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 11761–11780 of 38,428 recalls
Recalled Item: SARS-CoV-2 Process Control (Swab) - Product Usage: intended for use
The Issue: The product indicated is contaminated with a plasmid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LiquaSonic Ultrasound Gel 250mL
The Issue: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LiquaSonic Ultrasound Gel 5L
The Issue: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monoject 0.9% Sodium Chloride
The Issue: Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
The Issue: The rear heater plate and cover assembly that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Ultrasound
The Issue: Battery system data issue with the ultrasound system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Ultrasound
The Issue: Battery system data issue with the ultrasound system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Scrip Ultrasound Gel Clear
The Issue: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Scrip Creme All Purpose Lotion Intended for use in acoustic
The Issue: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COVENA PICC Sleeve
The Issue: Marketed without FDA clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed tomography x-ray systems with software syngo.CT VA20A_SP4a
The Issue: Software versions may result in sporadic problems causing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoLink Bone Graft Harvester
The Issue: Complaints were received of CoLink Bone Graft Harvesters
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA BF-XT160 Bronchofibervideoscope
The Issue: A gluing step was not performed during the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BF-XP60 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: Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08
The Issue: When deleting a previously entered custom isotope, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BF-1T180 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-3C40 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-XT160 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: AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08
The Issue: When deleting a previously entered custom isotope, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BF-1T60 OES Bronchofiberscope
The Issue: The firm is issuing validated, new reprocessing instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.