Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Capnostream 35 Portable Respiratory Monitor Recalled by Covidien Llc Due to The firm has released software update V01.05.02.16 (also...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Covidien Llc directly.
Affected Products
Capnostream 35 Portable Respiratory Monitor, Product numbers PM35MN02, PM35MN01, PM35MN05, DLPM35MN02 - Product Usage: use during both no motion and motion conditions and for patients who are well or poorly perfused.
Quantity: 3217
Why Was This Recalled?
The firm has released software update V01.05.02.16 (also known as V1.5.2) in response to customer reports of a false display of the message, "Temperature Exceeds Limits" followed by automatic shutdown of the monitor with no accompanying alarm.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Covidien Llc
Covidien Llc has 59 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report