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 6321–6340 of 38,428 recalls
Recalled Item: GE Healthcare Care Plus Hood Field Replacement Unit (FRU) kit
The Issue: GE HealthCare has become aware that the bedside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Lullaby Incubator Model Hood FRU kit
The Issue: GE HealthCare has become aware that the bedside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare neonatal incubator
The Issue: GE HealthCare has become aware that the bedside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Senographe Pristina
The Issue: X-ray exposure termination audible signal on Senographe Pristina
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Power Knee
The Issue: Knee batteries may need replacement with conforming batteries
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEOS COLLAR STEM
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEOS COLLAR STEM
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aligned Medical Solutions
The Issue: Sterility assurance for saline included in surgical kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aligned Medical Solutions
The Issue: Sterility assurance for saline included in surgical kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aligned Medical Solutions
The Issue: Sterility assurance for saline included in surgical kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aligned Medical Solutions
The Issue: Sterility assurance for saline included in surgical kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Exactamix Pro 1200
The Issue: An error was identified in software versions 2.0.8
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Exactamix Pro 2400
The Issue: An error was identified in software versions 2.0.8
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled)
The Issue: Filling process qualification did not demonstrate adequate process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AFT (Allograft Filler Tube) Straight Tube (1/2 Filled)
The Issue: Filling process qualification did not demonstrate adequate process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use
The Issue: Failed to meet the acceptance criteria for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use
The Issue: Failed to meet the acceptance criteria for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Voluson IC9-RS intracavitary probes
The Issue: GE HealthCare has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rebstock Holding rod for fixation -For holding and fixation of
The Issue: Holding arm could move (twist) uncontrollably in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phantom TTC Nail
The Issue: Medical devices distributed, prior to sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.