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. 2,634 recalls have been distributed to Kentucky in the last 12 months.

51,386 total recalls
2,634 in last 12 months

Showing 88018820 of 28,748 recalls

Medical DeviceNovember 22, 2021· Uromedica Inc.

Recalled Item: UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar) Recalled by...

The Issue: The U-channel sheaths may cause damage to ProACT implant devices when the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 22, 2021· Cardiovascular Systems Inc

Recalled Item: WIRION EMBOLIC PROTECTION SYSTEM Recalled by Cardiovascular Systems Inc Due...

The Issue: Under certain circumstances, the WIRION filter assembly may become difficult...

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 19, 2021· Ki Mobility Llc

Recalled Item: Ki Mobility Recalled by Ki Mobility Llc Due to The Instructions for Use...

The Issue: The Instructions for Use provided with the device contained information...

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

Class III — Low RiskOngoing
Medical DeviceNovember 19, 2021· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Edge Plus-Computed tomography system Model 1026700 Recalled by...

The Issue: Software version VB20_SP5 my lead to a relevant degradation of head image...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2021· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Definition AS-Computed tomography system Model 8098027 Recalled by...

The Issue: Software version VB20_SP5 my lead to a relevant degradation of head image...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2021· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Definition Edge -Computed tomography system Model 10590000 Recalled...

The Issue: Software version VB20_SP5 my lead to a relevant degradation of head image...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2021· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Confidence -Computed tomography systems Model 10590100 Recalled by...

The Issue: Software version VB20_SP5 my lead to a relevant degradation of head image...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2021· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Instructions for Use for all model numbers of the Medtronic Recalled by...

The Issue: There have been reports of stent migration.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2021· DiaSorin Molecular LLC

Recalled Item: Simplexa Direct Amplification Disc Kit Recalled by DiaSorin Molecular LLC...

The Issue: A subset of affected discs are at risk of leakage when it is used more than...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2021· Philips North America Llc

Recalled Item: Philips Allura Xper FD series with Software Version Number: 2.1.x- Recalled...

The Issue: Set screws securing the two gliding rods of the Extra Monitors (called 7th...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 18, 2021· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An...

The Issue: (1)Software (SW) versions V1.25.1 and lower may result in TDef (Test...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 17, 2021· Luminex Corporation

Recalled Item: ARIES HSV 1&2 Assay Recalled by Luminex Corporation Due to Impacted lot may...

The Issue: Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 17, 2021· Stanley Security Solutions Inc

Recalled Item: Senior Living Arial Emergency and Nurse Call Systems Recalled by Stanley...

The Issue: Systems are not alarming due to increased memory consumption.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 16, 2021· Roche Molecular Systems, Inc.

Recalled Item: cobas LiatSystem Recalled by Roche Molecular Systems, Inc. Due to Roche has...

The Issue: Roche has identified a small number of cobas Liat analyzer units that have...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 16, 2021· Ohio Medical Corporation

Recalled Item: Instavac Portable Suction Pump Recalled by Ohio Medical Corporation Due to...

The Issue: Increase in premature device failures

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 16, 2021· Abbott

Recalled Item: Ultimum HEMOSTASIS INTRODUCER 5f 1.67 MM Recalled by Abbott Due to As a...

The Issue: As a result of a manufacturing error, one (1) lot of Ultimum Hemostasis...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 15, 2021· Datascope Corp.

Recalled Item: Cardiosave Rescue IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-75...

The Issue: Firm is initiating a correction due to the possibility of fluid ingress....

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 15, 2021· Datascope Corp.

Recalled Item: Cardiosave Hybrid IntraAortic Balloon Pump. Model Numbers: 0998-00-0800-31...

The Issue: Firm is initiating a correction due to the possibility of fluid ingress....

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 12, 2021· Siemens Medical Solutions USA, Inc.

Recalled Item: ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B...

The Issue: Due to a calculation error in the measurement when using 2D trace (manual...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 12, 2021· Philips North America Llc

Recalled Item: Philips Azurion Interventional Fluoroscopic X-ray System with Azurion R2.2...

The Issue: (1)Start-up problem: Intermittently at start-up of the system, the...

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

Class II — Potential Health HazardOngoing