Medline Industries, LP — Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D
⚠️ 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; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D
- Lot code
- 25GBO685
Additional details
ENT DYNJ909128I UDI-DI 40198459333355 (case), 10198459333354 (ea) Lots 25GBO685; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D UDI-DI 40198459055301 (case), 10198459055300 (ea) Lots 25GBN602
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 96,406 total units.
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