Oridion Medical recalls OmniVentLine Set CO2 sampling lines due to risk of treatment delays and unintended extubation during suctioning procedures.
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 recalls certain OmniVentLine Set CO2 sampling lines because they may not disconnect properly during suctioning, risking treatment delays or unintended extubation. This could lead to respiratory failure or low oxygen levels in patients.
The CO2 sampling lines may not disconnect safely from endotracheal tubes during suctioning procedures. This can cause treatment delays or unintended extubation, potentially leading to respiratory failure, low oxygen levels, or aspiration.
Healthcare providers using the OmniVentLine Set CO2 sampling lines with infants, children, or adults during medical procedures. Patients receiving respiratory support are most at risk.
Check for the part number 012495 or 012808 on the device. The product was sold with the OmniVentLine Set Adult-Pediatric CO2 Sampling Line and Airway Adapter.
Look for part numbers 012495 or 012808 on the device label.
The CO2 sampling lines may not disconnect properly during suctioning, causing treatment delays or unintended extubation that could lead to respiratory failure or low oxygen levels.
Check the device label for part numbers 012495 or 012808. If you have the product, contact Oridion Medical for instructions.
Yes, the recall states that improper disconnection could lead to respiratory failure, hypoxia, or aspiration.
We’ve drafted a message you can send Oridion Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1380-2025 — Oridion Medical Oridion Medical Hello, I own a Oridion Medical that is covered by recall Z-1380-2025 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.
