Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1379-2025 — Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 010991

U.S. FDA — Device Enforcement · Israel · 2025-02-17 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1379-2025
Date of alert
2025-02-17
Country / jurisdiction
Israel
Risk level
Class II
Risk type
recall
Brand
Oridion Medical 1987 Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
20884521762159
Reported risk: Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.