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 11781–11800 of 38,428 recalls
Recalled Item: BF-N20 OES Bronchofiberscope
The Issue: The firm is issuing validated, new reprocessing instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BF-P60 OES Bronchofiberscope
The Issue: The firm is issuing validated, new reprocessing instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BF-Q180-AC EVIS EXERA II Bronchovideoscope
The Issue: The firm is issuing validated, new reprocessing instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BF-XP160F EVIS EXERA Bronchovideoscope
The Issue: The firm is issuing validated, new reprocessing instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BF-P180 EVIS EXERA II Bronchovideoscope
The Issue: The firm is issuing validated, new reprocessing instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo.CT VA20A
The Issue: for data loss when using the contouring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo.via RT Image Suite with syngo.via VB30
The Issue: for data loss when using the contouring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR MAGNETOM Systems with RT Image Suite with syngo MR VA20A
The Issue: for data loss when using the contouring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Imperative Care
The Issue: There is a potential for distal end of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring
The Issue: Blood collection tubes may experience a clotting issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Allura Xper series is intended for use on human
The Issue: Early life failure of the ADUs only occurs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Azurion series (within the limits of the used Operation
The Issue: Early life failure of the ADUs only occurs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lyra Direct SARS-CoV-2 Assay Emergency Use Authorization- . The
The Issue: Revised Instructions for Use: Potential for specimens from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Allura Xper series is intended for use on human
The Issue: Early life failure of the ADUs only occurs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Universal Viewer 7.0
The Issue: A software anomaly exists in the Centricity Universal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EcoGel 100 Imaging Gel
The Issue: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel
The Issue: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel
The Issue: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EcoGel 100 - RED Medical Supplies Green Ultrasound Gel
The Issue: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LikoStretch Mod 600 IC Model Number: 3156065 LikoStretch Mod 600 IC
The Issue: Stretch Leveller has the potential to lose the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.