Agency classClass IIOur severity:High FDA (Devices)·Z-1385-2025·Announced 2025-03-26

Microstream neonatal CO2 filter lines difficult to disconnect from breathing tubes

Microstream Advance neonatal-infant CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying critical procedures. This could cause unintended extubation and respiratory complications in infants.

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: FDA Class II recall affecting a high-risk neonatal respiratory device where malfunction could cause respiratory failure, hypoxia, or aspiration. Classified as a 'risk-of-harm product where injury has not yet been reported' under the rubric, as no illnesses or injuries have been documented despite serious potential consequences.

Plain-English summary

Microstream Advance neonatal-infant intubated CO2 filter lines are used to monitor carbon dioxide levels in infants receiving mechanical ventilation. The recall affects approximately 704,423 units distributed worldwide, including across all U.S. states and internationally.

The FDA has classified this as a Class II recall because the adapter may be difficult or impossible to disconnect from the endotracheal tube. When disconnection cannot be achieved, healthcare providers may be unable to perform necessary airway procedures such as suctioning.

Difficulty disconnecting the adapter may delay treatment and could result in unintended extubation (accidental removal of the breathing tube). These complications pose risks of respiratory failure, hypoxia, aspiration, and low oxygen saturation in vulnerable neonatal patients.

No deaths, illnesses, or injuries have been reported to the FDA. Healthcare providers using affected devices should contact their institutions' respiratory or biomedical teams for guidance and product verification.

The recalled product

Product: Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Microstream Advance Neonatal-Infant Intubated CO2 Filter Line 2m/6.5ft Extended Duration, MVIIH; Microstream Advance…
Manufacturer: Oridion Medical 1987 Ltd.
Category: Medical Device — Respiratory / Neonatal Airway
Hazard: difficult-disconnect
respiratory-failure
hypoxia
aspiration
Affected units: 704,423

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)

C220650235
C220858356
C220865467
C230417501
C231048771
C240417204
C240522125
C240624670
D181134920
D181134922
D201159585)
10884521761988(C210415594
C210525057
C211101243
C211105839
C211213507
C220103340
C220213101
C220213102
C220317965

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

Same hazard · difficult disconnect