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Open, Classified

Halyard, Pain Pack. Kit Code: AMPK48-01.

FDA Recall Z-2407-2026 · Posted 2026-06-11

Recalling FirmAVID Medical, Inc.
Recall StatusOpen, Classified
Product CodeOJH
Date Initiated2026-04-30
Product Quantity120 kits

Reason for Recall

Inadvertent distribution of sealed pouches that had not undergone validated sterilization.

Firm Action

AVID Medical notified consignees on about 04/30/2026 via emailed letter. Consignees were instructed to identify, segregate and quarantine all affected units on hand, discard all impacted kits and complete and return the provided Response Form. Distributors were instructed to ensure all end-users are appropriately notified and maintain records of effectiveness.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the state of Iowa.

Official Source

View FDA Recall →

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

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