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. 2,603 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,603 in last 12 months

Showing 1754117560 of 29,188 recalls

Medical DeviceSeptember 5, 2017· Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Recalled Item: Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ Recalled by...

The Issue: Lack of sterility assurance: leaking containers which could lead to exposure...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 5, 2017· Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company

Recalled Item: Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿ Recalled by Medex...

The Issue: Lack of sterility assurance: leaking containers which could lead to exposure...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 1, 2017· Respire Medical

Recalled Item: Respire Pink Series EF+ Oral Sleep Apnea Device. Recalled by Respire Medical...

The Issue: Potential for device breakage during use

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 1, 2017· Respire Medical

Recalled Item: Respire Pink+ Hard/Soft Oral Sleep Apnea Device Recalled by Respire Medical...

The Issue: Potential for device breakage during use

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 1, 2017· Respire Medical

Recalled Item: Respire Pink H/S Oral Sleep Apnea Device Recalled by Respire Medical Due to...

The Issue: Potential for device breakage during use

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 1, 2017· Respire Medical

Recalled Item: Respire Pink+ Hard Oral Sleep Apnea Device Recalled by Respire Medical Due...

The Issue: Potential for device breakage during use

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 1, 2017· Aesculap Implant Systems LLC

Recalled Item: The ELAN 4 Air System is intended for high speed cutting Recalled by...

The Issue: The ELAN 4 Air System was released to the market place prior to an...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 1, 2017· Respire Medical

Recalled Item: Respire Pink H/S Oral Sleep Apnea Device Recalled by Respire Medical Due to...

The Issue: Potential for device breakage during use

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 1, 2017· Aaren Scientific Inc.

Recalled Item: AERO IOL Injection System containing 10 Z28 Cartridges per box Recalled by...

The Issue: The recommended storage temperature on the label is incorrect.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 1, 2017· Elekta Inc

Recalled Item: Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments....

The Issue: Incorrect DICOM mapping of the exported collimator or couch angles from...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 1, 2017· Permobil, Ab

Recalled Item: Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II Recalled by...

The Issue: There is a potential failure of the top plate assembly, which is the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 1, 2017· Baxter Healthcare Corp

Recalled Item: Baxter Amia Automated Peritoneal Dialysis Set with Cassette Recalled by...

The Issue: The firm received increased customer complaints for Missing Red Line,...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 1, 2017· Permobil, Ab

Recalled Item: Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500 Recalled by...

The Issue: There is a potential failure of the top plate assembly, which is the...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2017· Siemens Medical Solutions USA, Inc

Recalled Item: Syngo.via systems with SW VB20A Recalled by Siemens Medical Solutions USA,...

The Issue: A software update was released on August 22, 2017. Performing this software...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2017· Exactech, Inc.

Recalled Item: Equinoxe Cage Recalled by Exactech, Inc. Due to Mislabeling

The Issue: Potentially mislabeled.

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2017· Orthoscan, Inc.

Recalled Item: Mobile Mini C-arm system Part # 1000-0004-FD. Intended to provide Recalled...

The Issue: OrthoScan Inc. discovered during investigation of a non-standard work flow a...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2017· Orthoscan, Inc.

Recalled Item: Mobile Mini C-arm system Part # 1000-0004. Intended to provide Recalled by...

The Issue: OrthoScan Inc. discovered during investigation of a non-standard work flow a...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2017· Orthoscan, Inc.

Recalled Item: Mobile Mini C-arm system Part # 1000-0001. Intended to provide Recalled by...

The Issue: OrthoScan Inc. discovered during investigation of a non-standard work flow a...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2017· Orthoscan, Inc.

Recalled Item: Mobile Mini C-arm system Part # 1000-0005. Intended to provide Recalled by...

The Issue: OrthoScan Inc. discovered during investigation of a non-standard work flow a...

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

Class II — Potential Health HazardOngoing
Medical DeviceAugust 31, 2017· DePuy Mitek, Inc., a Johnson & Johnson Co.

Recalled Item: 1113 Gravity Tube Set Pk/24 -SH Product Usage: The FMS Recalled by DePuy...

The Issue: Leakage of FMS gravity tub sets (281113) at the bulb and tube connection

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

Class II — Potential Health HazardOngoing