Oridion Medical 1987 Ltd. 2025-03-26 Health serious FDA
Health · FDA · Recall #FDA-Z-1377-2025
Microstream Instructions for Use and Part Number used with - Product Description, REF: … Recall
Issued March 26, 2025 · Oridion Medical 1987 Ltd.
In March 2025, Oridion Medical 1987 Ltd. recalled the Microstream Instructions for Use and Part Number used with - Product Description, REF: …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using Microstream Instructions for Use and Part Number used with - Product Description, REF: … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Oridion Medical 1987 Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Oridion Medical 1987 Ltd.
- Category
- Health
- Recall date
- March 26, 2025
- Units affected
- Not reported
- Sold at
- Worldwide - US Nationwide distribution including in the states of TX, OH, FL, CO, IL, CA, MD, PA, VA, WI, IN, MI, NY, GA, OR, SC, NC, PR, AZ
- Recall number
- FDA-Z-1377-2025
- Made in
- Israel
- Issuing agency
- FDA
In context
- Oridion Medical 1987 Ltd. has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.