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Recall Observatory FDA recall evidence

Device product

Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; BREATHING KIT-LF DYNJ10550

Z-0443-2026

October 10, 2025

Class I

Product summary

Firm
Medline Industries, LP
Event
Event 97882
Status
Ongoing
Classification
Class I
Quantity
96,406 total units
Official record key
device-enforcement:Z-0443-2026

Official wording

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.

Code information: DYNJ10550 UDI-DI 40889942469704 (case), 10889942469703 (ea) Lot 25EBQ445

Distribution pattern: 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;

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.