Microstream CO2 sampling lines recalled for difficult adapter disconnection
Microstream CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended tube removal.
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 Class II FDA recall of a critical medical device. Although no illnesses or injuries have been reported, the potential for unintended extubation and respiratory failure during patient care qualifies it as a risk-of-harm product, meeting the criteria for High severity.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling Microstream CO2 sampling lines and filter line adapters used with endotracheal tubes for neonatal, infant, adult, and pediatric patients. Approximately 31,175 units have been distributed worldwide.
The recalled devices may be difficult or impossible to disconnect from endotracheal tubes during procedures such as suctioning. This disconnection difficulty may cause treatment delays and could result in unintended extubation (removal of the breathing tube).
Unintended extubation could lead to serious complications including respiratory failure, hypoxia (low oxygen levels), aspiration, and/or low oxygen saturation.
The recalled product
- Product
- Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV…
- Manufacturer
- Oridion Medical 1987 Ltd.
- Affected units
- 31,175
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 (4)
- D201260758)
- XS04620COV/10884521531529(D200322148
- D200742380)
- XS04624COV/10884521531536(D200320376)
Distribution
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 →Related recalls
Same manufacturer · Oridion Medical 1987 Ltd.
See all →- HighMicrostream CO2 Sampling Lines May Be Difficult to Disconnect From Breathing Tubes
FDA (Devices) · 2025-03-26
- HighMicrostream CO2 Sampling Line May Not Disconnect From Intubation Tube
FDA (Devices) · 2025-03-26
- HighCO2 Sampling Line Adapter May Be Difficult to Disconnect; Risk of Respiratory Failure
FDA (Devices) · 2025-03-26
- HighMicrostream neonatal CO2 filter lines difficult to disconnect from breathing tubes
FDA (Devices) · 2025-03-26
- HighMicrostream CO2 Intubated Filter Lines Difficult to Disconnect
FDA (Devices) · 2025-03-26
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