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. 2,593 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,593 in last 12 months

Showing 1920119220 of 53,528 recalls

Medical DeviceJune 5, 2020· OrthoPediatrics Corp

Recalled Item: OrthoPediatrics ACL Reconstruction System ShieldLoc 6mm implant component...

The Issue: ShieldLoc implant component of the ACL Reconstruction Systemlots may be...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 5, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: ADVIA Chemistry Calibrator Recalled by Siemens Healthcare Diagnostics, Inc....

The Issue: Calibration errors have been observed with the Total and Direct Bilirubin...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 5, 2020· Siemens Healthcare Diagnostics, Inc.

Recalled Item: Atellica CH Chemistry Calibrator Recalled by Siemens Healthcare Diagnostics,...

The Issue: Calibration errors have been observed with the Total and Direct Bilirubin...

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

Class II — Potential Health HazardOngoing
DrugJune 4, 2020· SOMERSET THERAPEUTICS LLC

Recalled Item: Brimonidine Tartrate Opthalmic Solution 0.2% Recalled by SOMERSET...

The Issue: Failed Impurities/Degradation Specification: There is a slow leaching...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugJune 4, 2020· SOMERSET THERAPEUTICS LLC

Recalled Item: Brimonidine Tartrate Opthalmic Solution 0.2% Recalled by SOMERSET...

The Issue: Failed Impurities/Degradation Specification: There is a slow leaching...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugJune 4, 2020· SOMERSET THERAPEUTICS LLC

Recalled Item: Brimonidine Tartrate Opthalmic Solution 0.2% Recalled by SOMERSET...

The Issue: Failed Impurities/Degradation Specification: There is a slow leaching...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugJune 4, 2020· AVKARE Inc.

Recalled Item: Metformin Hydrochloride Extended-Release Tablets Recalled by AVKARE Inc. Due...

The Issue: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA)...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugJune 4, 2020· AVKARE Inc.

Recalled Item: Metformin Hydrochloride Extended-Release Tablets Recalled by AVKARE Inc. Due...

The Issue: CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA)...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
Medical DeviceJune 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology Recalled by Boston Scientific Corporation Due to...

The Issue: The needle surface deteriorated due to unexpected electrolysis during procedure.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology Recalled by Boston Scientific Corporation Due to...

The Issue: The needle surface deteriorated due to unexpected electrolysis during procedure.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology Recalled by Boston Scientific Corporation Due to...

The Issue: The needle surface deteriorated due to unexpected electrolysis during procedure.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology Recalled by Boston Scientific Corporation Due to...

The Issue: The needle surface deteriorated due to unexpected electrolysis during procedure.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology Recalled by Boston Scientific Corporation Due to...

The Issue: The needle surface deteriorated due to unexpected electrolysis during procedure.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology Recalled by Boston Scientific Corporation Due to...

The Issue: The needle surface deteriorated due to unexpected electrolysis during procedure.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology Recalled by Boston Scientific Corporation Due to...

The Issue: The needle surface deteriorated due to unexpected electrolysis during procedure.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology Recalled by Boston Scientific Corporation Due to...

The Issue: The needle surface deteriorated due to unexpected electrolysis during procedure.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology Recalled by Boston Scientific Corporation Due to...

The Issue: The needle surface deteriorated due to unexpected electrolysis during procedure.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 4, 2020· Boston Scientific Corporation

Recalled Item: Ablation Galil Technology Recalled by Boston Scientific Corporation Due to...

The Issue: The needle surface deteriorated due to unexpected electrolysis during procedure.

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 4, 2020· Cardinal Health 200, LLC

Recalled Item: Cardinal Health NPWT Canister with Gel 300cc Recalled by Cardinal Health...

The Issue: Canisters potentially contain an oversized O-ring that cannot be installed...

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

Class II — Potential Health HazardOngoing
Medical DeviceJune 4, 2020· Cardinal Health 200, LLC

Recalled Item: Cardinal Health NPWT Occlusion Detection Canister 300cc Recalled by Cardinal...

The Issue: Canisters potentially contain an oversized O-ring that cannot be installed...

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

Class II — Potential Health HazardOngoing