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 15781–15800 of 38,428 recalls
Recalled Item: NC TREK Coronary Dilatation Catheter
The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NC TREK Coronary Dilatation Catheter
The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NC TREK Coronary Dilatation Catheter
The Issue: Coronary Dilatation Catheters may exhibit difficulty or inability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JOURNEY II UNI RESECTION PREP TRIAL
The Issue: The spike rail was manufactured with an oversized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JOURNEY II UNI RESECTION PREP TRIAL
The Issue: The spike rail was manufactured with an oversized
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pedicle Screws
The Issue: An internal component was assembled in the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer
The Issue: When using the Rotor-Gene Q with Software version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iliac Screws
The Issue: An internal component was assembled in the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video
The Issue: Blades do not fit the McGRATH MAC video
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Protective Cover Vivo 55/65 (Used for Vivo 50/65)
The Issue: The outlet hole of the exhalation valve control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Truliant Splined Stem Extension
The Issue: These Truliant Splined Stem Extension, 18mm x 120mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans
The Issue: FridaBaby has been made aware through customer reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PREVI Isola Insrument and PREVI Isola Printer spares PSUs (power supply units)
The Issue: The recall has been initiated due to potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LN 3R70-01
The Issue: Abbott has identified potential performance issues for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS Pheno-Interventional Fluoroscopic X-Ray System Model Number: 10849000...
The Issue: exists for one or more axes of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DABRA Laser (RA-308 Excimer Laser). The DABRA Laser and DABRA
The Issue: A software issue was identified which could result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD System Battery Charger The HeartWare HVAD System is
The Issue: for an HVAD System user to mistakenly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD System Battery Charger AC Adapter The HeartWare HVAD
The Issue: for an HVAD System user to mistakenly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triton Canister System (finished part numbers FG 12009
The Issue: Some Canister Scanning Labels used to calibrate the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray BCID Panel
The Issue: There is an increased risk of false positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.