Oridion Medical recalls Microstream CO2 sampling lines for adults and pediatrics. Users may have trouble disconnecting the adapter from endotracheal tubes during suctioning, risking treatment delays or unintended extubation. This recall affects specific model numbers and serial numbers listed in the notice.
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 for adults and pediatrics. These devices may cause difficulty disconnecting the adapter from endotracheal tubes during suctioning procedures, which could lead to treatment delays, unintended extubation, or respiratory issues. Affected units include certain model numbers and serial numbers listed in the recall notice.
The CO2 sampling lines may not disconnect properly from endotracheal tubes during suctioning. This can cause treatment delays or unintended extubation, leading to respiratory failure, hypoxia, aspiration, or low oxygen saturation.
Healthcare providers using Microstream CO2 sampling lines for intubated patients, particularly during suctioning procedures. Patients on mechanical ventilation who require these devices are most at risk.
Check for the following model numbers: MVAI, MVAI100U, MVAIH, MVAIH100U, MVAIHH, MVAIHL, MVAIL, MVAMSK, MVASK, ZMVAIH, ZMVAIHH, or ZMVAI. Also look for the serial numbers listed in the recall notice.
Identify the model number (e.g., MVAI, MVAIHH) and serial number from the product description or packaging.
Reach out to Oridion Medical for assistance with verifying if your device is affected and obtaining replacement instructions.
The CO2 sampling lines may not disconnect properly from endotracheal tubes during suctioning, which can cause treatment delays or unintended extubation, leading to respiratory failure, hypoxia, aspiration, or low oxygen saturation.
Check for the model numbers listed in the recall (e.g., MVAI, MVAIHH) and the serial numbers provided in the notice. Affected units include specific combinations of model and serial numbers.
No, but you should check if your device is affected and contact Oridion Medical for guidance. The recall does not require immediate discontinuation but requires verification.
We’ve drafted a message you can send Oridion Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1384-2025 — Oridion Medical Oridion Medical Hello, I own a Oridion Medical that is covered by recall Z-1384-2025 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.
