Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 28821–28840 of 38,428 recalls
Recalled Item: Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US.
The Issue: Due to the potential for reporting erroneous results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿
The Issue: Due to the potential for reporting erroneous results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Factor VIII Chromogenic Assay
The Issue: Factor VIII Chromogenic Assay Lot 44637 is showing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW.
The Issue: Due to the potential for reporting erroneous results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific
The Issue: Boston Scientific is voluntarily recalling its Chariot" Guiding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest¿
The Issue: Due to the potential for reporting erroneous results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TCM CombiM Modules 903-111
The Issue: Radiometer America, Inc. is recalling TCM CombiM on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVION S250 Radiation therapy system
The Issue: The treatment table positioning belt can slip gear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator
The Issue: Certain Model 106 Pulse Generators demonstrate delays in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software version VD10E for Syngo X-Workplace
The Issue: post-processing software issue when using tabcard "4D"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dressol-X
The Issue: Rainbow Specialty & Health Products initiated a field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FB Broth
The Issue: The firm is recalling FB Broth Cat. no
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dressit-X
The Issue: Rainbow Specialty & Health Products initiated a field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
The Issue: One batch of osteosynthesis screws were manufactured with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge RadSuite software. The firm name on the label is Merge Healthcare
The Issue: The values provided from the Pixel Value tool
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG
The Issue: Lumenis Ltd Announces a Field Action of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZCORE Porcine Xenograft Particulate in Syringe Product Intended for use
The Issue: The distributor, Osteogenics Biomedical, notified the firm that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediChoice Cohesive Bandages
The Issue: MediChoice sterile cohesive bandages imported and sold under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediChoice Cohesive Bandages
The Issue: MediChoice sterile cohesive bandages imported and sold under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MediChoice Cohesive Bandages
The Issue: MediChoice sterile cohesive bandages imported and sold under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.