ZOLL Medical Corporation
FDA Regulatory Profile
ZOLL Medical Corporation appears in FDA public data with 15 recalls — including 1 Class I (most serious) —, 30 510(k) clearances, 25 FDA inspections, and 4 compliance actions on record. Its most recent recall (Z-1320-2025, Class II) was initiated on February 13, 2025. Its most recent 510(k) clearance was granted on December 13, 2024.
Summary
- Total Recalls
- 15 (1 Class I)
- 510(k) Clearances
- 30
- Inspections
- 25
- Compliance Actions
- 4
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1320-2025 | Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-01C, (2) G5S-02C, ( | February 13, 2025 |
| Z-1316-2025 | Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-00A, (2) G5A-01A, ( | February 13, 2025 |
| Z-1317-2025 | Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80A, (2) G5A-80A-TS | February 13, 2025 |
| Z-1318-2025 | Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-80C, (2) G5A-80C-TS | February 13, 2025 |
| Z-1323-2025 | Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80A; Software Version: | February 13, 2025 |
| Z-1319-2025 | Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5A-01C, (2) G5A-02C, ( | February 13, 2025 |
| Z-1322-2025 | Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) G5S-00A-TSO, (2) G5S-01 | February 13, 2025 |
| Z-1321-2025 | Class II | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-80C; Software Version: | February 13, 2025 |
| Z-2324-2024 | Class II | ZOLL Powerheart G5 AED, Semi-Automatic, G5Sxxx Family -Automated external defibrillator (AED) is des | May 31, 2024 |
| Z-2130-2024 | Class I | ZOLL 731 Ventilator (EMV+, AEV, Eagle II) - for MRI Compatible Devices - Operator's Guide and Quick | April 30, 2024 |
| Z-1931-2019 | Class II | ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to def | June 12, 2019 |
| Z-0977-2018 | Class II | OneStep CPR Complete, Adult Multi Function Electrodes, Part Numbers: 8900 0214 01 (case of 8 single | August 4, 2017 |
| Z-0812-2018 | Class II | 731 Series Ventilators running software version 05.20.00 The devices in the ZOLL ventilator are | June 30, 2017 |
| Z-1311-2014 | Class II | Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Ver | March 5, 2014 |
| Z-2401-2012 | Class II | Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used by qualified me | August 16, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233486 | 731 Series Ventilator | December 13, 2024 |
| K202375 | ZOLL Propaq M | March 9, 2021 |
| K180482 | ZOLL Propaq M | November 30, 2018 |
| K172653 | Power Infuser | July 18, 2018 |
| K162832 | 731 Series Ventilators | August 2, 2017 |
| K170533 | Model 330 Multifunction Aspirator | April 18, 2017 |
| K142915 | ZOLL X Series | December 3, 2014 |
| K141774 | ZOLL X SERIES | November 19, 2014 |
| K140502 | ZOLL E SERIES ALS | November 6, 2014 |
| K132488 | ZOLL CODE WRITER | April 3, 2014 |
| K131919 | ZOLL EPCR IOS | December 17, 2013 |
| K122839 | ZOLL SUREPOWER SINGLE BAY CHARGER | December 13, 2012 |
| K121865 | ZOLL RESCUENET 12-LEAD | November 20, 2012 |
| K121367 | ZOLL PROPAQ XM | June 21, 2012 |
| K110978 | ONESTEP PEDIATRIC MFE'S | May 13, 2011 |
| K103473 | ZOLL RESCUENET EPCR MODEL RESCUENET EPCR | May 13, 2011 |
| K110742 | ONESTEP ADULT MULTI-FUNCTION ELECTRODE | April 13, 2011 |
| K110526 | ZOLL AEDPRO WITH 2010 AHA GUIDELINES SOFTWARE UPDATE | March 25, 2011 |
| K091561 | ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE | September 23, 2010 |
| K090736 | POWER INFUSER, MODEL M100B-3A | May 20, 2009 |