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 37061–37080 of 38,428 recalls
Recalled Item: Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular
The Issue: Some units of Trilogy shells manufactured since March
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated
The Issue: Some units of Trilogy shells manufactured since March
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM
The Issue: Some units of Trilogy shells manufactured since March
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM
The Issue: Some units of Trilogy shells manufactured since March
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System
The Issue: Some units of Trilogy shells manufactured since March
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merit Medical's Custom Procedural Tray or Kits K12T-03162B &
The Issue: Custom Procedural Trays/Kits contain 0.9% Sodium Chloride Injection
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Minotrol 16
The Issue: HORIBA Medical Irvine Technical Support received reports from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX PENTRA Creatinine 120 CP
The Issue: This recall was initiated because some customers were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AdvanDx GNR Traffic Light PNA FISH
The Issue: GNR Traffic Light PNA Fish may have false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AdvanDx E. coli/P. aeruginosa PNA FISH
The Issue: E. coli Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gish 3/8 x 1/2" Reducer Connector with Luer fitting
The Issue: Due to a molding irregularity, certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gish 3/8 x 3/8" Straight Connector with Luer fitting
The Issue: Due to a molding irregularity, certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version
The Issue: Fluoroscan Mini C-Arm models -InSight2, version 4.0 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hologic Fluoroscan Mini C-Arm Model with InSight2
The Issue: InSight2, version 4.0 and 4.0.1 - DICOM images
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary...
The Issue: A complaint received from sales representative that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to
The Issue: Certain Samaritan 300/300P PAD devices may experience one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPT Femoral Stem 12/14 Neck Taper Extended Offset
The Issue: Zimmer Inc. is initiating a removal of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPT Modular Stem
The Issue: Zimmer Inc. is initiating a removal of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPT Hip System Femoral Stem Petite
The Issue: Zimmer Inc. is initiating a removal of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. 3M Steri-Vac
The Issue: 3M determined that the electrical grounding mechanism for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.