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 29781–29800 of 38,428 recalls
Recalled Item: Slip-Cath Beacon Tip Catheter. Angiographic catheter. For use in angiographic
The Issue: Reports of catheter tip splits and or separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beacon Tip Torcon NB Advantage Catheter. Angiographic catheter. For use
The Issue: Reports of catheter tip splits and or separation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Silhouette Lift brochure Silhouette Sutures are for use in midface
The Issue: Silhouette Lift is recalling the Silhouette Suture brochure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Tibial Nail Wrap Holds 11 Nails and Synthes Intramedullary
The Issue: The wrap is for single use for nail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8.5mm Reamer Head for Flexible Intramedullary Nailing System
The Issue: The possibility exists for intraoperative reamer head breakages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Battery Power Line II Oscillator Model 530.710
The Issue: Saw head separated from the drive unit or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT
The Issue: Philips has identified four (4) software defects in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT
The Issue: Philips has identified four (4) software defects in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT
The Issue: Philips has identified four (4) software defects in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iovera 155 Smart Tip
The Issue: The expiration date on the outer box label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT
The Issue: Philips has identified four (4) software defects in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging
The Issue: Philips has identified four (4) software defects in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems
The Issue: Philips has identified four (4) software defects in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging
The Issue: Philips has identified four (4) software defects in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ Oncology Information System MOSAIQ is an oncology information system
The Issue: A problem exists in MOSAIQ resulting in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America
The Issue: The firm discovered that the centrifugal force applied
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fujifilm Processor EPX 2500 High Definition Endoscopy
The Issue: The EPX-2500 Operation Manual and sales brochure incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fujinon/Fujifilm Processor EPX 2500 Operation Manual. For use in endoscopic
The Issue: The EPX-2500 Operation Manual and sales brochure incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT
The Issue: The suction button on the ED-530XT endoscope may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5
The Issue: Software anomaly may occur during the installation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.