Browse Device Recalls

15 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 15 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 15 FDA device recalls.

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DateProductReasonClassFirm
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
Feb 13, 2025 Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... Class II ZOLL Medical Corporation
May 31, 2024 ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external def... G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the scr... Class II Zoll Medical Corporation
Apr 30, 2024 ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Oper... Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Pa... Class I ZOLL Medical Corporation
Jun 12, 2019 ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO ... There is a potential for the device to fail to deliver energy to the patient. Class II ZOLL Medical Corporation
Aug 4, 2017 OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 021... A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator ... Class II ZOLL Medical Corporation
Jun 30, 2017 731 Series Ventilators running software version 05.20.00 The devices in t... A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user... Class II ZOLL Medical Corporation
Mar 5, 2014 Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor W... Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used Class II ZOLL Medical Corporation
Aug 16, 2012 Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product ... Shipped with incorrect software Class II ZOLL Medical Corporation

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.