Oridion Medical recalls Microstream CO2 sampling lines for neonatal and adult patients due to risk of treatment delay and respiratory failure if adapter cannot be disconnected during procedures like suctioning.
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 Microstream CO2 sampling lines that may cause difficulty disconnecting the adapter from endotracheal tubes during procedures like suctioning. This could lead to treatment delays, unintended extubation, or respiratory failure in patients.
The adapter may not disconnect properly from endotracheal tubes during procedures such as suctioning. This can cause treatment delays, unintended extubation, or respiratory issues like hypoxia and low oxygen saturation.
Healthcare providers using Microstream CO2 sampling lines for neonatal and adult patients are most at risk, particularly during procedures requiring tube disconnection like suctioning.
Check for Microstream Luer Intubated Adult Pediatric products with part number PT00156355 (Rev A) sold in the U.S. between 2021 and 2023. The product includes specific lot numbers listed in the recall notice.
Verify if your Microstream CO2 sampling line has part number PT00156355 (Rev A) with the listed lot numbers.
Reach out to Oridion Medical for guidance on safe use or alternative solutions if the product is still in use.
The adapter may not disconnect properly from endotracheal tubes during procedures like suctioning, which could cause treatment delays, unintended extubation, or respiratory failure.
Check for part number PT00156355 (Rev A) with the listed lot numbers in the recall notice.
No, but healthcare providers should be cautious during procedures requiring tube disconnection as the product may not disconnect properly.
We’ve drafted a message you can send Oridion Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1383-2025 — Oridion Medical Oridion Medical Hello, I own a Oridion Medical that is covered by recall Z-1383-2025 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.
