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Open, Classified

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

FDA Recall Z-0929-2026 · Posted 2025-12-15

Recalling FirmAVID Medical, Inc.
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2025-11-14
Product Quantity90 units

Reason for Recall

Potential for incomplete seal on header bag.

Firm Action

AVID Medical notified consignees on 11/14/2025 via emailed letter. Consignees were instructed to identify, segregate and quarantine all impacted product on hand, discontinue use of all affected units, and discard them. Distributors were instructed to notify customers if any of the affected kits were further distributed. Additionally, consignees were requested to complete and return the Recall Response Form.

Root Cause

Nonconforming Material/Component

Distribution Pattern

US distribution to GA, IL, NE, MD.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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