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Browse Device Recalls

6 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 6 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 6 FDA device recalls.

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DateProductReasonClassFirm
Sep 16, 2025 Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 9... Due to two distinct issues: 1. During patient admission, patient demographic fields may default ... Class II Spacelabs Healthcare, Ltd.
Nov 25, 2024 Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-inva... Due to a manufacturing error the incorrect device serial number was potentially programmed into t... Class II Spacelabs Healthcare, Ltd.
Nov 25, 2024 Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive... Due to a manufacturing error the incorrect device serial number was potentially programmed into t... Class II Spacelabs Healthcare, Ltd.
Nov 6, 2020 Sentinel V10.x & V11.x, Models: 98200 & 98201 - Product Usage: designed using... During system upgrade incorrect comments may be added to existing tests. In such instance: Restin... Class II Spacelabs Healthcare, Ltd.
Jul 11, 2018 Arkon Anesthesia Delivery System with Arkon Software Version 2.70, Display Un... Arkon Anesthesia Delivery System may go into a failed state (mechanical ventilation ceases) while... Class I Spacelabs Healthcare, Ltd.
Oct 11, 2017 Arkon Anesthesia Delivery System, Model 99999, and software version 2.61 and ... Arkon Anesthesia Workstation, with software version 2.61, experienced failure in mechanical venti... Class I Spacelabs Healthcare, Ltd.

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.