Zyno Medical has issued a Class I recall for 613 Z-800 series infusion pumps in the U.S. due to unvalidated software that could compromise safety functions like air-in-line detection, alarm volume, and reverse flow prevention. These faults may result in over- or under-infusion, air embolism, or blood clots, posing a risk of serious injury or death, according to the FDA.
Although no serious injuries have been reported from this recall, the issue follows prior software-related Z-800 recalls, including one in September 2024 linked to two injuries. Affected devices include the Z-800, Z-800F, Z-800W, and Z-800WF models.
Zyno is advising customers to stop using the pumps and await contact from distribution partner Intuvie for replacements. The Z-800 pump line was originally cleared by the FDA in 2007 under 510(k).
01-07-2025