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. 2,630 recalls have been distributed to Kentucky in the last 12 months.

51,386 total recalls
2,630 in last 12 months

Showing 97419760 of 28,748 recalls

Medical DeviceApril 28, 2021· Medtronic Vascular, Inc.

Recalled Item: Endurant II/IIs Stent Graft System: STENT GRAFT ETBF3216C145E ENDUR II...

The Issue: Incorrect stentstop assembly (18fr) was used to build the delivery system...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 27, 2021· Quidel Corporation

Recalled Item: Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagent Recalled by...

The Issue: In rare situations patients infected with high viral load of SARS CoV 2 may...

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

Class I — Serious Health HazardOngoing
Medical DeviceApril 27, 2021· Circulatory Technology Inc.

Recalled Item: The Better-Bladder (BB) Recalled by Circulatory Technology Inc. Due to The...

The Issue: The device is used as part of extracorporeal membrane oxygenation (ECMO)...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 27, 2021· Quanta System, S.p.A.

Recalled Item: Quanta System Sterile Optical Laser Fiber Recalled by Quanta System, S.p.A....

The Issue: Product sterility is potentially compromised.

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 27, 2021· Quanta System, S.p.A.

Recalled Item: Olympus Sterile Optical Laser Fiber Recalled by Quanta System, S.p.A. Due to...

The Issue: Product sterility is potentially compromised.

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 27, 2021· Quanta System, S.p.A.

Recalled Item: Quanta System Sterile Optical Laser Fiber Recalled by Quanta System, S.p.A....

The Issue: Product sterility is potentially compromised.

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 26, 2021· Xstrahl Limited

Recalled Item: Concerto User Interface Software provided with the following systems: (1)...

The Issue: If a saved treatment plan with 2 opposing beams is edited prior to approval,...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 26, 2021· Northeast Scientific Inc.

Recalled Item: NES Reprocessed Visions PV .035 IVUS Catheter Recalled by Northeast...

The Issue: 510k indicated one (1) reprocessing cycle, product not cleared for...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System Recalled by Alphatec Spine,...

The Issue: There is a potential for the screw blocking mechanism on the anterior...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System Recalled by Alphatec Spine,...

The Issue: There is a potential for the screw blocking mechanism on the anterior...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System Recalled by Alphatec Spine,...

The Issue: There is a potential for the screw blocking mechanism on the anterior...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System Recalled by Alphatec Spine,...

The Issue: There is a potential for the screw blocking mechanism on the anterior...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System Recalled by Alphatec Spine,...

The Issue: There is a potential for the screw blocking mechanism on the anterior...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System Recalled by Alphatec Spine,...

The Issue: There is a potential for the screw blocking mechanism on the anterior...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System Recalled by Alphatec Spine,...

The Issue: There is a potential for the screw blocking mechanism on the anterior...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System Recalled by Alphatec Spine,...

The Issue: There is a potential for the screw blocking mechanism on the anterior...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System Recalled by Alphatec Spine,...

The Issue: There is a potential for the screw blocking mechanism on the anterior...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System Recalled by Alphatec Spine,...

The Issue: There is a potential for the screw blocking mechanism on the anterior...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System Recalled by Alphatec Spine,...

The Issue: There is a potential for the screw blocking mechanism on the anterior...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 26, 2021· Alphatec Spine, Inc.

Recalled Item: Atec Insignia Anterior Cervical Plate System Recalled by Alphatec Spine,...

The Issue: There is a potential for the screw blocking mechanism on the anterior...

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

Class II — Potential Health HazardOngoing