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 38261–38280 of 38,428 recalls
Recalled Item: Xoran Mini CT Scanner
The Issue: A description of the defect in the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark
The Issue: The placement guidewire diameter is too large and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC
The Issue: The placement guidewire diameter is too large and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75"
The Issue: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle 4.0"
The Issue: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with
The Issue: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with
The Issue: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is labeled in part: "***MEDLINE***Staight Microsurgical Needle 3cm...
The Issue: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle with
The Issue: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with
The Issue: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is labeled in part: "***MEDLINE***Extended PTFE Needle 6.5" (16.51cm)
The Issue: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is labeled in part: "***MEDLINE***Extended PTFE Coated Needle with
The Issue: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade 6.5
The Issue: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product is labeled in part: "***MEDLINE***Extended 5mm PTFE Coated Ball
The Issue: On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEPARIN LOCK FLUSH SOLUTION
The Issue: CGMP Deviations: Incomplete documentation associated with test results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEPARIN LOCK FLUSH SOLUTION
The Issue: CGMP Deviations: Incomplete documentation associated with test results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Model 3500 Syringe Pump
The Issue: An issue with the plunger rod seal was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AperFix Femoral Implant Coring Removal Drill
The Issue: A review of product complaints in 2010 identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE HC OEC 9900 Elite and GE OEC 9800 Fluoroscopes
The Issue: GE OEC recalled certain 9800 Fluoroscope & 9900
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Computed Tomography X-Ray System. These devices are...
The Issue: Philips Healthcare discovered the customer was performing CTDI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.