The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1383-2025·Announced 2025-03-26

Microstream CO2 Sampling Line May Not Disconnect From Intubation Tube

Microstream intubated CO2 sampling lines may be difficult or impossible to disconnect from endotracheal tubes. This could delay necessary procedures and cause unintended extubation, potentially leading to respiratory failure.

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 recall with documented risk-of-harm potential (respiratory failure, hypoxia, aspiration). However, no illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported score at most 3.

Plain-English summary

This recall affects Microstream Luer Intubated Adult-Pediatric CO2 Sampling Lines (Part Number PT00156355, Revision A, MLAI). These devices measure end-tidal carbon dioxide levels during anesthesia, emergency intubation, and procedural sedation in adult and pediatric patients.

The recalled sampling lines may be difficult or impossible to disconnect from the endotracheal tube adapter. This connection failure could prevent clinicians from accessing the airway for essential procedures such as suctioning, potentially causing treatment delays.

If the adapter cannot be disconnected, an unintended extubation may occur when attempting to remove it. This could result in respiratory failure, hypoxia (low blood oxygen), aspiration, or significant drops in oxygen saturation. Approximately 62,877 units have been distributed worldwide, including across all U.S. states and numerous international locations.

Healthcare facilities and providers should immediately discontinue use of the recalled sampling lines. The affected lot numbers are specified in the FDA recall notice. Contact the manufacturer or consult FDA resources for guidance on device return or replacement.

The recalled product

Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI
Manufacturer
Oridion Medical 1987 Ltd.
Category
Medical Device — Respiratory/Anesthesia Equipment
Hazard
Affected units
62,877

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 (17)

  • C210103391
  • C210103392
  • C220100198
  • C220101566
  • C220210015
  • C220212812
  • C220430762
  • C220650161
  • C220975826
  • C221087553
  • C230208559
  • C230627706
  • C230733095
  • C240624686
  • D201159627
  • D201262180
  • D210206012)

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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