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 11261–11280 of 38,428 recalls
Recalled Item: Sorin Centrifugal Pump System
The Issue: One ferrite ring expected to be installed on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NobelReplace Conical Connection RP 4.3x11.5 mm STERILE R
The Issue: Due to 16 complaints related to drivers not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chameleon PTA Balloon Dilation Catheter 8 mm x 40 mm
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Digital Angiography System Bransist safire Generator Model D150GC-40
The Issue: Due to the inadequate adjusting criteria in installation,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Digital Angiography System Shimadzu Trinias Generator Model: D150GC-40
The Issue: Due to the inadequate adjusting criteria in installation,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger Fabius MRI Anesthesia Machine
The Issue: 26 Fabius MRI Anesthesia machines were distributed with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software 1898072 IPC upgrade v 2.7.3.0
The Issue: As a result of Medtronic's integrated power console
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20545 Vitale Silver calcium Alginate Dressings 4x5
The Issue: Firm discovered that an incorrect version of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20522 Vitale Silver calcium Alginate Dressings 2x2
The Issue: Firm discovered that an incorrect version of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20500 Vitale Silver calcium Alginate Dressing Ropes
The Issue: Firm discovered that an incorrect version of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20544 Vitale Silver calcium Alginate Dressings 4x4
The Issue: Firm discovered that an incorrect version of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 20548 Vitale Silver calcium Alginate Dressings 4x8
The Issue: Firm discovered that an incorrect version of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CURAD REUSABLE GEL HOT/COLD PACK
The Issue: The product contains natural rubber latex but the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acufex Access Advanced Positioning Kit - indicated for use to
The Issue: Products were shipped to the Global Distribution Center
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OXY-1 System
The Issue: The firm has received complaints of the OXY-1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DuraMatrix-Onlay Collagen Dura Substitute Membrane 4 inches x 5 inches
The Issue: Outer packaging (outer pouch) is not sealed compromising
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RESODURA matrix onlay 10.0 cm x 12.5 cm - indicated
The Issue: Outer packaging (outer pouch) is not sealed compromising
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OER-Elite Endoscope Reprocessor-for use in cleaning and high-level...
The Issue: The detergent and alcohol tank tubing may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The EnPlace is a single use trans-vaginal pelvic floor repair
The Issue: Certain lots may not have been packaged wth
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products VersaTips
The Issue: The lot has a shape deformity which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.