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. 2,723 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,723 in last 12 months

Showing 1060110620 of 29,228 recalls

Medical DeviceDecember 18, 2020· Alung Technologies Inc

Recalled Item: ALung Technologies Hemolung Respiratory Assist System (RAS) with CME...

The Issue: CME America BodyGuard 323 Infusion Pumps (recalled by manufacturer) is a...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2020· Laerdal Medical (Suzhou) Co., Ltd.

Recalled Item: Laerdal Compact Suction Unit (LCSU 4) Recalled by Laerdal Medical (Suzhou)...

The Issue: Component failures may cause the unit to lose all suction. Users will need...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 18, 2020· Ansh Labs, LLC

Recalled Item: AnshLabs - SARS-CoV2 IgM ELISA (u-Capture) Recalled by Ansh Labs, LLC Due to...

The Issue: Labeling update; To reduce the risk of false positive/false negative results...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2020· GE Healthcare, LLC

Recalled Item: System Recalled by GE Healthcare, LLC Due to GE Healthcare has become aware...

The Issue: GE Healthcare has become aware of a potential issue on Revolution Apex,...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2020· GE Healthcare, LLC

Recalled Item: System Recalled by GE Healthcare, LLC Due to GE Healthcare has become aware...

The Issue: GE Healthcare has become aware of a potential issue on Revolution Apex,...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2020· Fresenius Medical Care Holdings, Inc.

Recalled Item: Fresenius Medical Care NaturaLyte Liquid Acid concentrate-Liquid Acid...

The Issue: Bottles Missing Product Label

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2020· Roche Diagnostics Operations, Inc.

Recalled Item: A calculator/data processing module for clinical use is an electronic...

The Issue: A software error results in the unintentional removal of the serum-indices...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2020· Bioventus, LLC

Recalled Item: EXOGEN Ultrasound Coupling Gel Recalled by Bioventus, LLC Due to Product may...

The Issue: Product may contain white particulates that are microbial in nature.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 16, 2020· Microbiologics Inc

Recalled Item: KWIK-STI(TM) Recalled by Microbiologics Inc Due to The expiration date on...

The Issue: The expiration date on the label of one component (negative control 0243U)...

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

Class III — Low RiskOngoing
Medical DeviceDecember 16, 2020· Philips Ultrasound Inc

Recalled Item: Philips EPIQ Diagnostic Ultrasound System Recalled by Philips Ultrasound Inc...

The Issue: The manufacturer discovered an issue associated with the EPIQ Image Boost...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 16, 2020· Medtronic Neurosurgery

Recalled Item: X1 Recalled by Medtronic Neurosurgery Due to Neonatal Valves were...

The Issue: Neonatal Valves were manufactured with a ventricular catheter connection...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 16, 2020· Medtronic Neurosurgery

Recalled Item: X1 Recalled by Medtronic Neurosurgery Due to Neonatal Valves were...

The Issue: Neonatal Valves were manufactured with a ventricular catheter connection...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 16, 2020· Medtronic Neurosurgery

Recalled Item: X1 Recalled by Medtronic Neurosurgery Due to Neonatal Valves were...

The Issue: Neonatal Valves were manufactured with a ventricular catheter connection...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 16, 2020· Cook Medical Llc

Recalled Item: Disposable Humidification Flask Recalled by Cook Medical Llc Due to A small...

The Issue: A small percentage of the Disposable Humidification Flasks may have a...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 15, 2020· Wahl Clipper Corp

Recalled Item: WAHL 4212 HEATED MASSAGER Recalled by Wahl Clipper Corp Due to The...

The Issue: The connection between the massager and heat element can overheat causing...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 15, 2020· Penumbra Inc.

Recalled Item: Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing...

The Issue: The catheter may become susceptible to distal tip damage during use. Distal...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 15, 2020· Penumbra Inc.

Recalled Item: Penumbra JET 7 Reperfusion Catheter The Penumbra JET Recalled by Penumbra...

The Issue: The catheter may become susceptible to distal tip damage during use. Distal...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 15, 2020· Penumbra Inc.

Recalled Item: Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Recalled by...

The Issue: The catheter may become susceptible to distal tip damage during use. Distal...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 15, 2020· Boston Scientific Corporation

Recalled Item: ACUITY Universal Cutter Recalled by Boston Scientific Corporation Due to...

The Issue: Boston Scientific (BSC) is retrieving five Model 7060 ACUITY cutters...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 15, 2020· Penumbra Inc.

Recalled Item: Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing...

The Issue: The catheter may become susceptible to distal tip damage during use. Distal...

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

Class I — Serious Health HazardOngoing