Lower risk Medical device recall · FDA · Published May 2, 2019

SenTec Standard Starter Set Recall: Risk of Low Electrolyte During Membrane Change

SenTec recalls standard starter sets for potential low electrolyte during membrane changes. This may affect CO2 and oxygen monitoring in medical devices. Affected lots listed in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2153-2019Medical device SenTec ›

Lower-risk recall

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.

Take action

Contact the company

Recalling firmSenTec AGRingstrasse 39 · Therwil, Switzerland

✎ GovInfoNow plain-language explainer

SenTec is recalling its Standard Starter Set medical monitoring devices due to a risk of low or reduced electrolyte levels during membrane changes. This could impact the accuracy of oxygen and carbon dioxide monitoring in patients, especially neonates where oxygen monitoring is contraindicated. Read more at govinfonow.com/recall/67962-sentec-standard-starter-set-recall-risk-of-low-electrolyte-during.

Source Summary by GovInfoNow · govinfonow.com/recall/67962-sentec-standard-starter-set-recall-risk-of-low-electrolyte-during · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2153-2019

Cite this page

“SenTec Standard Starter Set Recall: Risk of Low Electrolyte During Membrane Change.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67962-sentec-standard-starter-set-recall-risk-of-low-electrolyte-during. Based on FDA recall #Z-2153-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2153-2019%22&limit=1).

The FDA announced on May 2, 2019, that SenTec AG is recalling its Standard Starter Sets due to a risk of insufficient electrolyte application during membrane changes. This Class II recall affects products distributed worldwide.

How to tell if you have it

SenTec Standard Starter Set
Lots: 180932, 180959, 181019, 181082, 190005, 190041, 190093, 190221, 190282
Standard Starter Set (without Service Gas) Lots: 180972, 190078

The hazard

According to the FDA, there is an approximately 5% chance that no electrolyte or a reduced amount of electrolyte will be applied to the sensor during the membrane change procedure.

Context

GovInfoNow's records show SenTec AG has issued four other recalls since December 10, 2020, including a July 25, 2023, recall for manufacturing defects and a May 2, 2023, recall for out-of-box failures. Other recent recalls of similar products include the Ventec V+Pro Ventilator (March 25, 2026), the NOxBOXi Nitric Oxide Delivery System (September 14, 2026), and the NOXBOX Nitric Oxide Delivery System (August 19, 2026).

How to tell if you have this one

Check the lot numbers listed: 180932, 180959, 181019, 181082, 190005, 190041, 190093, 190221, 190282 for the full set, and 180972, 190078 for the set without service gas.

Brand
SenTec
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Worldwide distribution - US Nationwide in the state of Missouri and countries of Argentina, Australia, Austria, Belgium, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Ecuador, Europe, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Israel, Italy, Kuwait, Malaysia, Finland, Portugal, Romania, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sri Lanka, Switzerland, Taiwan, Thailand, United Arab Emirates and United Kingdom.

Recall number	Product, codes & lots	Quantity
Z-2152-2019	SenTec Membrane Changer (reloadable) [9 pcs] - 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.; Lots: 180763, 180834, 180872, 180874, 180876, 180970, 180993, 181011, 181016, 181031, 181034, 181045, 181072, 181087, 181103, 181141, 190080, 190141, 190165, 190203, 190210, and 190264	198 pcs.
Z-2153-2019	SenTec Standard Starter Set with and without Service Gas (2 changers each) - 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.; Standard Starter Set Lots: 180932, 180959, 181019, 181082, 190005, 190041, 190093, 190221, and 190282. Standard Starter Set (without Service Gas) Lots:180972 and 190078	22 pcs
Z-2154-2019	SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - 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.; Neonatal Starter Set Lots: 181089, 190051 and 190242. Neonatal Starter Set (without Service Gas) Lots: 181068 and 190242	10 pcs
Z-2155-2019	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.; Lots: 180961, 181097, and 190053	3 sets
Z-2156-2019	SenTec Membrane Changer Insert [5 pcs - 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.]; Lots: 180759, 180766, 180788, 180814, 180830, 180831, 180837, 180839, 180868, 180869, 180870, 180918, 180933, 180938, 180941, 180984, 180996, 181014, 181027, 181035, 181059, 181070, 181083, 181092, 181100, 181142, 190016, 190028, 190032, 190073, 190088, 190100, 190125, 190143, 190163, 190170, 190215, 190236, 190240, 190262, and 190277	205 pcs

Based on the official FDA remedy

What to do — step by step

Check Lot Numbers
Identify the lot numbers from the list provided in the recall notice to determine if your device is affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide in the state of Missouri and countries of Argentina, Australia, Austria, Belgium, Chile, China, Columbia, Costa Rica, Czech Republic, Denmark, Ecuador, Europe, France, Germany, Greece, Guatemala, Hong…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

May 2, 2019Firm started the recall
Aug 5, 2019FDA classified it Class II
Aug 14, 2019Published in FDA’s Enforcement Report
Dec 16, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/67962-sentec-standard-starter-set-recall-risk-of-low-electrolyte-during">SenTec Standard Starter Set Recall: Risk of Low Electrolyte During Membrane Change (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-2153-2019 (May 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2153-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.