# FDA recall Z-0446-2026

> **Medline Industries, LP** · Class I · device recall initiated 2025-10-10.

## Product

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.

## 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;

## Key facts

- **Recall number:** Z-0446-2026
- **Recalling firm:** Medline Industries, LP
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-10-10
- **Report date:** 2025-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0446-2026

## Citation

> AI Analytics. FDA recall Z-0446-2026. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0446-2026. Source: US FDA. Licensed CC0.

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