ZOLL Medical Corporation

Complete recall history across all FDA and CPSC categories — 15 total recalls

ZOLL Medical Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (15)

FDA medical device enforcement actions by ZOLL Medical Corporation

Date Product Reason Class
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 ex... Class II
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 ex... Class II
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 ex... Class II
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 ex... Class II
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 ex... Class II
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 ex... Class II
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 ex... Class II
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 ex... Class II
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... Class II
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 Co... Class I
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
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 caus... Class II
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, whic... Class II
Mar 5, 2014 Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor W... Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop a... Class II
Aug 16, 2012 Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product ... Shipped with incorrect software Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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