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. 2,483 recalls have been distributed to Kentucky in the last 12 months.

51,386 total recalls
2,483 in last 12 months

Showing 2132121340 of 28,748 recalls

Medical DeviceDecember 21, 2015· Therakos Inc

Recalled Item: The THERAKOS CELLEX Photopheresis System is a photoimmune therapy. Catalog...

The Issue: The Mallinckrodt (Therakos) post-market monitoring process detected an...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Arjo, Inc. dba ArjoHuntleigh

Recalled Item: The Concerto Basic Shower Trolley is intended for assisted hygiene care...

The Issue: Reports of the bolts connecting the stretcher to the hydraulic piston and...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 21, 2015· Northeast Laboratory Services, Inc.

Recalled Item: NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.:...

The Issue: Product marketed without a 510 (k)

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· Arkray Factory USA, Inc.

Recalled Item: arkray SPOTCHEM II Glucose Reagent test strips Recalled by Arkray Factory...

The Issue: One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 18, 2015· NeoCoil, LLC

Recalled Item: NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil Recalled by NeoCoil, LLC...

The Issue: Potential for higher than specified surface temperatures. Use of 3.0T GEM...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· Elekta, Inc.

Recalled Item: Oncentra External Beam - VMAT - Radiation therapy planning system Recalled...

The Issue: When using the option "Tumor Overlap Fraction" in VMAT planning it has been...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· C.R. Bard, Inc.

Recalled Item: BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary...

The Issue: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· C.R. Bard, Inc.

Recalled Item: BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter Recalled by C.R. Bard,...

The Issue: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· C.R. Bard, Inc.

Recalled Item: BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter Recalled by C.R....

The Issue: Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· Stryker Spine

Recalled Item: Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine...

The Issue: Reported jamming of the impaction handle when assembled to the Inserter...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· Arkray Factory USA, Inc.

Recalled Item: arkray SPOTCHEM II Basic Panel - 1 Reagent test strips Recalled by Arkray...

The Issue: One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 18, 2015· EndoChoice, Inc.

Recalled Item: Fuse 1C Colonoscope Recalled by EndoChoice, Inc. Due to The bending section...

The Issue: The bending section of the device may partially separate from the insertion...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2015· GE Medical Systems, LLC

Recalled Item: Mavig Monitor Suspension System Recalled by GE Medical Systems, LLC Due to...

The Issue: GE Healthcare has recently become aware of a reported incident in which a...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: BrightView X are gamma cameras Recalled by Philips Medical Systems...

The Issue: The firm discovered four issues with the BrightView Family systems. Issue 1:...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: BrightView are gamma cameras Recalled by Philips Medical Systems (Cleveland)...

The Issue: The firm discovered four issues with the BrightView Family systems. Issue 1:...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2015· Stryker Sustainability Solutions

Recalled Item: Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Recalled...

The Issue: Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2015· Arthrex, Inc.

Recalled Item: Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC Recalled by...

The Issue: Devices reported to have a smooth texture to the outer surface of the metal,...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2015· Merge Healthcare, Inc.

Recalled Item: RadSuite Recalled by Merge Healthcare, Inc. Due to Potential incorrect...

The Issue: Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2015· Philips Medical Systems (Cleveland) Inc

Recalled Item: BrightView XCT & BrightView XCT Upgrade Recalled by Philips Medical Systems...

The Issue: The firm discovered four issues with the BrightView Family systems. Issue 1:...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 16, 2015· Maquet Datascope Corp - Cardiac Assist Division

Recalled Item: Cardiosave Hybrid and rescue IABP Recalled by Maquet Datascope Corp -...

The Issue: Maquet has recieved information that in some Cardiosave IABPS, the scroll...

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

Class II — Potential Health HazardOngoing