The Issue: Fracture of SPIRALOK Anchors post op, requiring patient revision

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

Class II — Potential Health HazardOngoing