Recall Z-0929-2026— AVID Medical, Inc.

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, MAJOR PACK. Catalog Number: JEMJ10-01.. 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, MAJOR PACK. Catalog Number: JEMJ10-01.

Reason for recall

Potential for incomplete seal on header bag.

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