Oridion Medical recalls adult and pediatric intubated filter lines that may cause treatment delays or unintended extubation during suctioning procedures, risking respiratory failure.
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 adult and pediatric intubated filter lines that can cause difficulty disconnecting the adapter during suctioning. This may lead to treatment delays or unintended extubation, which could cause respiratory failure or other serious complications.
The filter lines may not disconnect properly from the endotracheal tube during suctioning. This can cause treatment delays or unintended extubation, leading to respiratory failure, hypoxia, or aspiration.
Healthcare providers using these filter lines for intubated patients, especially during suctioning procedures. Patients on mechanical ventilation are most at risk.
Check for part numbers 10129497 (Rev B) with model codes 006324COV, XS04620COV, or XS04624COV. These lines were sold with the Microstream technology for adult and pediatric patients.
Look for part numbers 10129497 (Rev B) with model codes 006324COV, XS04620COV, or XS04624COV on the filter lines.
The filter lines may not disconnect properly from the endotracheal tube during suctioning, which can cause treatment delays or unintended extubation.
Using these filter lines may lead to treatment delays or unintended extubation, which could cause respiratory failure, hypoxia, or aspiration.
Check for part numbers 10129497 (Rev B) with model codes 006324COV, XS04620COV, or XS04624COV on the filter lines.
We’ve drafted a message you can send Oridion Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1378-2025 — Oridion Medical Oridion Medical Hello, I own a Oridion Medical that is covered by recall Z-1378-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
