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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 14 FDA device recalls.

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DateProductReasonClassFirm
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 piece of material may... Class II SenTec AG
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, the sensors stayed ... Class II SenTec AG
Aug 22, 2022 sentec 24 / MARe-SF Multi-Site Attachment Ring Easy, For sensitive / fragile ... Weak skin adhesion. Class II SenTec AG
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 SDM in home care sett... Class II SenTec AG
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 amount of electrolyte be... Class II SenTec AG
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 amount of electrolyte be... Class II SenTec AG
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 amount of electrolyte be... Class II SenTec AG
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 amount of electrolyte be... Class II SenTec AG
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 amount of electrolyte be... Class II SenTec AG
Sep 15, 2016 SDMS (SenTec Digital Monitoring System) Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Modu... Class II SenTec AG
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 deterioration of a part of the... Class II SenTec AG
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 not allow electroly... Class II Sentec AG
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 not allow electroly... Class II Sentec AG
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 configuration parame... Class II Sentec AG

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.