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. 2,457 recalls have been distributed to Kentucky in the last 12 months.

51,386 total recalls
2,457 in last 12 months

Showing 2508125100 of 28,748 recalls

Medical DeviceJanuary 21, 2014· Dako North America Inc.

Recalled Item: Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109 Recalled by...

The Issue: Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 20, 2014· GE Healthcare, LLC

Recalled Item: GE Healthcare Precision 500D and Proteus XR/a equipped with Wireless...

The Issue: GE Healthcare has recently become aware of a software issue associated with...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 20, 2014· Edwards Lifesciences, LLC

Recalled Item: Crimper Model 9100CR26 The Crimper is indicated for use in Recalled by...

The Issue: Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 20, 2014· Horiba Instruments, Inc dba Horiba Medical

Recalled Item: ABX PENTRA Multical. ABX PENTRA N Control. ABX PENTRA P Recalled by Horiba...

The Issue: HORIBA Medical is informing all ABX PENTRA MultiCal, N Control, and P...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 17, 2014· Medical Information Technology, Inc.

Recalled Item: MEDITECH Microbiology - Calculator/data processing module Recalled by...

The Issue: Potential for patient results being removed from LAB/EMR.

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 16, 2014· CareFusion 303, Inc.

Recalled Item: Trifurcated Extension Set Recalled by CareFusion 303, Inc. Due to CareFusion...

The Issue: CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 15, 2014· Ortho-Clinical Diagnostics

Recalled Item: VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators Recalled...

The Issue: Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic...

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

Class III — Low RiskOngoing
Medical DeviceJanuary 14, 2014· Instrumentarium Dental, PaloDEx Group Oy

Recalled Item: The FOCUS is a microprocessor controlled intra-oral x-ray unit with Recalled...

The Issue: Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2014· Philips Healthcare

Recalled Item: InnerCool RTx Endovascular System Recalled by Philips Healthcare Due to...

The Issue: Phillips Healthcare initiated this action because the Main Control Board...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 13, 2014· Accuray Incorporated

Recalled Item: Accuray CyberKnife Robotic Radiosurgery System Recalled by Accuray...

The Issue: Potential Safety issue with Synchrony Boom Arm Mounting Assembly - one...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 10, 2014· Leica Microsystems, Inc.

Recalled Item: Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15) Recalled by Leica...

The Issue: Product does not function as intended up to the expiry date on the product...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 10, 2014· Focus Diagnostics Inc

Recalled Item: Simplexa Flu A/B & RSV Direct assay Recalled by Focus Diagnostics Inc Due to...

The Issue: Focus Diagnostics is initiating an urgent safety notice correction for...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 10, 2014· Tandem Diabetes Care Inc

Recalled Item: T:slim Insulin Delivery System Insulin Infusion Pump Recalled by Tandem...

The Issue: Specific lots of insulin cartridges that are used with the T:slim Insulin...

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

Class I — Serious Health HazardOngoing
Medical DeviceJanuary 9, 2014· Smith & Nephew Inc.

Recalled Item: Smith & Nephew RENASYS-F XL with Soft Port REF #: Recalled by Smith & Nephew...

The Issue: Reports of wound fluid and /or blood that were not evacuated from beneath...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 9, 2014· Smith & Nephew Inc.

Recalled Item: Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794...

The Issue: Reports of wound fluid and /or blood that were not evacuated from beneath...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 9, 2014· Smith & Nephew Inc.

Recalled Item: Smith & Nephew RENASYS Soft Port (The RENASYS Recalled by Smith & Nephew...

The Issue: Reports of wound fluid and /or blood that were not evacuated from beneath...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 9, 2014· Mako Surgical Corporation

Recalled Item: Restoris Multicompartmental Knee (MCK) System is an implant system designed...

The Issue: The product may be mislabeled and could result in the incorrect implant...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 9, 2014· Smith & Nephew Inc.

Recalled Item: Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port Recalled by...

The Issue: Reports of wound fluid and /or blood that were not evacuated from beneath...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 9, 2014· Medtronic Cardiovascular Surgery-the Heart Valve Division

Recalled Item: Product Name: Model 7305- Mosaic Aortic Obturator The Mosaic Aortic Recalled...

The Issue: Medtronic, Inc. initiated a recall of Medtronic Mosaic Aortic Obturator...

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

Class II — Potential Health HazardOngoing
Medical DeviceJanuary 9, 2014· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products White Slides Recalled by Ortho-Clinical...

The Issue: An incorrect assay value (0.3785) was printed on the product carton for the...

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

Class II — Potential Health HazardOngoing