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. 2,058 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,058 in last 12 months

Showing 98019820 of 29,228 recalls

Medical DeviceApril 29, 2021· Medtronic Perfusion Systems

Recalled Item: Medtronic CB10W64R1 Recalled by Medtronic Perfusion Systems Due to Specific...

The Issue: Specific lots may have been manufactured with insufficient or incomplete welds.

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 29, 2021· Covidien, LP

Recalled Item: Adult-Pediatric Electrostatic Filter HME Recalled by Covidien, LP Due to The...

The Issue: The company was notified by their supplier of sterilization services for...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 29, 2021· Medtronic Perfusion Systems

Recalled Item: Medtronic CB10Y89R10 Recalled by Medtronic Perfusion Systems Due to Specific...

The Issue: Specific lots may have been manufactured with insufficient or incomplete welds.

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 29, 2021· Medtronic Perfusion Systems

Recalled Item: Medtronic HY10L28R3 Recalled by Medtronic Perfusion Systems Due to Specific...

The Issue: Specific lots may have been manufactured with insufficient or incomplete welds.

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 29, 2021· Covidien, LP

Recalled Item: Mechanical Filter with Connector Small Recalled by Covidien, LP Due to The...

The Issue: The company was notified by their supplier of sterilization services for...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 29, 2021· Covidien, LP

Recalled Item: Electrostatic Filter Angled Recalled by Covidien, LP Due to The company was...

The Issue: The company was notified by their supplier of sterilization services for...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 28, 2021· Randox Laboratories Ltd.

Recalled Item: Randox RX Imola Analyser with ISE Recalled by Randox Laboratories Ltd. Due...

The Issue: An issue was identified where the software froze during processing of...

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

Class II — Potential Health HazardOngoing
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· 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 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· 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· 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· 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· Roche Diagnostics Operations, Inc.

Recalled Item: IRON GEN 2: ROCHE COBAS INTEGRA ANALYZER Recalled by Roche Diagnostics...

The Issue: Roche received several complaints regarding increased control recovery and...

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· 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· 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