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 15441–15460 of 38,428 recalls
Recalled Item: Gentell Honey Hydrogel 2"x2" Saturated Gauze- A hydrating wound dressing
The Issue: During an FDA audit, it was discovered that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gentell Honey Hydrogel 4"x8" Saturated Gauze- A hydrating wound dressing
The Issue: During an FDA audit, it was discovered that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gentell Honey Hydrogel Hydrogel 4oz. Tube. Wound dressing containing hydrogel
The Issue: During an FDA audit, it was discovered that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gentell Honey Hydrogel 4"x4" Saturated Gauze- A hydrating wound dressing
The Issue: During an FDA audit, it was discovered that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neptune E-SEP 165mm Blade Electrode
The Issue: Due to a distribution error, product from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion Safe-T-Centesis Catheter Drainage Tray
The Issue: The 8 Fr catheter was manufactured with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xience Sierra TM Everolimus Eluting Coronary Stent System
The Issue: Incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD-Solis VIP ambulatory infusion pump
The Issue: Specific Pumps may exhibit intermittent performance in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B. Braun Introcan Safety IV Catheters
The Issue: Distribution of B.Braun Introcan Safety IV catheters without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triever20 Aspiration Guide Catheter a component of FlowTriever Retrieval/...
The Issue: The hemostasis valve of aspiration guide catheter devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Power supply provided with Afinion 2
The Issue: The analyzer system may have an electrostatic discharge
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Horizon PSU Stim Interconnecting Cable - Product Usage: Horizon is
The Issue: It was identified that there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rapid2 PSU Stim Interconnecting Cable - Product Usage: indicated for
The Issue: It was identified that there is a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Pleuravideoscope
The Issue: There was no data to validate that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Pleuravideoscope
The Issue: There was no data to validate that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LeMaitre 5F Plus Over the Wire Embolectomy Catheter
The Issue: There has been an increased trend in reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Utak NR Trace Elements Serum Control
The Issue: The product has an incorrect reference value for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifePAK 500 Automated External Defibrillator
The Issue: Automated External Defibrillators may not detect a patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Frames Direct Prescription Spectacle Lenses included in the frame brands
The Issue: The firm has become aware through their optical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X12+ and patient cable for the X12+ Telemeter with the
The Issue: Impacted Welch Allyn products may not meet the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.