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 24421–24440 of 38,428 recalls
Recalled Item: Sterile Aquasonic 100 Ultrasound Transmission Gel
The Issue: There is a potential for the gel packets
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST OXACILLIN OX 256 US F100 In vitro diagnostic
The Issue: QC failures (MIC out of range high) for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic
The Issue: QC failures (MIC out of range high) for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9400 Laryngeal Strobe Product Usage: The 9310HD is used to
The Issue: Pentax Medical did not always provide transformers with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9200C and 9200D Laryngeal Strobe Product Usage: The 9310HD is
The Issue: Pentax Medical did not always provide transformers with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 7245C
The Issue: Pentax Medical did not always provide transformers with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 9310HD Digital Video Capture Modules Product Usage: The 9310HD is
The Issue: Pentax Medical did not always provide transformers with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is
The Issue: Software bug which allows parameters to be changed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access BR Monitor
The Issue: Following biases observed in the results of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV
The Issue: Six complaints were filed regarding loss of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS
The Issue: Product packaging may incorrectly include two bevel-tipped needles
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Art-Line Surgery Pack-LF
The Issue: Multiple surgical packs were assembled with a non-sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PICC Tray
The Issue: Multiple surgical packs were assembled with a non-sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiac Insulation Pad
The Issue: Complete delivery System (CDS) # CDS984746C was assembled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laparoscopy CDS
The Issue: One manufacturing lot of a non-sterile pack was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LASER CDS
The Issue: Multiple surgical packs were assembled with a non-sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dolphin Inflation Device
The Issue: The manufacturer of the DOLPHIN inflation device, Perouse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan
The Issue: An unexpected transient mode switch behavior was detected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Sensis
The Issue: An extremely dusty computer can cause problems at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit
The Issue: Maquet/Getinge is initiating a voluntary product removal involving
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.