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 88418860 of 29,228 recalls

Medical DeviceNovember 29, 2021· Ion Beam Applications S.A.

Recalled Item: Proteus 235 Recalled by Ion Beam Applications S.A. Due to Proton Therapy...

The Issue: Proton Therapy System (PTS) software can be started in the clinical...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 26, 2021· Philips North America Llc

Recalled Item: Infa-Therm Transport Mattress Recalled by Philips North America Llc Due to...

The Issue: After the device was cleared by the FDA, Philips made changes to the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 24, 2021· Philips North America Llc

Recalled Item: Philips Allura Xper Recalled by Philips North America Llc Due to Due to a...

The Issue: Due to a leak in the detector cooling system, cooling liquid may leak...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 24, 2021· Philips North America Llc

Recalled Item: Philips Allura CV20 Interventional Fluoroscopic X-ray System products with a...

The Issue: Due to a leak in the detector cooling system, cooling liquid may leak...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 24, 2021· Reflexion Medical, Inc.

Recalled Item: Medical Radiotherapy System - System Label: "*** by Medical, Inc. Due to Due...

The Issue: Due to dose discrepancy when delivering a plan to a patient in a Non-HFS...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 24, 2021· Nikkiso Ltd - Shizuoka Plant

Recalled Item: DBB-06 Hemodialysis Delivery System Recalled by Nikkiso Ltd - Shizuoka Plant...

The Issue: Device lacks premarket approval.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 24, 2021· Howmedica Osteonics Corp.

Recalled Item: Triathlon Pro Tibial Preparation Tray Recalled by Howmedica Osteonics Corp....

The Issue: Triathlon Pro Tibial Preparation Tray may have been kitted with the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 23, 2021· Siemens Medical Solutions USA, Inc

Recalled Item: 1. Sensis Recalled by Siemens Medical Solutions USA, Inc Due to Software...

The Issue: Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo...

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

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

Recalled Item: BALLARD* Multi-Access Port Catheter Recalled by Avanos Medical, Inc. Due to...

The Issue: Product was distributed with incorrect expiration date.

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

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

Recalled Item: BALLARD* Multi-Access Port (MAP) Catheter Recalled by Avanos Medical, Inc....

The Issue: Product was distributed with incorrect expiration date.

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

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

Recalled Item: BALLARD* Seal Cassette Replacement MAP - BALLARD* Seal Cassette Replacement...

The Issue: Product was distributed with incorrect expiration date.

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 22, 2021· Ortho-Clinical Diagnostics, Inc.

Recalled Item: VITROS Immunodiagnostic Products High Sample Diluent A Reagent Pack Recalled...

The Issue: Lower than expected results for VITROS¿ Immunodiagnostic Products TSH...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 22, 2021· Gentherm Medical, LLC

Recalled Item: Electri-Cool II Portable Cold Therapy Unit Recalled by Gentherm Medical, LLC...

The Issue: This recall has been initiated to provide a labeling update with revised...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 22, 2021· Uromedica Inc.

Recalled Item: UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar) Recalled by...

The Issue: The U-channel sheaths may cause damage to ProACT implant devices when the...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 22, 2021· Cardiovascular Systems Inc

Recalled Item: WIRION EMBOLIC PROTECTION SYSTEM Recalled by Cardiovascular Systems Inc Due...

The Issue: Under certain circumstances, the WIRION filter assembly may become difficult...

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

Class I — Serious Health HazardOngoing
Medical DeviceNovember 19, 2021· Medtronic Sofamor Danek USA Inc

Recalled Item: Distractor Rack Recalled by Medtronic Sofamor Danek USA Inc Due to Two lots...

The Issue: Two lots of the 5598007 Distractor Rack which were not manufactured to...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2021· Ki Mobility Llc

Recalled Item: Ki Mobility Recalled by Ki Mobility Llc Due to The Instructions for Use...

The Issue: The Instructions for Use provided with the device contained information...

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

Class III — Low RiskOngoing
Medical DeviceNovember 19, 2021· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Edge Plus-Computed tomography system Model 1026700 Recalled by...

The Issue: Software version VB20_SP5 my lead to a relevant degradation of head image...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2021· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Definition AS-Computed tomography system Model 8098027 Recalled by...

The Issue: Software version VB20_SP5 my lead to a relevant degradation of head image...

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

Class II — Potential Health HazardOngoing
Medical DeviceNovember 19, 2021· Siemens Medical Solutions USA, Inc

Recalled Item: SOMATOM Definition Edge -Computed tomography system Model 10590000 Recalled...

The Issue: Software version VB20_SP5 my lead to a relevant degradation of head image...

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

Class II — Potential Health HazardOngoing