RecallRadar

FDA Device recall Z-0445-2026

Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits

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

AgencyFDA Device
Recall numberZ-0445-2026
ClassificationClass I
Statusongoing
Initiated2025-10-10
Published2025-11-19
Last updated2026-09-13 11:57 UTC
CompanyMedline Industries
DistributionUS

Product

Anesthesia Circuit Kits and other various kits that contain Anesthesia Circuits; ENT DYNJ909128I; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D

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
ENT DYNJ909128I UDI-DI 40198459333355 (case), 10198459333354 (ea) Lots 25GBO685; LARYNGOSCOPY - BRONCHOSCOPY DYNJ90911…ENT DYNJ909128I UDI-DI 40198459333355 (case), 10198459333354 (ea) Lots 25GBO685; LARYNGOSCOPY - BRONCHOSCOPY DYNJ909114D UDI-DI 40198459055301 (case), 10198459055300 (ea) Lots 25GBN602

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-0445-2026%22

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