Recall Z-0448-2026— Medline Industries, LP

Name: FDA recall Z-0448-2026
Creator: U.S. Food and Drug Administration
Published: 2025-10-10

Class I · Ongoing

Class I FDA medical device recall by Medline Industries, LP, initiated 2025-10-10. It names one FDA 510(k) clearance: K213481. Product: Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING. 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..

Recalling firm: Medline Industries, LP
Classification: Class I
Status: Ongoing
Initiated: 2025-10-10
Firm location: Northfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K213481 — Medline General Surgery TrayMedline Industries, Inc.·cleared 2022-05-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET UP DYNJ909308D HIP PINNING

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.