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 36201–36220 of 38,428 recalls
Recalled Item: Aperio ScanScope System. Aperio ScanScope Models
The Issue: Aperio initiated this recall because the User Guides
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes 11-Hole
The Issue: The Synthes One-Third Tubular DCL Plate (11-Hole, 1/3
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Radial Head Prosthesis: Trial Radial Head Elbow joint prosthesis:
The Issue: The Trial Head may come loose from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kerr Maxcem Elite
The Issue: Kerr Corporation is initiating this recall because raw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The...
The Issue: Siemens Healthcare Diagnostics has initiated a voluntary field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OsteoSelect DBM Putty Product Usage: Orthopedic bone filler
The Issue: The firm's retesting procedure was not validated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device
The Issue: Siemens has confirmed complaints of low QC and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth
The Issue: Bard Access Systems is recalling two lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth
The Issue: Bard Access Systems is recalling two lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bipolar Cap
The Issue: The recall of the Loaner Bin and Sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 45 mm Screw
The Issue: The recall of the Loaner Bin and Sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Set Screw
The Issue: The recall of the Loaner Bin and Sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions
The Issue: The recall of the Loaner Bin and Sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 14 x 11 x 6mm 7 deg 14 x 11
The Issue: The recall of the Loaner Bin and Sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UKNEE Patella
The Issue: The recall of the Loaner Bin and Sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 12mm x 27mm x 8mm 12mm x 27mm x 9mm
The Issue: The recall of the Loaner Bin and Sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tibial baseplate
The Issue: The recall of the Loaner Bin and Sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: U2 Acetabular cup
The Issue: The recall of the Loaner Bin and Sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard
The Issue: The recall of the Loaner Bin and Sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ball Head
The Issue: The recall of the Loaner Bin and Sterilization
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.