Recall Z-2772-2026— AVID Medical, Inc.

Name: FDA recall Z-2772-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-19

Class II · Ongoing

Class II FDA medical device recall by AVID Medical, Inc., initiated 2026-05-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.. Reason: Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage..

Recalling firm: AVID Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-05-19
Firm location: Toano, VA, United States

Product description

Halyard STANDARD LINE INSERTION PACK. Model/Catalog Number: PVHM234-01. Convenience kit.

Reason for recall

Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage.

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