Facility

ZOLL Manufacturing Corporation

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

2inspections · worst NAI

—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)	3008642652
Establishment type	Manufacture Medical Device
Location	121 Gamma Dr Pittsburgh, PA, US 15238
Registration status	Active · expires 2026
Parent company	ZOLL Manufacturing Corporation (owner-operator 9045611)
Brand names	LifeVest Wearable Defibrillator

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Wearable Automated External Defibrillator
Product code MVK (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IITerminated2017-09-12
Incorrect service code for properly catching critical defects during self-check. Potential for defibrillation shock failure

FDA inspections (2)

NAI2018-02-12
No Action Indicated · Compliance: Devices
NAI2016-07-15
No Action Indicated · Compliance: 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.

All facilities operated by ZOLL Manufacturing Corporation

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 Manufacturing Corporation (FEI 3008642652) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008642652-zoll-manufacturing-corporation/

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