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. 2,752 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,752 in last 12 months

Showing 35813600 of 29,228 recalls

Medical DeviceJuly 9, 2024· Medtronic Perfusion Systems

Recalled Item: Medtronic DLP Single Stage Venous Cannulae with right angle metal tip...

The Issue: During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2024· Covidien

Recalled Item: Covideien McGRATH MAC Video Laryngoscope Recalled by Covidien Due to IFU...

The Issue: IFU update to address device's battery handling information.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2024· Covidien

Recalled Item: McGRATH" MAC EMS Video Laryngoscope Recalled by Covidien Due to Battery...

The Issue: Battery management system within Laryngoscope devices may deplete below the...

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

Class I — Serious Health HazardOngoing
Medical DeviceJuly 9, 2024· CareFusion 303, Inc.

Recalled Item: BD Pyxis QFill Replenishment Station Recalled by CareFusion 303, Inc. Due to...

The Issue: Due to software issue, there is a potential when a restock label is printed...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2024· DKK Dai-Ichi Shomei Co., Ltd.

Recalled Item: Aurora 3 Series Recalled by DKK Dai-Ichi Shomei Co., Ltd. Due to The weld on...

The Issue: The weld on the light head frame can crack which could lead to problems such...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2024· Covidien

Recalled Item: McGrath Mac Video Laryngoscope Recalled by Covidien Due to Battery...

The Issue: Battery management system within Laryngoscope devices may deplete below the...

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

Class I — Serious Health HazardOngoing
Medical DeviceJuly 9, 2024· DKK Dai-Ichi Shomei Co., Ltd.

Recalled Item: Aurora 2 Series Recalled by DKK Dai-Ichi Shomei Co., Ltd. Due to The weld on...

The Issue: The weld on the light head frame can crack which could lead to problems such...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 9, 2024· CareFusion 303, Inc.

Recalled Item: BKIT BD Pyxis QFill Replenishment Station Recalled by CareFusion 303, Inc....

The Issue: Due to software issue, there is a potential when a restock label is printed...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2024· Ion Beam Applications S.A.

Recalled Item: IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Recalled...

The Issue: Safety Parameters Verification Mechanisms can be deactivated in clinical runtime

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 8, 2024· NeuroLogica Corporation

Recalled Item: GM60A. Digital Diagnostic Mobile X-Ray System. Recalled by NeuroLogica...

The Issue: Potential for the anti-fall system of the device arm to fail.

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 5, 2024· DRG International, Inc.

Recalled Item: Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013...

The Issue: Invalid Controls. The Low Control is out of range; too high which causes...

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

Class III — Low RiskOngoing
Medical DeviceJuly 4, 2024· ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL

Recalled Item: FRT250 - 4.0-6.4 CARTRIDGE. Component of the Fassier-Duval Telescopic IM...

The Issue: During the assembly of the FRT250 cartridge assembly, an incorrect component...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 3, 2024· Siemens Medical Solutions USA, Inc

Recalled Item: Sensis Vibe systems with software version VD15B in combination with Recalled...

The Issue: If the Sensis documentation functionality is used during adding of...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 3, 2024· Ortho-Clinical Diagnostics, Inc.

Recalled Item: VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2 Recalled by...

The Issue: It was confirmed that fibrinogen in patient plasma samples precipitates out...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 3, 2024· Siemens Medical Solutions USA, Inc

Recalled Item: Sensis Vibe systems with software version VD15B-Intended to be used Recalled...

The Issue: If the Sensis documentation functionality is used during adding of...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 3, 2024· W.L. Gore & Associates, Inc.

Recalled Item: GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for...

The Issue: Devices were labeled with an expiration date of four years and ten days...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 3, 2024· Siemens Medical Solutions USA, Inc

Recalled Item: Sensis Vibe systems with software version VD15B in combination with Recalled...

The Issue: If the Sensis documentation functionality is used during adding of...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 3, 2024· Siemens Medical Solutions USA, Inc

Recalled Item: Sensis Vibe systems with software version VD15B in combination with Recalled...

The Issue: If the Sensis documentation functionality is used during adding of...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 2, 2024· Siemens Medical Solutions USA, Inc

Recalled Item: Luminos Agile Max -Intended to visualize anatomical structures by converting...

The Issue: The support arm may unintentionally lower resulting in injury to persons...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 2, 2024· Zimmer, Inc.

Recalled Item: CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Recalled by...

The Issue: Affected product has an increased risk of postoperative perisprosthetic...

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

Class II — Potential Health HazardOngoing