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Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
Mar 4, 2022 Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. F... Software issue resulting in temporary loss of central monitoring functionality. Class II Draegar Medical Systems, Inc.
Dec 23, 2020 Infinity Acute Care System (IACS) Monitoring Solution: The IACS is intended ... The Infinity M540 patient monitor may randomly reboot due to an error to correctly transmit and r... Class II Draegar Medical Systems, Inc.
Oct 9, 2019 Infinity M300 telemetry monitoring device Software versions VG2.3.1 and lower... The devices have potential cybersecurity vulnerabilities, which can include Distributed Denial of... Class II Draegar Medical Systems, Inc.
Sep 13, 2019 The Infinity Acute Care System (IACS) Monitoring Solution with the Standalone... Cybersecurity vulnerabilities may cause device to reboot, lose alarm functionality, and/or lose c... Class II Draegar Medical Systems, Inc.
Feb 8, 2019 Omega Systems These devices are intended to be used in the environment whe... The firm is recalling their Delta family of patient monitors software due to cybersecurity vulner... Class II Draegar Medical Systems, Inc.
Feb 8, 2019 Infinity Delta Family patient monitors The Infinity Delta Series (Delta/De... The firm is recalling their Delta family of patient monitors software due to cybersecurity vulner... Class II Draegar Medical Systems, Inc.
Mar 28, 2018 Infinity Acute Care System (lACS) Monitoring Solution; Catalog Numbers:MS2040... Software anomaly resulting in the loss of patient settings and stored patient data. Class II Draegar Medical Systems, Inc.
Feb 21, 2018 Infinity Acute Care System (IACS) Monitoring Solution, Catalog Numbers: MS188... The invasive pressure visual and audible alarms may not activate. Class II Draegar Medical Systems, Inc.
Oct 4, 2017 INFINITY DUAL HEMO MCable Pod Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinit... Class II Draegar Medical Systems, Inc.
Jun 6, 2017 Draeger Medical Systems Infinity Acute Care System (M540) Catalog Numbers: ... Cockpits with revision index 06 or higher that contain 4GB RAM modules may not annunciate audio o... Class II Draegar Medical Systems, Inc.
Mar 28, 2017 Kappa, Catalog Number: MS18853 in combination with Scio, Scio Four, Scio Four... It was reported that a set low O2 alarm does not go off although the measured O2 level is below t... Class II Draegar Medical Systems, Inc.
Mar 28, 2017 Delta XL, Catalog Number: MS18596 in combination with Scio, Scio Four, Scio F... It was reported that a set low O2 alarm does not go off although the measured O2 level is below t... Class II Draegar Medical Systems, Inc.
Mar 28, 2017 Delta, Catalog Number: MS18597 in combination with Scio, Scio Four, Scio Four... It was reported that a set low O2 alarm does not go off although the measured O2 level is below t... Class II Draegar Medical Systems, Inc.

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.