Skip to content
Recall Observatory FDA recall evidence

Device product

STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790

Z-0757-2025

November 12, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95843
Status
Ongoing
Classification
Class II
Quantity
21,440 total
Official record key
device-enforcement:Z-0757-2025

Official wording

Reason: Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.

Code information: UDI: 00653160007671 (ea) 50653160007676 (case); Lot 2023012390

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    breach of sterility