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 18761–18780 of 38,428 recalls
Recalled Item: Integra bioBLOCK Resorbable subtaler Implant
The Issue: Temperature indicator may have changed color to dark
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra bioBLOCK Resorbable subtaler Implant
The Issue: Temperature indicator may have changed color to dark
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra bioBLOCK Resorbable subtaler Implant
The Issue: Temperature indicator may have changed color to dark
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile...
The Issue: Two lengths of the 6.5mm RingLoc Hip System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile...
The Issue: Two lengths of the 6.5mm RingLoc Hip System
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laparotomy Sponge with the following product description and model numbers:
The Issue: lack of sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartSite Syringe Administration Set-Product Package Size 50
The Issue: Leaking of the Smartsite Syringe Administration Set. May
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biomet Small Diameter Cement Plug Inserter-Sterile
The Issue: Lack of an adequate sterilization validation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MultiDiagnost-Eleva
The Issue: The locking plate may be missing from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnidiagnost Classic
The Issue: The locking plate may be missing from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MultiDiagnost Eleva w/ Flat Detector
The Issue: The locking plate may be missing from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: URODiagnost Eleva
The Issue: The locking plate may be missing from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Urodiagnost
The Issue: The locking plate may be missing from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teleflex MEDICAL RuSCH One piece Male External Regular Catheter W/O Tape
The Issue: The device label incorrectly states that the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teleflex MEDICAL RuSCH One piece Male External Medium Catheter W/O Tape
The Issue: The device label incorrectly states that the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOOG Curlin Infusion Administration Set
The Issue: Administration sets leaked at the filter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOOG Curlin Infusion Administration Set
The Issue: Administration sets leaked at the filter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spine & Trauma 3D Navigation 1.0 (subpart of the system
The Issue: In certain occurrences, the affected navigation software application
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Consult Diagnostic Immunochemical Fecal Occult Blood Test
The Issue: Products were denied Clinical Laboratory Improvement Amendments (CLIA)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM
The Issue: During manufacturing, the screw stop ledge was not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.