Recall
FDAHealthOctober 10, 2025

Medline Industries, LP — Convenience Kit, BREAST HERNIA DYNJ909125G

⚠️ Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
October 10, 2025

International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;

What's affected?

Product
Convenience Kit, BREAST HERNIA DYNJ909125G
Lot code
25FBU543

Additional details

DYNJ909125G UDI-DI 40198459130664 (case), 10198459130663 (ea) Lot 25FBU543 25IBD459

What should I do?

Recommended action

Class I recall. Voluntary: Firm initiated Quantity affected: 96,406 total units.

View original FDA notice →

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