In the last two years, a number of anesthesia recalls have affected thousands of devices and patients.
Here are four of the most notable recalls to know:
1. In 2023, Draeger Medical, or Dräger US, recalled more than 570,400 airway devices because of a manufacturing error that can lead to hypoxia and death. The Class I recall includes Seattle-Positive Airway Pressure Plus systems and 21 other breathing circuits and anesthesia kits.
2. In 2024, Draeger recalled 3,713 Perseus A500 anesthesia workstations following reports that the internal backup battery had failed spontaneously while the system was being operated off the main power supply.
3. In January, Provepharm issued a recall of its Phenylephrine hydrochloride injection, a blood pressure treatment common in anesthesia, from lot number 24020027 due to the discovery of black particulate matter in a vial. The affected lot, with an expiration date of December 2025, was distributed nationwide to hospitals and wholesalers.
4. On June 9, the FDA issued a Class I recall for multiple anesthesia breathing circuit kits manufactured by Draeger due to cracks in the hose that could cause inadequate ventilation. The affected products include VentStar 220 as well as Anesthesia Circuit Kit Flex 1, 2, 6, (P)2 and HEPA.
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