Medline Industries, LP recalls Convenience kits

Recalling company

Medline Industries, LP

Product

Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE

Reason

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.

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

Oct 10, 2025

Reported

Nov 19, 2025

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;

Status

Ongoing

Quantity

96,406 total units

Lot / codes

GYN ROBOTIC DYNJ901046M UDI-DI 40198459130381 (case), 10198459130380 (ea) Lots 25FBM810 25GBK307; ROBOTIC PROSTATE DYNJ909120D UDI-DI 40198459130541 (case), 10198459130540 (ea) Lots 25GBT821 25IBF809

Company location

Northfield, IL

Recall type

Voluntary: Firm initiated

Recall number

Z-0450-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0450-2026 in the FDA Enforcement Report. Also see FDA recall press releases.