Recall Record

Chelmsford, MA, United States

ZOLL Medical Corporation recalls

6 recalls recorded since 2018, most recently on 13 February 2025. 4 are listed as ongoing. Status and classification are as published by the FDA.

Recalls6
Ongoing (FDA)4
Terminated or completed2
Class I (FDA)1

Ongoing Class II Medical devices

Recall started
13 February 2025
Reason
The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
Distribution
Domestic: Nationwide Distribution International: AE, AI, AM, AR, AT, AU, BD, BE, BG, BH, BM, BN, BS, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EG, ES, FI, FR, GB, GH, GU, HK, HR, HU, ID, IE, IL, IN, IS, IT, JE, JM, JP, KR, KW, KZ, LB, LT, MA, MC, MD, ME, MQ, MS, MT, MX, MY, NC, NG, NL, NO, NZ, OM, PA
Initiated
Voluntary: Firm initiated
Recall numbers
Z-1321-2025, Z-1319-2025, Z-1320-2025, Z-1322-2025, Z-1316-2025, Z-1317-2025, Z-1318-2025, Z-1323-2025

Ongoing Class II Medical devices

Recall started
31 May 2024
Reason
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
Distribution
Nationwide including PR. Foreign: AU BM CA CH DE DK ES FR GB HK HU ID IE IL IT KR MA MT NL NO PR SA SE SI SN TR
Initiated
Voluntary: Firm initiated
Recall number
Z-2324-2024

Ongoing Class I Medical devices

Recall started
30 April 2024
Reason
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
Distribution
Worldwide distribution - US Nationwide and the countries of United Arab Emirates, Argentina, Australia, Azerbaijan, Bangladesh, Belgium, Bahrain, Bolivia, Brazil, Canada, Switzerland, China, Colombia, Czech Republic, Germany, Spain, Great Britain (UK), Greece, Guatemala, Guam, Hong Kong, Croatia,
Initiated
Voluntary: Firm initiated
Recall number
Z-2130-2024

Ongoing Class II Medical devices

Recall started
12 June 2019
Reason
There is a potential for the device to fail to deliver energy to the patient.
Distribution
Worldwide Distribution - US nationwide. The products were distributed to the following foreign countries: Austria, Australia, Bangladesh, Brazil, Canada, China, Denmark, France, Germany, Great Britain, Indonesia, Italy, Japan, Luxemburg, New Zealand, Panama, Russia, Saudi Arabia, Singapore, Spai
Initiated
Voluntary: Firm initiated
Recall number
Z-1931-2019

Terminated Class II Medical devices

Recall started
4 August 2017
Terminated
31 August 2018
Reason
A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator to deliver pediatric energy levels instead of adult energy levels when used with the ZOLL R Series Defibrillator. Defective electrodes will display PEDIATRIC PADS IN USE on the R Series defibrillator. Using the affected product with the M Series Defibrillator poses no risk.
Distribution
Worldwide Distribution - US Nationwide in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and in the countries of Canada.
Initiated
Voluntary: Firm initiated
Recall number
Z-0977-2018

Terminated Class II Medical devices

Recall started
30 June 2017
Terminated
9 October 2018
Reason
A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
Distribution
Outside US
Initiated
Voluntary: Firm initiated
Recall number
Z-0812-2018

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.