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. 2,520 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
2,520 in last 12 months

Showing 3464134660 of 53,528 recalls

Medical DeviceJuly 21, 2016· Smith & Nephew, Inc.

Recalled Item: RENASYS Sterile Transparent Film and all the RENASYS Dressing kits Recalled...

The Issue: Sterility seal integrity failures on the Renasys Sterile Transparent Film

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 21, 2016· Integra LifeSciences Corp.

Recalled Item: Large QWIX Compression screw Recalled by Integra LifeSciences Corp. Due to...

The Issue: Labeling on the Qwix Screw product states that it is a "compression screw"...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Zimmer Biomet, Inc.

Recalled Item: ROSA Brain 3.0.0 Usage: The device is intended for the Recalled by Zimmer...

The Issue: Communication errors between ROSANNA BRAIN software, MARIO software and the...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Cardinal Health

Recalled Item: BLUE IMPERVIOUS GOWN WITH THUMBHOOKS Recalled by Cardinal Health Due to Blue...

The Issue: Blue Impervious Gown with thumbhooks, X-large. All lots do not meet design...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance CT 16 Power Recalled by Philips Medical Systems (Cleveland) Inc...

The Issue: After upgrading to 3.6.7 software version via FCO72800643, during...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance 64 CT Model number 728231 Product Usage: Computed Tomography...

The Issue: After upgrading to 3.6.7 software version via FCO72800643, during...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance CT Big Bore Oncology Recalled by Philips Medical Systems...

The Issue: After upgrading to 3.6.7 software version via FCO72800643, during...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance BigBore Radiology CT Model number 728244 Product Usage: Computed...

The Issue: After upgrading to 3.6.7 software version via FCO72800643, during...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: Brilliance 16 Recalled by Philips Medical Systems (Cleveland) Inc Due to...

The Issue: After upgrading to 3.6.7 software version via FCO72800643, during...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity Core Recalled by Philips Medical Systems (Cleveland) Inc Due to...

The Issue: After upgrading to 3.6.7 software version via FCO72800643, during...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Philips Medical Systems (Cleveland) Inc

Recalled Item: Ingenuity Core128 Recalled by Philips Medical Systems (Cleveland) Inc Due to...

The Issue: After upgrading to 3.6.7 software version via FCO72800643, during...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Integra LifeSciences Corp.

Recalled Item: Integra External Fixation System Universal Wire Fixation Bolt - 17.5...

The Issue: Through the investigation of reported complaints Integra verified that there...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Integra LifeSciences Corp.

Recalled Item: Integra External Fixation System Slotted Post - Small Catalogue #12224228...

The Issue: Through the investigation of reported complaints Integra verified that there...

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

Class II — Potential Health HazardOngoing
Medical DeviceJuly 20, 2016· Nobel Biocare Usa Llc

Recalled Item: Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Recalled by...

The Issue: Incorrect drill protocol in the Instructions for Use (IFU)

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

Class II — Potential Health HazardOngoing
DrugJuly 19, 2016· Talon Compounding Pharmacy

Recalled Item: Human Chorionic Gonadotropin Injection (a) 2500 iu Recalled by Talon...

The Issue: Lack of Assurance of Sterility

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

Class II — Potential Health HazardOngoing
Refund
DrugJuly 19, 2016· Talon Compounding Pharmacy

Recalled Item: Sermorelin 6 mg and Sermorelin 6 mg/GHRP-2 Injection Recalled by Talon...

The Issue: Lack of Assurance of Sterility

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

Class II — Potential Health HazardOngoing
Refund
DrugJuly 19, 2016· Zydus Pharmaceuticals USA Inc

Recalled Item: Venlafaxine HCL ER Capsule USP Recalled by Zydus Pharmaceuticals USA Inc Due...

The Issue: Failed Dissolution Specifications: out of specification dissolution results...

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

Class II — Potential Health HazardOngoing
Refund
DrugJuly 19, 2016· Zydus Pharmaceuticals USA Inc

Recalled Item: Venlafaxine HCL ER Capsule USP Recalled by Zydus Pharmaceuticals USA Inc Due...

The Issue: Failed Dissolution Specifications: out of specification dissolution results...

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

Class II — Potential Health HazardOngoing
Refund
FoodJuly 19, 2016· Agave Dream

Recalled Item: Agave Dream Cappuccino Ice Cream Pint code: 899349002048 Recalled by Agave...

The Issue: Potential Listeria monocytogenes contamination.

Recommended Action: Do not consume. Return to store for a refund or discard.

Class I — Serious Health HazardOngoing
Refund
Medical DeviceJuly 19, 2016· Smith & Nephew, Inc.

Recalled Item: Smith & Nephew Whipknot Soft Tissue Cinch (USP#5) suture. PN: Recalled by...

The Issue: Sterility compromised due to breach in sterile packaging

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

Class II — Potential Health HazardOngoing