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 30941–30960 of 38,428 recalls
Recalled Item: Accessory Kit
The Issue: The bottle assemblies were manufactured with a quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CODMAN 3000 Series Set- Huber needles. Used in combination
The Issue: Needle is leaking from hub/needle cannula connection
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Water Feed Kit
The Issue: The bottle assemblies were manufactured with a quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Water bottles
The Issue: The bottle assemblies were manufactured with a quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liquid Waste Bottle Kit
The Issue: The bottle assemblies were manufactured with a quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD...
The Issue: A potential issue was detected that could result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product
The Issue: A potential issue was detected that could result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liquid Waste Bottle
The Issue: The bottle assemblies were manufactured with a quality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Pediatric Flow Sensor Kit
The Issue: Reports of inaccurate low flow readings. Monitored inspiratory
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique
The Issue: The PedFuse Pedicle Screw Rod Caliper included with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sony Medical Monitor LMD-1951MD 19 inch
The Issue: Monitor has either not turned on or has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Millennium VG
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LCS COMPLETE RPS inserts
The Issue: The LCS COMPLETE RPS Knee System has higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LCS COMPLETE RPS Femoral Implants
The Issue: The LCS COMPLETE RPS Knee System has higher
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella
The Issue: The firm is recalling HardyCHROM SS, Cat. no
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diamondback 360 Coronary Orbital Atherectomy System
The Issue: The OAD saline sheath outer layer may flake
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation Radiation Therapy Treatment Planning System
The Issue: An issue with photon dose calculation for DMLC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LP Rotate Foot System prosthetic device for fitting lower extremity
The Issue: The threads of the outer tube of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Xi Surgical System
The Issue: Correction due to a fault that causes distal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci Xi Surgical System
The Issue: Correction due to a fault that causes distal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.