Oridion Medical recalls certain Microstream CO2 filter lines for neonatal and infant intubation. These lines may cause difficulty disconnecting during suctioning, risking treatment delays or unintended extubation.
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 CO2 filter lines used with infant intubation equipment. These lines can cause difficulty disconnecting during suctioning procedures, potentially leading to treatment delays or unintended extubation.
The filter lines 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 neonatal and infant intubation equipment with the recalled Microstream CO2 filter lines. Patients at risk include infants and neonates receiving mechanical ventilation.
Check for the part numbers: PT00156250 (Rev A) for the Microstream Advance Intubated CO2 Filter Lines, including models MVIIH, MVIIHH, MVIIHL, and ZMVIIH. These were sold with specific serial numbers listed in the recall notice.
Look for the part number PT00156250 (Rev A) on the filter line packaging or device.
Reach out to Oridion Medical for guidance on whether your specific model is affected and next steps.
The filter lines may not disconnect properly during suctioning, which can cause treatment delays or unintended extubation in infants and neonates.
The affected models include Microstream Advance Intubated CO2 Filter Lines with part number PT00156250 (Rev A), such as MVIIH, MVIIHH, MVIIHL, and ZMVIIH.
No, but you should check if your lines are affected and contact Oridion Medical for specific 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-1385-2025 — Oridion Medical Oridion Medical Hello, I own a Oridion Medical that is covered by recall Z-1385-2025 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.
