High FDA (Devices)·Z-1384-2025·Announced 2025-03-26

Microstream CO2 Sampling Line Disconnection Failure Poses Respiratory Risk

Microstream CO2 sampling adapters may become difficult or impossible to disconnect from endotracheal tubes, potentially delaying critical procedures and causing respiratory complications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II device with potential for serious respiratory complications including respiratory failure, hypoxia, and aspiration if the disconnection issue occurs during critical procedures. However, no illnesses or injuries have been reported, and the risk is described in conditional terms ('may' and 'could'), placing this at the High severity level per the rubric.

Plain-English summary

Oridion Medical 1987 Ltd. is recalling multiple Microstream CO2 sampling lines and adapters used in respiration monitoring across neonatal, infant, and adult-pediatric settings. The affected devices include intubated and oral-nasal filter lines distributed worldwide, including throughout the United States.

The devices may become difficult or impossible to disconnect from an endotracheal tube during patient care. This issue can prevent healthcare providers from performing necessary procedures such as suctioning and may result in unintended extubation. Potential consequences include respiratory failure, low oxygen saturation, hypoxia, and aspiration.

Healthcare facilities using these products should immediately inspect affected inventory for the specified lot and serial numbers and follow the manufacturer's instructions. Contact Oridion Medical 1987 Ltd. for guidance on product handling or replacement.

The recalled product

Product: Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI; Microst
Manufacturer: Oridion Medical 1987 Ltd.
Category: Medical Device — Respiratory / CO2 Monitoring
Hazard: disconnection-failure
respiratory-hazard
treatment-delay
extubation-risk
Affected units: 8,435,772

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

C221087559
C221192968
C230316355
C230519976
C230837238
C240522589
C240628663
C240729559
D191172616
D201158974
D210312139
D210622030
D210946062
D211154042)
10884521761889(C201200384
C210848192
C210961521
C211092998
C220210315
C220430764

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 10 recalled by Oridion Medical 1987 Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 10 products in this recall →

Same manufacturer · Oridion Medical 1987 Ltd.

See all →

High
Microstream neonatal CO2 filter lines difficult to disconnect from breathing tubes
FDA (Devices) · 2025-03-26
High
Microstream CO2 Sampling Line May Not Disconnect From Intubation Tube
FDA (Devices) · 2025-03-26
High
CO2 Sampling Line Adapter May Be Difficult to Disconnect; Risk of Respiratory Failure
FDA (Devices) · 2025-03-26
High
Microstream CO2 sampling lines recalled for difficult adapter disconnection
FDA (Devices) · 2025-03-26
High
Microstream CO2 Sampling Lines May Be Difficult to Disconnect From Breathing Tubes
FDA (Devices) · 2025-03-26

Same hazard · disconnection failure