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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.