FDA Device recall Z-0447-2026
Convenience Kit, BREAST HERNIA DYNJ909125G
- FDA Device
- Class I
- ongoing
- Published 2025-11-19
On 2025-11-19 the FDA classified a Class I recall of Convenience Kit, BREAST HERNIA DYNJ909125G by Medline Industries, citing 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 ina….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0447-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-10-10 |
| Published | 2025-11-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Convenience Kit, BREAST HERNIA DYNJ909125G
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.
Identifiers
| code_info | DYNJ909125G UDI-DI 40198459130664 (case), 10198459130663 (ea) Lot 25FBU543 25IBD459 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0447-2026%22
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