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 30641–30660 of 38,428 recalls
Recalled Item: ANSPACH - 5MM x 11.3MM Fluted Barrel
The Issue: G1 Dissection Tools are not compatible with all
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH - 5MM Fluted Ball
The Issue: G1 Dissection Tools are not compatible with all
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANSPACH - Fluted Drum
The Issue: G1 Dissection Tools are not compatible with all
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Medi-Pak Vaginal Speculum
The Issue: Small sized specula were incorrectly packaged in printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT Computed Tomography X-ray system
The Issue: A calibrated torque wrench malfunctioned at the supplier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Keo Brace
The Issue: The product does not bear the caution label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS Ysio Max
The Issue: Study and all acquired images deleted when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elastic Ankle Support. A limb orthosis (brace) is a device
The Issue: The product does not bear the caution label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elastic Knee Support. A limb orthosis (brace) is a device
The Issue: The product does not bear the caution label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS Luminos Agile Max
The Issue: Study and all acquired images deleted when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS Axiom Luminos dRF Max
The Issue: Study and all acquired images deleted when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS Uroskop Omnia Max
The Issue: Study and all acquired images deleted when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COULTER DxH Diluent
The Issue: Beckman Coulter has received an increased number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic SynchroMed II Implantable Infusion Pumps
The Issue: Medtronic is conducting a recall of a specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIQ 7 Ultrasound System with Pediatric Cardiology option
The Issue: When Epiq 7 Ultrasound System, WITH the Pediatric
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIQ 5 Ultrasound System with Pediatric Cardiology option
The Issue: When Epiq 5 Ultrasound System, WITH the Pediatric
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4.0mm Variable Angle
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Female Driver
The Issue: The hexagonal tip of the Female Driver instrument
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge RadSuite software. Radiological image processing system.
The Issue: When RadSuite is used with IPID (Issuer of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Primus (THE BTE WS30)
The Issue: On the Primus that includes the optional Chop
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.