Oridion Medical recalls Microstream airway adapters and CO2 sampling lines that may cause treatment delays or unintended extubation during suctioning, risking respiratory failure. Affected units include specific part numbers and revisions.
Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may experience difficulty/inability to disconnect adapter from endotracheal tube for procedures (e.g. suctioning), may cause treatment delay and/or unintended extubation, which could lead to respiratory failure, hypoxia, aspiration, and/or low oxygen saturation.
Oridion Medical is recalling airway adapters and CO2 sampling lines used with Microstream devices. If not properly disconnected during suctioning, these parts could cause treatment delays or unintended extubation, leading to respiratory failure or low oxygen levels.
The airway adapter may not disconnect properly from the endotracheal tube during suctioning procedures. This can cause treatment delays or unintended extubation, which may result in respiratory failure, hypoxia, or aspiration.
Healthcare providers using Microstream devices for neonatal, infant, or adult-pediatric patients are most at risk. The recall affects specific part numbers and revisions sold with the Microstream system.
Check for part numbers 01158 (Rev E), 010989, or 010991 on the Microstream device. The recall includes specific lot numbers and revisions listed in the product description.
Identify if your Microstream device has part numbers 01158 (Rev E), 010989, or 010991.
Reach out to Oridion Medical for specific instructions on handling the recalled items.
The airway adapter may not disconnect properly during suctioning, causing treatment delays or unintended extubation that could lead to respiratory failure or low oxygen levels.
Part numbers 01158 (Rev E), 010989, and 010991 are affected, along with specific lot numbers listed in the product description.
No immediate stop is required, but healthcare providers should check part numbers and contact Oridion Medical for guidance.
We’ve drafted a message you can send Oridion Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1379-2025 — Oridion Medical Oridion Medical Hello, I own a Oridion Medical that is covered by recall Z-1379-2025 from Oridion Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
