FDA Device recall Z-0444-2026
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits
- FDA Device
- Class I
- ongoing
- Published 2025-11-19
On 2025-11-19 the FDA classified a Class I recall of Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits 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-0444-2026 |
| 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
Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F
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 | DYNJ909116D UDI-DI 40198459055356 (case), 10198459055355 (ea) Lots 25FBM604 25GBP604; DYNJ909124F UDI-DI 4019845913061…DYNJ909116D UDI-DI 40198459055356 (case), 10198459055355 (ea) Lots 25FBM604 25GBP604; DYNJ909124F UDI-DI 40198459130619 (case), 10198459130618 (ea) Lots 25FBB831 25GBI833 |
|---|
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-0444-2026%22
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