Facility

ZOE MEDICAL, INC.

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

Key facts

2recalls · worst Class II

3inspections · 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)	3003294644
Establishment type	Manufacture Medical Device
Location	460 BOSTON ST. TOPSFIELD, MA, US 01983
Registration status	Active · expires 2026
Parent company	Zoe Medical, Inc (owner-operator 9041242)
Brand names	Ultraview DM3

Activity by year

Recalls (2)
Inspections (3)

Devices registered here (2)

System, Measurement, Blood-Pressure, Non-Invasive
Product code DXN (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1130
Oximeter
Product code DQA (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2700

Recalls & enforcement

Class IIOngoing2024-08-13
This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.
Class IITerminated2012-06-06
Unit fails to power up, resulting in an equipment alarm

FDA inspections (3)

VAI2024-05-31
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2019-09-20
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2016-10-12
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 Zoe Medical, Inc

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. “ZOE MEDICAL, INC. (FEI 3003294644) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003294644-zoe-medical-inc/

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