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. 2,729 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,729 in last 12 months

Showing 87618780 of 29,228 recalls

Medical DeviceDecember 22, 2021· Boston Scientific Corporation

Recalled Item: JAGTOME RX 39-20-260-025 Material Number: M00573080 Recalled by Boston...

The Issue: Sterility of device is compromised due to a sterile barrier breach

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2021· Boston Scientific Corporation

Recalled Item: JAGTOME REVOLUTION RX 39-20-450-025 Material Number: M00584250 Recalled by...

The Issue: Sterility of device is compromised due to a sterile barrier breach

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2021· Boston Scientific Corporation

Recalled Item: DREAMTOME 49-20MM/450CM Material Number: M00584020 Recalled by Boston...

The Issue: Sterility of device is compromised due to a sterile barrier breach

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2021· Boston Scientific Corporation

Recalled Item: Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material...

The Issue: Sterility of device is compromised due to a sterile barrier breach

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2021· Boston Scientific Corporation

Recalled Item: JAGTOME RX 49-30-450-035 Material Number: M00573030 Recalled by Boston...

The Issue: Sterility of device is compromised due to a sterile barrier breach

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2021· Boston Scientific Corporation

Recalled Item: JAGTOME RX 49-30-260-035 Material Number: M00573020 Recalled by Boston...

The Issue: Sterility of device is compromised due to a sterile barrier breach

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2021· Boston Scientific Corporation

Recalled Item: HYDRATOME RX 44-30MM/260CM Material Number: M00583050 Recalled by Boston...

The Issue: Sterility of device is compromised due to a sterile barrier breach

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2021· Medtronic Xomed, Inc.

Recalled Item: NIM TRIVANTAGE EMG Endotracheal Tube Recalled by Medtronic Xomed, Inc. Due...

The Issue: There is potential for multiple issues due to a manufacturing nonconformity.

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2021· Avanos Medical, Inc.

Recalled Item: MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors -...

The Issue: The External Retention Bolster contained in the kit may be a larger diameter...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2021· Synthes (USA) Products LLC

Recalled Item: Universal Chuck-The Universal Chuck is an Instrument Handle provided as...

The Issue: Top cap may loosen and detach if the Universal Chuck becomes jammed and the...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2021· Avanos Medical, Inc.

Recalled Item: MIC* Percutaneous Endoscopic Gastrostomy PEG Kit - 20 Fr-PULL Recalled by...

The Issue: The External Retention Bolster contained in the kit may be a larger diameter...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 22, 2021· Empowered Diagnostics LLC

Recalled Item: ImmunoPass Recalled by Empowered Diagnostics LLC Due to COVID test kits were...

The Issue: COVID test kits were offered for sale and distributed to consumers in the...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 22, 2021· Empowered Diagnostics LLC

Recalled Item: CovClear COVID-19 Rapid Antigen Test Recalled by Empowered Diagnostics LLC...

The Issue: COVID test kits were offered for sale and distributed to consumers in the...

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 21, 2021· Medtronic Vascular, Inc.

Recalled Item: Endurant Recalled by Medtronic Vascular, Inc. Due to Stent Graft Systems...

The Issue: Stent Graft Systems built with specific batches of taper tip assemblies have...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 20, 2021· Vyaire Medical

Recalled Item: bellavista 1000 ventilator Recalled by Vyaire Medical Due to Potential...

The Issue: Potential cessation in ventilation can occur under specific conditions.

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

Class I — Serious Health HazardOngoing
Medical DeviceDecember 20, 2021· Canon Medical System, USA, INC.

Recalled Item: Flat Panel Detector Recalled by Canon Medical System, USA, INC. Due to...

The Issue: Abnormal images such as horizontal stripes may be displayed and recovery may...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2021· Nobel Biocare Usa Llc

Recalled Item: NobelReplace Conical Connection RP 4.3x11.5 mm STERILE R Recalled by Nobel...

The Issue: Due to 16 complaints related to drivers not engaging in implants. According...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 17, 2021· Covidien Llc

Recalled Item: Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm Recalled by Covidien...

The Issue: The firm has received six (6) complaint reports from customers indicating...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 16, 2021· Shimadzu Medical Systems

Recalled Item: Digital Angiography System Bransist safire Generator Model D150GC-40...

The Issue: Due to the inadequate adjusting criteria in installation, the system...

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

Class II — Potential Health HazardOngoing
Medical DeviceDecember 16, 2021· Shimadzu Medical Systems

Recalled Item: Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40...

The Issue: Due to the inadequate adjusting criteria in installation, the system...

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

Class II — Potential Health HazardOngoing