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. 2,636 recalls have been distributed to Tennessee in the last 12 months.

52,000 total recalls
2,636 in last 12 months

Showing 1540115420 of 29,188 recalls

Medical DeviceSeptember 10, 2018· Boston Scientific Corporation

Recalled Item: ESSENTIO Pacemaker Recalled by Boston Scientific Corporation Due to Boston...

The Issue: Boston Scientific has identified a subset of active pacemaker and CRT-Ps...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 10, 2018· Boston Scientific Corporation

Recalled Item: Model 3300 LATITUDE(TM) Programming System Product Usage - The Boston...

The Issue: There is a potential for the Pacing System Analyzer (PSA) to exhibit...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 10, 2018· Boston Scientific Corporation

Recalled Item: VISIONIST X4 CRT-P (Cardiac Resynchronization Therapy Pacemaker) Recalled by...

The Issue: Boston Scientific has identified a subset of active pacemaker and CRT-Ps...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2018· Vital Scientific N.V.

Recalled Item: V-Twin Recalled by Vital Scientific N.V. Due to The action is being...

The Issue: The action is being initiated because the cooling indicator board was...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2018· Abbott Laboratories, Inc

Recalled Item: APS Accelerator modular systems Recalled by Abbott Laboratories, Inc Due to...

The Issue: The firm identified customer sites where modules which the safety pacemaker...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2018· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Vista Lipase Flex Reagent Cartridge Recalled by Siemens Healthcare...

The Issue: There is lot to lot variability for QC and patient results when using the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2018· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Dimension Lipase Flex Reagent Cartridge Recalled by Siemens Healthcare...

The Issue: There is lot to lot variability for QC and patient results when using the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2018· Bayer Medical Care, Inc.

Recalled Item: Codan Filter (Codan catalog number BC 693) used with Medrad Recalled by...

The Issue: Bayer has received reports of loose particulate in the filter when the dust...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 6, 2018· Stihler Electronic Gmbh

Recalled Item: Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Recalled...

The Issue: PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 6, 2018· Stihler Electronic Gmbh

Recalled Item: Heating Profile PRISMAFLO II S blood return warmer for Prismaflex Recalled...

The Issue: PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 6, 2018· Stihler Electronic Gmbh

Recalled Item: Heating Profile PRISMAFLO II blood return warmer for Prismaflex Product...

The Issue: PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 6, 2018· Stryker Medical Division of Stryker Corporation

Recalled Item: Altrix¿ Precision Temperature Management System Model: 8001Product Usage:...

The Issue: Users may experience alarm fatigue due to frequent alarming relating to...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 6, 2018· CryoLife, Inc.

Recalled Item: CryoPatch SG Pulmonary Hemi-Artery Recalled by CryoLife, Inc. Due to The...

The Issue: The conduit length and branch length of a SG Pulmonary Hemi-Artery were...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 5, 2018· Cordis Corporation

Recalled Item: Cordis POWERFLEX PRO PTA Dilatation Catheter - Product Usage: Is Recalled by...

The Issue: Product may not meet the internal manufacturing shaft subassembly burst...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 5, 2018· BioFire Diagnostics, LLC

Recalled Item: FilmArray Blood Culture Identification (BCID) Recalled by BioFire...

The Issue: Increased risk of false positive results for Proteus when the product is...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 5, 2018· Thoratec Switzerland GMBH

Recalled Item: Thoratec CentriMag Motor Recalled by Thoratec Switzerland GMBH Due to...

The Issue: Reports of circulatory support system motor stopping. Motor stop can be...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2018· Alpha Omega Engineering

Recalled Item: Neuro Omega System Recalled by Alpha Omega Engineering Due to If cables are...

The Issue: If cables are improperly connected, current may reach high charge density,...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 4, 2018· Philips Medical Systems (Cleveland) Inc

Recalled Item: Vereos PET/CT Recalled by Philips Medical Systems (Cleveland) Inc Due to...

The Issue: Software Correction: Software errors that may result in incorrect 4D CT...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2018· Cypress Medical Products LLC

Recalled Item: McKesson Insulin Syringe 0.3mL 31GX5/16 Item Numbers: 102-SN310C31516P...

The Issue: Small hole at the end of the syringe is impeding suction of liquid.

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 4, 2018· CooperSurgical, Inc.

Recalled Item: Colpo-Pneumo Occluder Recalled by CooperSurgical, Inc. Due to The seal of...

The Issue: The seal of the sterile pouch may be compromised, thereby increasing the...

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

Class II — Potential Health HazardOngoing