sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For… recallZ-0148-2023 · SenTec AG · initiated Aug 22, 2022
Class II Terminated All recalls posted in October 2022
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from SenTec AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Weak skin adhesion.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm issued a letter to its consignees on 08/22/2022 regarding below standard adhesion properties of the MARe-SF (Multisite Attachment Rings - for Sensitive, Fragile skin) product containing replacement product in the form of the premium product - the Patient Application Kit (PAK-SF) and the recommendation to discard the affected product.
Recall details
- Recall number
- Z-0148-2023
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 22, 2022
- Posted by the FDA
- Oct 28, 2022
- Recalling firm
- SenTec AG
- Quantity
- 17208 units
- Product code
- LKD
- FDA submissions
- K151329
- Distribution
- US Nationwide distribution.
Product description
sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile skin. Used in continuous, noninvasive carbon dioxide and/or oxygen tension monitoring.
Code information (models, lots, serial numbers)
batch #220139
Other devices under the same FDA submission
6 devices cleared under K151329 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Membrane Changer (reloadable) / single unit MC-RSenTec AG · Oximeter, Ear1 recall0 reports
- Membrane Changer Inserts MC-ISenTec AG · Oximeter, Ear1 recall0 reports
- V-Sign™ Sensor 2 VS-A/P/NSenTec AG · Oximeter, Ear1 recall0 reports
- Membrane Changer (single-use) / single unit MCSenTec AG · Oximeter, Ear1 recall0 reports
- Sentec Digital Monitor SDMSenTec AG · Oximeter, Ear1 report
- Multi-Site Attachment Ring for mature/intact skin MARe-MISenTec AG · Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia1 death1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page