Product Recalls in Indiana

Product recalls affecting Indiana — including food, drugs, consumer products, medical devices, and vehicles distributed to Indiana. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,704 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,704 in last 12 months

Showing 1090110920 of 29,228 recalls

Medical DeviceNovember 6, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: Tina-quant C-Reactive Protein Gen.3 Recalled by Roche Diagnostics...

The Issue: Roche confirmed customer complaints of low quality (QC) recovery and invalid...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 6, 2020· Spacelabs Healthcare, Ltd.

Recalled Item: Sentinel V10.x & V11.x Recalled by Spacelabs Healthcare, Ltd. Due to During...

The Issue: During system upgrade incorrect comments may be added to existing tests. In...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 5, 2020· Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

Recalled Item: Cobalt Implantable Cardioverter Defibrillators with Cardiac...

The Issue: Manufacturing error that may have resulted in a cathode component being out...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 5, 2020· Medline Industries Inc

Recalled Item: RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch Recalled by...

The Issue: RevMedX Trauma Dressing is being recalled due to package seal integrity.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 5, 2020· VEO DIAGNOSTICS, LLC

Recalled Item: ACCEL ELISA COVID-19 for the detection of total antibodies to Recalled by...

The Issue: Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 4, 2020· K2M, Inc

Recalled Item: Everest MI XT Tab Removal Tool (i.e. All-In-One Tab Removal Recalled by K2M,...

The Issue: All-in-One Tab Removal Tool may cause cracking and/or separating at the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2020· NEOSTEO

Recalled Item: Cannulated graduated drill bit 1.9 mm diameter Recalled by NEOSTEO Due to...

The Issue: Traces of corrosion on the laser marking was detected on cannulated...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2020· GA HEALTH COMPANY LIMITED

Recalled Item: ScopeValet Guardian Disposable Endoscope Valves Set Distributed By Ruhof...

The Issue: Suction button is reported sticky and/or broken during or after the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2020· GA HEALTH COMPANY LIMITED

Recalled Item: Andorate Disposable Endoscope Valves Set-5-piece Valve Recalled by GA HEALTH...

The Issue: Suction button is reported sticky and/or broken during or after the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2020· GA HEALTH COMPANY LIMITED

Recalled Item: STOPCON Disposable Endoscope Valves Set-Single Use Valves Olympus R...

The Issue: Suction button is reported sticky and/or broken during or after the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2020· GA HEALTH COMPANY LIMITED

Recalled Item: Andorate Disposable Endoscope Valves Set-Contains Suction Recalled by GA...

The Issue: Suction button is reported sticky and/or broken during or after the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2020· GA HEALTH COMPANY LIMITED

Recalled Item: Andorate Disposable Endoscope Valves Set-Contains Air/Water Valve Recalled...

The Issue: Suction button is reported sticky and/or broken during or after the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2020· GA HEALTH COMPANY LIMITED

Recalled Item: Bulldog Disposable Endoscope Valves Set-Air/Water Valve Recalled by GA...

The Issue: Suction button is reported sticky and/or broken during or after the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2020· GA HEALTH COMPANY LIMITED

Recalled Item: Bulldog Disposable Endoscope Valves Set-Air/Water Valve Recalled by GA...

The Issue: Suction button is reported sticky and/or broken during or after the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2020· GA HEALTH COMPANY LIMITED

Recalled Item: ScopeValet Guardian Disposable Endoscope Valves Set- Air/Water Recalled by...

The Issue: Suction button is reported sticky and/or broken during or after the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2020· GA HEALTH COMPANY LIMITED

Recalled Item: STOPCON Disposable Valves Set-Single Use Single Use Valves Olympus R...

The Issue: Suction button is reported sticky and/or broken during or after the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2020· GA HEALTH COMPANY LIMITED

Recalled Item: STOPCON Suction Valve-Suction Valve for GI-Endoscope DISTRIBUTED BY: KEY...

The Issue: Suction button is reported sticky and/or broken during or after the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2020· GA HEALTH COMPANY LIMITED

Recalled Item: STOPCON Disposable Valves Set-Single Use Valves...

The Issue: Suction button is reported sticky and/or broken during or after the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2020· Kowa Optimed Inc

Recalled Item: Kowa VK-2s software Version 10.0.4.0 Recalled by Kowa Optimed Inc Due to It...

The Issue: It has been determined that the software distributed with the retinal camera...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 3, 2020· K2M, Inc

Recalled Item: Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Recalled...

The Issue: Shafts do not pass through the inner cannula of the Anti-Torque Alignment...

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

Class II — Potential Health HazardOngoing