Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SenTec Membrane Changer Set (1 charger plus 1 insert) - Recalled by SenTec AG Due to There is an increased chance (approx. 5%) of...
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 SenTec AG directly.
Affected Products
SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.
Quantity: 3 sets
Why Was This Recalled?
There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SenTec AG
SenTec AG has 11 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report