Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

FDA Recall Z-1338-2026 · Posted 2026-02-09

Recalling FirmAVID Medical, Inc.
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2026-01-02
Product Quantity1,500 units

Reason for Recall

Tyvek bag seal issue which may compromise sterility of the kit.

Firm Action

AVID Medical notified consignees on about 01/02/2026 via emailed URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter. Consignees were instructed to segregate and quarantine all affected lots, discard all affected lots on hand, and complete and return the provided Recall Response form. Distributors were instructed to notify all customers if further distributed.

Root Cause

Equipment maintenance

Distribution Pattern

US Nationwide distribution in the states of New Jersey.

Official Source

View FDA Recall →

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

↑