DYNJ909119G ROBOTIC GASTRIC LAP SLEEVE-LF DYNJ909127F CYSTO… — Class I medical device recall Z-0446-2026
Ongoing recall by Medline Industries, LP, reported 2025-11-19, distributed nationwide. Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cra
| Recall number | Z-0446-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries, LP, Northfield, IL, United States |
| Recall initiated | 2025-10-10 |
| Classified | 2025-11-13 |
| Reported by FDA | 2025-11-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX, PA |
| Quantity | 96,406 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10198459055263, 10198459055423, 10198459130526, 40198459055264, 40198459055424, 40198459130527 |
| Lot numbers | 25FBP681, 25FBP819, 25FBV537, 25GBM605 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0446-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.