Recall Z-0446-2026— Medline Industries, LP
Class I · Ongoing
Class I FDA medical device recall by Medline Industries, LP, initiated 2025-10-10. FDA's recall record names no specific 510(k) clearance for this event. Product: DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF. 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
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.