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. 2,697 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,697 in last 12 months

Showing 1218112200 of 29,228 recalls

Medical DeviceApril 6, 2020· Skeletal Kinetics, Llc

Recalled Item: OSTEOVATION EX Recalled by Skeletal Kinetics, Llc Due to Bone void filler...

The Issue: Bone void filler kits may not maintain its setting characteristics for the...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 3, 2020· Pega Medical Inc.

Recalled Item: Orthopedic manual Surgical Instrument handle for Simple Locking Intra...

The Issue: The lot number on the pediatric orthopedic implant driver instrument handle...

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

Class III — Low RiskOngoing
Medical DeviceApril 3, 2020· Skeletal Kinetics, Llc

Recalled Item: Cranio/Sculpt C Recalled by Skeletal Kinetics, Llc Due to Potential product...

The Issue: Potential product mix-up. The recalling firm has determined that one unit of...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 3, 2020· Philips North America, LLC

Recalled Item: Philips Azurion 7 M20 -XperGuide Software hosted in Interventional Workspot...

The Issue: When a user acquires XperCT scan on an Azurion 2.0 system, enters the...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 2, 2020· Osteomed, LLC

Recalled Item: OSTEOVATION 10 CC IMPACT FORMULA. REF/UDI: 390-2110/ /00813845021092 -...

The Issue: Incorrect shelf-life for bone void filler kits; the product may not maintain...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 2, 2020· Osteomed, LLC

Recalled Item: OSTEOVATION RMX Injectable BVF 5CC . REF/UDI: 390-6001/ /00813845021082 -...

The Issue: Incorrect shelf-life for bone void filler kits; the product may not maintain...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 2, 2020· Osteomed, LLC

Recalled Item: OSTEOVATIONEX 3CC IMPACTFORMULA. REF/UDI: 390-0203/00813845020030 - Product...

The Issue: Incorrect shelf-life for bone void filler kits; the product may not maintain...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 2, 2020· Osteomed, LLC

Recalled Item: OSTEOVATION RMX 10 CC Injectable. REF/UDI: 390-6002/ /00813845021099 -...

The Issue: Incorrect shelf-life for bone void filler kits; the product may not maintain...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 2, 2020· Osteomed, LLC

Recalled Item: OSTEOVATIONEX 5CC INJECT FORMULA. REF/UDI: 390-0005/00813845020023 - Product...

The Issue: Incorrect shelf-life for bone void filler kits; the product may not maintain...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 2, 2020· Osteomed, LLC

Recalled Item: OSTEOVATION 5CC IMPACTFORMULA. REF/UDI: 390-2105/00813845020085 - Product...

The Issue: Incorrect shelf-life for bone void filler kits; the product may not maintain...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 2, 2020· Osteomed, LLC

Recalled Item: OSTEOVATION 3CC IMPACTFORMULA. REF/UDI: 390-2103/00813845020078 - Product...

The Issue: Incorrect shelf-life for bone void filler kits; the product may not maintain...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 2, 2020· Osteomed, LLC

Recalled Item: OSTEOVATIONEX 2CC INJECT FORMULA. REF/UDI: 390-0002/00813845020009 - Product...

The Issue: Incorrect shelf-life for bone void filler kits; the product may not maintain...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 2, 2020· Osteomed, LLC

Recalled Item: OSTEOVATION 5CC INJECT FORMULA. REF/UDI: 390-2005/00813845020054 - Product...

The Issue: Incorrect shelf-life for bone void filler kits; the product may not maintain...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 2, 2020· Osteomed, LLC

Recalled Item: OSTEOVATIONEX 3CC INJECT FORMULA. REF/UDI: 390-0003/00813845020016 - Product...

The Issue: Incorrect shelf-life for bone void filler kits; the product may not maintain...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 2, 2020· Osteomed, LLC

Recalled Item: OSTEOVATIONEX 5CC IMPACTFORMULA. REF/UDI: 390-0205/00813845020047 - Product...

The Issue: Incorrect shelf-life for bone void filler kits; the product may not maintain...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 2, 2020· GE Healthcare, LLC

Recalled Item: Giraffe Shuttle. Upgrade Kits with part number 2109672-001 and 2109673-001...

The Issue: During Giraffe Shuttle charging, the batteries emit low concentrations of...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 2, 2020· Abbott Laboratories

Recalled Item: Accelerator APS Aliquoter Module Recalled by Abbott Laboratories Due to In...

The Issue: In the case of an AQM clot detection error a portion of the distilled water...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 2, 2020· Osteomed, LLC

Recalled Item: OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product...

The Issue: Incorrect shelf-life for bone void filler kits; the product may not maintain...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 1, 2020· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products CKMB Slides Recalled by Ortho-Clinical Diagnostics...

The Issue: The Spanish and Swedish language versions of the IFU state that the assay...

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

Class II — Potential Health HazardOngoing
Medical DeviceApril 1, 2020· Ortho-Clinical Diagnostics

Recalled Item: VITROS Chemistry Products CKMB Slides Recalled by Ortho-Clinical Diagnostics...

The Issue: The Spanish and Swedish language versions of the IFU state that the assay...

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

Class II — Potential Health HazardOngoing