ZOLL MEDICAL CORPORATION

Activity by year

Devices registered here (1)

• Automated External Defibrillators (Non-Wearable)
  Product code MKJ (opens in a new tab) · Class III · Cardiovascular · 21 CFR 870.5310

Recalls & enforcement

• Class IIOngoing2025-02-13
  The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity).
• Class IIOngoing2024-05-31
  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 th…
• Class IOngoing2024-04-30
  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 …
• Class IIOngoing2019-06-12
  There is a potential for the device to fail to deliver energy to the patient.
• Class IITerminated2017-08-04
  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 Se…
• Class IITerminated2017-06-30
  A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user inadvertently changing device settings.
• Class IITerminated2014-03-05
  Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used
• Class IITerminated2012-08-16
  Shipped with incorrect software

FDA inspections (4)

• OAI2025-04-15
  Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
• VAI2016-10-18
  Voluntary Action Indicated · Compliance: Devices
• NAI2016-08-26
  No Action Indicated · Compliance: Devices
• NAI2016-04-08
  No Action Indicated · Project Evaluation: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

• Warning Letter2026-04-30
  Warning Letter (opens in a new tab) · Chelmsford Massachusetts

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

• All facilities operated by ZOLL Medical Corporation
• ZOLL Medical Corporation (WI)
• ZOLL International Holding B.V. (NL)
• ZOLL Circulation, Inc. (CA)
• ZOLL MEDICAL CORPORATION (MA)
• ZOLL Palm Springs (CA)
• ZOLL Medical Corporation (RI)

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)