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SenTec AG

Complete recall history across all FDA and CPSC categories — 14 total recalls

SenTec AG appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (14)

FDA medical device enforcement actions by SenTec AG

Date Product Reason Class
Jul 25, 2023 Membrane Changer Single-Use, REF MC, each package contains 3 changers; Membra... During rework of components during the manufacturing process, an additional p... Class II
May 2, 2023 V-Sign Sensor 2, REF VS-A/P/N, a component of Sentec Digital Monitoring Syste... The sensors may experience an out-of-box failure because after recalibration,... Class II
Aug 22, 2022 sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile ... Weak skin adhesion. Class II
Dec 10, 2020 SenTec Digital Monitor, Model SDM, is a portable stand-alone patient monitor ... Device requires the use of an Isolation Transformer in combination with the S... Class II
May 2, 2019 SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for conti... There is an increased chance (approx. 5%) of no electrolyte or a reduced amou... Class II
May 2, 2019 SenTec Membrane Changer Set (1 charger plus 1 insert) - Product Usage: is ind... There is an increased chance (approx. 5%) of no electrolyte or a reduced amou... Class II
May 2, 2019 SenTec Neonatal Starter Set with and without Service Gas (2 Chargers each) - ... There is an increased chance (approx. 5%) of no electrolyte or a reduced amou... Class II
May 2, 2019 SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated fo... There is an increased chance (approx. 5%) of no electrolyte or a reduced amou... Class II
May 2, 2019 SenTec Standard Starter Set with and without Service Gas (2 changers each) - ... There is an increased chance (approx. 5%) of no electrolyte or a reduced amou... Class II
Sep 15, 2016 SDMS (SenTec Digital Monitoring System) Sentec AG found that with one batch of an internal SenTec Monitor component (... Class II
Mar 25, 2015 Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, S... SenTec is voluntarily replacing V-Sign Sensors 2 due to pre-mature deteriorat... Class II
Nov 5, 2012 SenTec V-Sign Membrane Changer (VS-MC), 9 pieces. The SenTec V-Sign Membrane... A manufacturing defect was observed for the membrane changer insert that does... Class II
Nov 5, 2012 SenTec V-Sign Membrane Changer Insert (VS-MCI), 5 pieces. The SenTec V-Sign ... A manufacturing defect was observed for the membrane changer insert that does... Class II
Jul 9, 2012 SenTec, V-Sign"2 Sensors The SenTec Digital Monitoring System (SMDS) is u... SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding ... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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