Facility

ZOLL Circulation, Inc.

8 recall(s) on record — most severe on record: Class I.

Key facts

8recalls · worst Class I

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3003793491
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	2000 Ringwood Ave San Jose, CA, US 95131
Registration status	Active · expires 2026
Parent company	ZOLL Medical Corporation (owner-operator 1220908)
Brand names	STx Vest S/M; Surface Start-Up Kits; Thermogard HQ; Thermogard HQ Refurbished; Thermogard Surface System; Surface Start-Up Kit (CG-SURF); Thermogard XP Temperature Management System; Thermogard HQ Temperature Management System; Surface Temperature Management System; Thermogard HQ Surface Start-Up Kit (TGHQ-SURF); STx Surface Pad; STx Surface Pads

Activity by year

Recalls (8)
Inspections (2)

Devices registered here (1)

Hyperthermia Monitor
Product code NZE (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.5900

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 (2)

VAI2024-02-13
Voluntary Action Indicated · Compliance: Devices
VAI2017-11-09
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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.

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)

Cite this record

RegWarden. “ZOLL Circulation, Inc. (FEI 3003793491) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003793491-zoll-circulation-inc/

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