The FDA recently shared information about recalls for:
- Closed Suction Catheter Recall:Avanos Medical, Inc. Removes Ballard Closed Suction Systems Due to Risk of Non-Sterility
- Infant Breathing System Recall:AirLife/Vyaire Removes Infant Heated Wire Circuits Due to Risk for Inadvertent Adapter Disconnection During Ventilation
- Broselow Pediatric Emergency Rainbow Tape Recall:AirLife Removes Certain Broselow Pediatric Emergency Rainbow Tapes due to Misprinted Information
Through the Communications Pilot to Enhance the Medical Device Recall Program, the FDA has committed to improve the timeliness of communications about corrective actions being taken by companies that the FDA believes are likely to be high-risk recalls. However, the FDA may not yet have determined that the actions meet the regulatory definition of a recall. These actions may include when companies remove products from the market, correct products, or update instructions for using products due to potentially high safety risks.
The FDA will keep the public informed and update our website as significant new information becomes available.
The FDA lists the most serious type of medical device recalls as well as early alert communications about corrective actions being taken by companies that the FDA believes are likely to be the most serious type of recalls on our website by the date that the FDA posts the information on our website.
For details, visit https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
