ZOLL Medical Corporation

10 FDA enforcement actions

10 Total Recalls

1 Class I

9 Class II

0 Class III

Firm Details

Product Types: device
States: MA, WI

All Recalls

Class II: Risk 02/13/2025 device

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 02/13/2025 device

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 02/13/2025 device

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 02/13/2025 device

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 02/13/2025 device

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 02/13/2025 device

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 02/13/2025 device

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 02/13/2025 device

The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Class II: Risk 05/31/2024 device

G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest
Class I: Dangerous 04/30/2024 device

Operator's Guide & Quick Reference Guide (QRG) ZOLL 731 Ventilator for MRI Compatible Devices. Patient Safety Ventilator MRI information omitted from the manuals. Update to the instructions ensures safe distance from the MRI to ensure proper function of the ventilator and reduce the risk of delay in ventilator therapy

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.