Microstream CO2 Sampling Line Disconnection Failure Poses Respiratory Risk
Microstream CO2 sampling adapters may become difficult or impossible to disconnect from endotracheal tubes, potentially delaying critical procedures and causing respiratory complications.
What this means for you
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 device with potential for serious respiratory complications including respiratory failure, hypoxia, and aspiration if the disconnection issue occurs during critical procedures. However, no illnesses or injuries have been reported, and the risk is described in conditional terms ('may' and 'could'), placing this at the High severity level per the rubric.
Plain-English summary
Oridion Medical 1987 Ltd. is recalling multiple Microstream CO2 sampling lines and adapters used in respiration monitoring across neonatal, infant, and adult-pediatric settings. The affected devices include intubated and oral-nasal filter lines distributed worldwide, including throughout the United States.
The devices may become difficult or impossible to disconnect from an endotracheal tube during patient care. This issue can prevent healthcare providers from performing necessary procedures such as suctioning and may result in unintended extubation. Potential consequences include respiratory failure, low oxygen saturation, hypoxia, and aspiration.
Healthcare facilities using these products should immediately inspect affected inventory for the specified lot and serial numbers and follow the manufacturer's instructions. Contact Oridion Medical 1987 Ltd. for guidance on product handling or replacement.
The recalled product
- Product
- Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 - Microstream Advance Adult-Pediatric Intubated CO2 Filter Line 2m/6.5ft Short-term use: Procedural/Emergency, MVAI; Microst
- Manufacturer
- Oridion Medical 1987 Ltd.
- Hazard
- disconnection-failure
- respiratory-hazard
- treatment-delay
- extubation-risk
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)
- C221087559
- C221192968
- C230316355
- C230519976
- C230837238
- C240522589
- C240628663
- C240729559
- D191172616
- D201158974
- D210312139
- D210622030
- D210946062
- D211154042)
- 10884521761889(C201200384
- C210848192
- C210961521
- C211092998
- C220210315
- C220430764
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27