Official recall record
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 -
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-02-17
- Country of alert
- Israel
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10884521762374
- Brand on record
- Oridion Medical 1987 Ltd.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2025-02-17 · US FDA — Medical Devices
Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & V - 2025-02-17 · US FDA — Medical Devices
Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and - 2025-02-17 · US FDA — Medical Devices
Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 0
All 9 official recall notices naming Oridion Medical 1987 Ltd. on this site →
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