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 11541–11560 of 38,428 recalls
Recalled Item: BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147
The Issue: Due to an increased risk of false positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GM Helix Acqua Implant 3.5x10
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VirtuTRAX Instrument Navigator
The Issue: There is potential that the VirtuTRAX device will
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VirtuTRAX Instrument Navigator
The Issue: There is potential that the VirtuTRAX device will
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VirtuTRAX Instrument Navigator
The Issue: There is potential that the VirtuTRAX device will
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VirtuTRAX Instrument Navigator
The Issue: There is potential that the VirtuTRAX device will
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transseptal Needle with Catheter. RPN TSN-17-75.0-ENDRYS. GPN G19261....
The Issue: Transseptal needles may contain rust on the interior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract...
The Issue: Product packaged as Beaver Xstar Crescent Knife, 2.5mm,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beaver Xstar Crescent Knife
The Issue: Product packaged as Beaver Xstar Crescent Knife, 2.5mm,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar
The Issue: Product packaged as Beaver Xstar Crescent Knife, 2.5mm,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transseptal Needle
The Issue: Transseptal needles may contain rust on the interior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes
The Issue: Product packaged as Beaver Xstar Crescent Knife, 2.5mm,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ComposiTCP 30 Interference screw D 7- L:25 mm
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioGlue Surgical Adhesive
The Issue: Product is not approved for use in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by
The Issue: The Aptio Automation Firmware for the ADVIA Centaur
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Red Dot Electrodes
The Issue: for breakage of the ECG electrode carbon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A. MENARINI diagnostics Hb 9210 PREMIER
The Issue: The Control Level I material value was showing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trinity Biotech HbA1c (GHb) Contorls Kit
The Issue: The Control Level I material value was showing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis
The Issue: System operator manual states that the system should
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE...
The Issue: Due to component (housing and plunger) detaching from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.