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. 2,582 recalls have been distributed to Kentucky in the last 12 months.

51,386 total recalls
2,582 in last 12 months

Showing 1448114500 of 28,748 recalls

Medical DeviceMarch 7, 2019· Stryker Corporation

Recalled Item: Stryker Heated Tube Set with Real-Time Pressure Sensing (RTP) Recalled by...

The Issue: The heated tube sets were consistently leaking and detaching from the cassette.

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 7, 2019· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica IM 1600 Analyzer Recalled by Siemens Healthcare Diagnostics, Inc....

The Issue: There were multiple issues identified in the system software which required...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 7, 2019· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica Sample Handler Prime Recalled by Siemens Healthcare Diagnostics,...

The Issue: There were multiple issues identified in the system software which required...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 7, 2019· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica IM 1300 Analyzer Recalled by Siemens Healthcare Diagnostics, Inc....

The Issue: There were multiple issues identified in the system software which required...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 7, 2019· BioFire Diagnostics, LLC

Recalled Item: FilmArray BCID Panel Recalled by BioFire Diagnostics, LLC Due to Potential...

The Issue: Increased risk of false positive Enterobacteriaceae and Escherichia coli...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 6, 2019· BioFire Diagnostics, LLC

Recalled Item: FilmArray Gastrointestinal (GI) Panel Recalled by BioFire Diagnostics, LLC...

The Issue: Elevated rates of false positive results for Campylobacter and...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 6, 2019· Topcon Medical Systems, Inc.

Recalled Item: IMAGEnet 6 v1.53- IMAGEnet 6 Ophthalmic Data System is a Recalled by Topcon...

The Issue: When a patient is selected in the patient data and another patient is...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 6, 2019· PROCEPT BIOROBOTICS CORPORATION

Recalled Item: AquaBeam Handpiece Recalled by PROCEPT BIOROBOTICS CORPORATION Due to...

The Issue: Certain lots may develop an internal leak due to a micro-crack in a specific...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 5, 2019· Fenwal Inc

Recalled Item: Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled...

The Issue: Based on internal investigations, Fresenius Kabi has identified a...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 1, 2019· Thoratec Corp.

Recalled Item: Thoratec HeartMate 3 Coring Tool Recalled by Thoratec Corp. Due to Small...

The Issue: Small black plastic particle was observed in the left ventricle during...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 1, 2019· Integra Limited

Recalled Item: Integra bioBLOCK Resorbable subtaler Implant Recalled by Integra Limited Due...

The Issue: Temperature indicator may have changed color to dark gray or black prior to...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 1, 2019· Integra Limited

Recalled Item: Integra bioBLOCK Resorbable subtaler Implant Recalled by Integra Limited Due...

The Issue: Temperature indicator may have changed color to dark gray or black prior to...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 1, 2019· Integra Limited

Recalled Item: Integra bioBLOCK Resorbable subtaler Implant Recalled by Integra Limited Due...

The Issue: Temperature indicator may have changed color to dark gray or black prior to...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 1, 2019· Zimmer Biomet, Inc.

Recalled Item: Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile...

The Issue: Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 1, 2019· Zimmer Biomet, Inc.

Recalled Item: Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile...

The Issue: Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have...

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

Class II — Potential Health HazardOngoing
Medical DeviceMarch 1, 2019· Medical Action Industries Inc

Recalled Item: Laparotomy Sponge with the following product description and model numbers:...

The Issue: Potential lack of sterility assurance

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 28, 2019· Becton Dickinson & Company

Recalled Item: SmartSite Syringe Administration Set-Product Package Size 50 Recalled by...

The Issue: Leaking of the Smartsite Syringe Administration Set. May result in delay or...

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

Class I — Serious Health HazardOngoing
Medical DeviceFebruary 28, 2019· Zimmer Biomet, Inc.

Recalled Item: Biomet Small Diameter Cement Plug Inserter-Sterile Recalled by Zimmer...

The Issue: Lack of an adequate sterilization validation

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 28, 2019· Philips North America, LLC

Recalled Item: MultiDiagnost-Eleva Recalled by Philips North America, LLC Due to The...

The Issue: The locking plate may be missing from the system, which may result in...

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

Class II — Potential Health HazardOngoing
Medical DeviceFebruary 28, 2019· Philips North America, LLC

Recalled Item: Omnidiagnost Classic Recalled by Philips North America, LLC Due to The...

The Issue: The locking plate may be missing from the system, which may result in...

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

Class II — Potential Health HazardOngoing