Convenience Kits: DYNJ901048N ORTHO SPINE ST CLAIR DYNJ909123F UROLOGY MINOR DYNJ909132F SET U...
FDA Recall #Z-0448-2026 — Class I — October 10, 2025
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.
Recalling Firm
Medline Industries, LP — Northfield, IL
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Product Quantity
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;
Code Information
HIP PINNING DYNJ909308D UDI-DI 40198459055288 (case), 10198459055287 (ea) Lots 25FBB311 25GBC282 25GBW486; ORTHO SPINE ST CLAIR DYNJ901048N UDI-DI 40198459055554 (case), 10198459055553 (ea) Lots 25GBQ070; SET UP DYNJ909132F UDI-DI 40198459130572 (case), 10198459130571 (ea) Lots 25GBI845 25IBF708; UROLOGY MINOR DYNJ909123F UDI-DI 40198459130602 (case), 10198459130601 (ea) Lots 25GBT826 25IBF707
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated