Medline Industries, LP — Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 10, 2025
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;
What's affected?
- Product
- Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; OPEN HEART SUPPLEMENT DYNJ909116D; VASCULAR DYNJ909124F
- Lot code
- 25FBM604
Additional details
DYNJ909116D UDI-DI 40198459055356 (case), 10198459055355 (ea) Lots 25FBM604 25GBP604; DYNJ909124F UDI-DI 40198459130619 (case), 10198459130618 (ea) Lots 25FBB831 25GBI833
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 96,406 total units.
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