Recall Z-0927-2026— AVID Medical, Inc.

Name: FDA recall Z-0927-2026
Creator: U.S. Food and Drug Administration
Published: 2025-11-14

Class II · Ongoing

Class II FDA medical device recall by AVID Medical, Inc., initiated 2025-11-14. FDA's recall record names no specific 510(k) clearance for this event. Product: Halyard, EP LAB PK. Catalog Number: ESJH009-03.. Reason: Potential for incomplete seal on header bag..

Recalling firm: AVID Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-11-14
Firm location: Toano, VA, United States

Product description

Halyard, EP LAB PK. Catalog Number: ESJH009-03.

Reason for recall

Potential for incomplete seal on header bag.

Data sourced from openFDA. This site is unofficial and independent of the FDA.