PlainRecalls
FDA Devices Critical Class I Ongoing

Convenience Kit, BREAST HERNIA DYNJ909125G

Reported: November 19, 2025 Initiated: October 10, 2025 #Z-0447-2026

Product Description

Convenience Kit, BREAST HERNIA DYNJ909125G

Reason for Recall

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.

Details

Recalling Firm
Medline Industries, LP
Units Affected
96,406 total units
Distribution
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;
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
Convenience Kit, BREAST HERNIA DYNJ909125G. Recalled by Medline Industries, LP. Units affected: 96,406 total units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 19, 2025. Severity: Critical. Recall number: Z-0447-2026.