DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF
Reported: November 19, 2025 Initiated: October 10, 2025 #Z-0446-2026
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.
Details
- Recalling Firm
- Medline Industries, LP
- Units Affected
- 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;
- Location
- Northfield, IL
Frequently Asked Questions
What product was recalled? ▼
DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO DYNJ909129D GENERAL LAPAROSCOPY-LF. Recalled by Medline Industries, LP. Units affected: 96,406 total units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2025. Severity: Critical. Recall number: Z-0446-2026.
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