The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1380-2025·Announced 2025-03-26

CO2 Sampling Line Adapter May Be Difficult to Disconnect; Risk of Respiratory Failure

Microstream CO2 sampling line and airway adapter may be difficult or impossible to disconnect during procedures, potentially causing treatment delays and respiratory complications including hypoxia.

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 a FDA Class II recall involving medical equipment used in critical airway management. Although no illnesses or injuries have been reported, the defect poses a significant risk of serious harm including respiratory failure and hypoxia. Per the rubric, a risk-of-harm product where injury has not yet been reported scores as High (3).

Plain-English summary

Oridion Medical's Microstream CO2 Sampling Line and Adult-Pediatric Airway Adapter (OmniVentLine Set, part numbers 012808 and 012495) have been recalled due to a potential defect that may make the adapter difficult or impossible to disconnect from the endotracheal tube during patient procedures.

If the adapter cannot be disconnected as intended, it may cause treatment delays and unintended extubation. This could lead to serious respiratory complications including respiratory failure, hypoxia (low oxygen saturation), and aspiration.

The recall affects approximately 11,850 units distributed worldwide and throughout the United States. Patients and healthcare providers using these CO2 sampling lines should be aware of this potential disconnection issue. If you have used this product, contact your healthcare provider or Oridion Medical for guidance on replacement or further instructions.

The recalled product

Product
Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter, 012495;
Manufacturer
Oridion Medical 1987 Ltd.
Category
Medical Device — Respiratory / CO2 Monitoring
Hazard
Affected units
11,850

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)

  • D211155495)

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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