Medline Industries, LP: Medical Device Recall in 2025 - (Recall #: Z-0450-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE

Product Classification:

Class I

Date Initiated: October 10, 2025

Date Posted: November 19, 2025

Recall Number: Z-0450-2026

Event ID: 97882

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.

Status: Ongoing

Product Quantity: 96,406 total units

Code Information:

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

Distribution Pattern:

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;

Voluntary or Mandated:

Voluntary: Firm initiated