The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1382-2025·Announced 2025-03-26

Microstream Neonatal-Infant CO2 Filter Line May Be Difficult to Disconnect

Microstream Neonatal-Infant Intubated CO2 Filter Lines may become difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially delaying treatment and causing unintended extubation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: This is an FDA Class II medical device with no reported illnesses or injuries. However, the recall addresses a risk-of-harm situation where difficulty disconnecting adapters could lead to treatment delays, unintended extubation, respiratory failure, hypoxia, and aspiration in critical care patients, meeting the criteria for High severity.

Plain-English summary

Oridion Medical 1987 Ltd. is recalling Microstream Advance Neonatal-Infant Intubated CO2 Filter Lines (Part Number PT00134354, Revision A) due to a disconnection difficulty issue. The device adapters may become difficult or impossible to disconnect from the endotracheal tube during routine clinical procedures such as suctioning.

If the adapter cannot be disconnected as intended, it may delay necessary treatment and cause unintended extubation. These complications could lead to respiratory failure, hypoxia (low blood oxygen), aspiration, and dangerously low oxygen saturation, particularly in neonatal and pediatric patients dependent on mechanical ventilation.

The recall affects approximately 350 units distributed worldwide, including throughout all regions of the United States and internationally. Affected healthcare facilities should immediately inspect their inventory for the recalled devices and contact Oridion Medical 1987 Ltd. for guidance on device replacement or corrective actions.

The recalled product

Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, QMVIIH
Manufacturer
Oridion Medical 1987 Ltd.
Category
Medical Device — Respiratory / Neonatal Critical Care
Hazard
Affected units
350

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 (1)

  • C211085494)

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 →

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