DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF
FDA Recall #Z-0446-2026 — Class I — October 10, 2025
Product Description
DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF
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
CYSTO DYNJ909127F UDI-DI 40198459055424 (case), 10198459055423 (ea) Lots 25FBP819 25GBM605; GENERAL LAPAROSCOPY-LF DYNJ909129D UDI-DI 40198459055264 (case), 10198459055263 (ea) Lots 25FBV537; ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909119G UDI-DI 40198459130527 (case), 10198459130526 (ea) Lots 25FBP681
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated