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. 1,909 recalls have been distributed to Indiana in the last 12 months.

53,528 total recalls
1,909 in last 12 months

Showing 2808128100 of 29,228 recalls

Medical DeviceSeptember 14, 2012· Hologic, Inc.

Recalled Item: Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version...

The Issue: Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 14, 2012· Horiba Instruments, Inc dba Horiba Medical

Recalled Item: Minotrol 16 Recalled by Horiba Instruments, Inc dba Horiba Medical Due to...

The Issue: HORIBA Medical Irvine Technical Support received reports from some customers...

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

Class III — Low RiskOngoing
Medical DeviceSeptember 14, 2012· Advandx Inc

Recalled Item: AdvanDx E. coli/P. aeruginosa PNA FISH Recalled by Advandx Inc Due to...

The Issue: Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2012· OrthoPediatrics Corp

Recalled Item: Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary...

The Issue: A complaint received from sales representative that a replenishment...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2012· 3M Company - Health Care Business

Recalled Item: 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac...

The Issue: 3M determined that the electrical grounding mechanism for the Steri-Vac 5XL...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2012· Zimmer, Inc.

Recalled Item: CPT Modular Stem Recalled by Zimmer, Inc. Due to Zimmer Inc. is initiating a...

The Issue: Zimmer Inc. is initiating a removal of the CPT Modular Stem (item...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2012· Zimmer, Inc.

Recalled Item: CPT Femoral Stem 12/14 Neck Taper Extended Offset Recalled by Zimmer, Inc....

The Issue: Zimmer Inc. is initiating a removal of the CPT Modular Stem (item...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2012· Zimmer, Inc.

Recalled Item: CPT Hip System Femoral Stem Petite Recalled by Zimmer, Inc. Due to Zimmer...

The Issue: Zimmer Inc. is initiating a removal of the CPT Modular Stem (item...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 13, 2012· Heartsine Technologies, Limited

Recalled Item: HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501...

The Issue: Certain Samaritan 300/300P PAD devices may experience one or both of the...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 12, 2012· Siemens Medical Solutions USA, Inc

Recalled Item: Siemens Magnetom Skyra Recalled by Siemens Medical Solutions USA, Inc Due to...

The Issue: When positioning the Flex Large 4 Coil (part No. 8625761) off-center in...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2012· Philips Healthcare Inc.

Recalled Item: Philips Digital Diagnost with patient carriage Model: 712050 with serial...

The Issue: Hook does not securely hold the footplate in vertical position, causing the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 12, 2012· Mako Surgical Corporation

Recalled Item: The RIO (TGS 2.) Recalled by Mako Surgical Corporation Due to MAKO Surgical...

The Issue: MAKO Surgical Group recalled their RIO System software, version 2.4 and is...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 11, 2012· Philips Medical Systems (Cleveland) Inc

Recalled Item: Computed Tomography X-Ray System Brilliance Workspace Portal Recalled by...

The Issue: Philips was notified that when performing post processing with the...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 11, 2012· Siemens Healthcare Diagnostics, Inc

Recalled Item: Siemens ADVIA Centaur BR Assay: Catalog Number: US: Recalled by Siemens...

The Issue: BR Assay for CA 27.29 Calibration Interval Change due quality control (QC)...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 11, 2012· Philips Healthcare Inc.

Recalled Item: Philips HeartStart XL M4735A Defibrillator/Monitors Recalled by Philips...

The Issue: HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 10, 2012· Invacare Corporation

Recalled Item: Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility...

The Issue: The potential exists for the wheel to rotate freely despite engagement of...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 10, 2012· Terumo Cardiovascular Systems Corporation

Recalled Item: Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: Recalled...

The Issue: Terumo Cardiovascular Systems (CVS) received two reports of the false back...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2012· Baxter Healthcare Corp.

Recalled Item: Baxter Interlink System Buretrol Solution Set with 150 mL Burette Recalled...

The Issue: Baxter has determined that the ball-valve feature of the Buretrol Solution...

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

Class I — Serious Health HazardOngoing
Medical DeviceSeptember 7, 2012· Optovue Inc.

Recalled Item: materials "RETINAL OCT Analysis and Interpretation Method" shipped with...

The Issue: Devices labeled for an intended use not included in the existing 510(k) or...

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

Class II — Potential Health HazardOngoing
Medical DeviceSeptember 7, 2012· Baxter Healthcare Corp.

Recalled Item: Baxter Clearlink System Buretrol Solution Set Recalled by Baxter Healthcare...

The Issue: Baxter has determined that the ball-valve feature of the Buretrol Solution...

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

Class I — Serious Health HazardOngoing