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 12361–12380 of 38,428 recalls
Recalled Item: FRESH DAY 1 DAY TORIC Power -07.50 -0.75/060 Daily Disposable
The Issue: Misaligned placement of an axis mark can cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CLARITI 1 DAY TORIC Power: -07.50 -0.75/060 Daily Disposable Contact
The Issue: Misaligned placement of an axis mark can cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Version: 1.2.0 (1.2.0+85ela410) Caption Health
The Issue: The firm is aware of a issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm
The Issue: Marketed without a 510K
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr....
The Issue: Marketed without a 510K
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm
The Issue: Marketed without a 510K
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr.
The Issue: Marketed without a 510K
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5 Fr IR PowerPICC Convenience Kit Catheter Dual Lumen with
The Issue: Catheter convenience kits contain the incorrect guidewire. Kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5Fr PowerPICC Catheter Single-Lumen with 70cm Guidewire Instructions For Use:
The Issue: Catheter kits contained the incorrect micro-introducers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENOSYL DS
The Issue: Reports received of NO measured below desired dose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LEGION Posterior Stabilized OXINIUM Femoral Component
The Issue: The device components experienced a manufacturing process error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cortoss Bone Augmentation Material 5cc Cartridge
The Issue: The products experienced a 12-hour excursion from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cortoss Bone Augmentation Material 10cc Cartridge
The Issue: The products experienced a 12-hour excursion from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ADVIA Chemistry XPT Chemistry System
The Issue: ADVIA Chemistry System and Software Versions (V1.4 SMN
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Herniatome
The Issue: The recalling firm was notified by the contract
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Herniatome
The Issue: The recalling firm was notified by the contract
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Herniatome
The Issue: The recalling firm was notified by the contract
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe
The Issue: The device may show unexpected locus specific signals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVSM3 SNF
The Issue: In some cases the equipment fails to power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JELCO HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE: a) 1.0mL 28G
The Issue: Specific models and lot numbers of the Jelco
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.