Oridion Medical recalls certain Microstream CO2 sampling lines and airway adapters for neonatal and adult/pediatric use. These devices may cause treatment delays or unintended extubation during suctioning procedures, risking respiratory failure or hypoxia.
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 specific Microstream CO2 sampling lines and airway adapters that may not disconnect properly during suctioning procedures. This could lead to treatment delays, unintended extubation, or respiratory issues for patients.
The recalled devices may not disconnect from endotracheal tubes during suctioning procedures. This can cause treatment delays, unintended extubation, or respiratory failure, hypoxia, aspiration, or low oxygen saturation in patients.
Healthcare providers using neonatal, infant, adult, or pediatric patients with these specific Microstream CO2 sampling lines and airway adapters. Patients at risk include those requiring mechanical ventilation or intubation.
Check for Microstream FilterLine or VitaLine sets with part numbers: 007737, 007768, 010579, 010580, 010787, 015016, 015021, XS04620, or XS04624. These were sold with specific lot numbers listed in the recall notice.
Identify if your Microstream device has part numbers listed in the recall notice (e.g., 007737, 007768, 010579, etc.)
If you have a recalled device, stop using it during suctioning procedures until a replacement is obtained
The recalled devices are Microstream FilterLine or VitaLine sets with part numbers including 007737, 007768, 010579, 010580, 010787, 015016, 015021, XS04620, or XS04624.
The devices may not disconnect properly from endotracheal tubes during suctioning procedures, which could cause treatment delays, unintended extubation, or respiratory issues.
Yes, if you have a recalled device, you should stop using it during suctioning procedures and replace it with a non-recalled model.
We’ve drafted a message you can send Oridion Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1377-2025 — Oridion Medical Oridion Medical Hello, I own a Oridion Medical that is covered by recall Z-1377-2025 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.