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 21561–21580 of 38,428 recalls
Recalled Item: Accelerate PhenoTest BC kit
The Issue: The kits may produce an elevated rate of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray BCID Panel (Blood Culture Identification Panel)
The Issue: There is an increased risk of false positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WRIGHT
The Issue: Tow lot of VALOR(TM) Nail could potentially be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inspire 8 Integrated Phisio OXY w/ HVR Reservoir
The Issue: Some integrated sterile INSPIRE family products contain an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inspire 6 Integrated Phisio OXY w/ HVR Reservoir
The Issue: Some integrated sterile INSPIRE family products contain an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Prestige LP(TM) Cervical Disc System with Streamlined Instruments
The Issue: The firm received complaints of drill bits breaking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic DxTerity Diagnostic Catheter
The Issue: The color coded French size indicator on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genesis Surgical Cassette Tapered Implants are intended for placement following
The Issue: The surgical cassette contained extra-large white grommets making
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Cardiology Hemo
The Issue: Change Healthcare has identified an issue where, under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vacuum Regulator
The Issue: Final quality control testing was not completed before
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trident Endoscopic Ultrasonic Biopsy Needle (FNB)
The Issue: The combination of the firmness of the mass,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trident Endoscopic Ultrasonic Aspiration Needle (FNA)
The Issue: The combination of the firmness of the mass,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fischer Cone Biopsy Excisor
The Issue: Products have been packaged with an incorrect product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults
The Issue: After two and a half years, the battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syva¿ EMIT¿ II Plus 6-Acetyl morphine Catalog # for 28
The Issue: Incorrect calibrator level listed in qualitative calibration steps
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syva¿ EMIT¿ II Plus 6-Acetylmorphine Catalog # for 1000 mL:
The Issue: Incorrect calibrator level listed in qualitative calibration steps
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5 mm Apple-Hunt Secondary Cannula/Pyramidal Tip Trocar - extended length
The Issue: Products have been packaged with the wrong Trocar
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hinge Coupling Hoffmann LRF Catalog # 4933-0-800 Intended for fixation
The Issue: The wrong parts were picked for packaging. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Power-LOAD Cot Fastening System
The Issue: The power load floor plates which hold the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Patient-Fitted Temporomandibular (TMJ) Right Mandibular Component part of...
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.