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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Apr 25, 2025 MUSE 5 Systems, Model Numbers 2021274-001, 2023032-005, 2027478-001, Large ca... The MUSE Administrator Account active directory or local credential could potentially be used fro... Class II GE Medical Systems Information Technologies Inc
Apr 22, 2024 Prucka 3 Amplifier Model #P1801PA used with CardioLab AltiX electrophysiology... Capacitors in certain Prucka 3 Amplifiers used with CardioLab / ComboLab systems could fail resul... Class II GE Medical Systems Information Technologies Inc
Apr 9, 2024 GE HealthCare CRITIKON ONE-CUF blood pressure cuffs, Model numbers: 1. ON... Use of the blood pressure cuffs could result in inaccurate non-invasive blood pressure measurements. Class II GE Medical Systems Information Technologies Inc
Aug 8, 2023 Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model... A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could ... Class II GE Medical Systems Information Technologies Inc
Jan 11, 2018 GE HEALTHCARE CARESCAPE Central Station (CSCS) software version 2.0.2 Th... CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (... Class II GE Medical Systems Information Technologies, Inc.
Jul 13, 2017 CARESCAPE Patient Data Module (PDM) v2.6 software used with CARESCAPE Monitor... Device does not produce a visual or audible impedance respiration APN alarm when an impedance res... Class II GE Medical Systems Information Technologies, Inc.
Feb 18, 2013 Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solut... It was reported from a complaint that study category labels of "Prior" and "Baseline" and hanging... Class II Ge Medical Systems Information T

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.