Product Recalls in Kentucky

Product recalls affecting Kentucky — including food, drugs, consumer products, medical devices, and vehicles distributed to Kentucky. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,568 recalls have been distributed to Kentucky in the last 12 months.

51,386 total recalls
2,568 in last 12 months

Showing 1520115220 of 28,748 recalls

Medical DeviceSeptember 10, 2018· BioFire Diagnostics, LLC

Recalled Item: -Outer Kit Box (P/N RFIT-LBL-0140) - FilmArray¿ Meningitis/Encephalitis (ME)...

The Issue: Firm identified an issue in the manufacturing process which might contribute...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 10, 2018· Howmedica Osteonics Corp.

Recalled Item: Sterile Knee Instruments Disposable Fluted Headless Pins Recalled by...

The Issue: Potential for outer pouch sterile barrier to be compromised

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: VALITUDE 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 10, 2018· Boston Scientific Corporation

Recalled Item: PROPONENT 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: ACCOLADE 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: 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 9, 2018· Vivorte, Inc.

Recalled Item: Vivorte Trabexus EB 10 cc Bone Void Filler -Fill bone Recalled by Vivorte,...

The Issue: incorrect expiration date- product is listed with 02-15-2019 the correct kit...

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· 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