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 9061–9080 of 38,428 recalls
Recalled Item: MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter
The Issue: There is a potential leaking condition within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6.5 cm Pediatric Craniotome Attachment. Use with XMax¿
The Issue: Ball bearings in the CRANI-A (ANSPACH Power Tools
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7.5 cm Large Craniotome Attachment Use with XMax¿
The Issue: Ball bearings in the CRANI-A (ANSPACH Power Tools
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Trilogy 200 Ventilator
The Issue: The replacement silicone sound abatement foam installed into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿
The Issue: Ball bearings in the CRANI-A (ANSPACH Power Tools
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6.5 cm Adult Craniotome
The Issue: Ball bearings in the CRANI-A (ANSPACH Power Tools
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿
The Issue: Ball bearings in the CRANI-A (ANSPACH Power Tools
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adult Craniotome Intended for cutting and shaping bone
The Issue: Ball bearings in the CRANI-A (ANSPACH Power Tools
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with
The Issue: for Functional Sensitivity to not meet Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Garbin Ventilator
The Issue: The replacement silicone sound abatement foam installed into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis
The Issue: Device was shipped without having regulatory approval
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH)...
The Issue: Due to an issue of high coefficient of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Option Stemmed Tibial Component Size 7
The Issue: Zimmer Biomet is conducting a voluntary medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Option Stemmed Tibial Component Size 5
The Issue: Zimmer Biomet is conducting a voluntary medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Option Stemmed Tibial Component Size 4
The Issue: Zimmer Biomet is conducting a voluntary medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Option Stemmed Tibial Component Size 6
The Issue: Zimmer Biomet is conducting a voluntary medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Option Stemmed Tibial Component Size 8
The Issue: Zimmer Biomet is conducting a voluntary medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen Option Stemmed Tibial Component Size 3
The Issue: Zimmer Biomet is conducting a voluntary medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Turbett Surgical Container
The Issue: Pod may have weld failures breaching the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Turbett Surgical Container
The Issue: Pod may have weld failures breaching the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.