Facility

TZ MEDICAL, INC.

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

Key facts

4recalls · worst Class II

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)	1000127185
Establishment type	Manufacture Medical Device
Location	20497 Sw Teton Ave Tualatin, OR, US 97062
Registration status	Active · expires 2026
Parent company	TZ MEDICAL, INC. (owner-operator 9006202)
Brand names	ARC Band

Activity by year

Recalls (4)
Inspections (2)

Devices registered here (1)

Clamp, Vascular
Product code DXC (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.4450

Recalls & enforcement

Class IITerminated2016-07-07
Neptune Plus was mis-labeled and included the statement WITH ANTIMICROBIAL BARRIER. This statement should not appear on label.
Class IITerminated2015-10-14
The IFU of the Neptune Plus Pads, does not match that submitted in the original 510k. Need to remove: for haemostasis following needle/sheath removal
Class IITerminated2015-10-14
During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in the original 510k
Class IITerminated2013-04-30
TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly. If a failure were to occur, the end user would be able to identify the fai…

FDA inspections (2)

NAI2017-05-03
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2016-07-13
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.

All facilities operated by TZ 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. “TZ MEDICAL, INC. (FEI 1000127185) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000127185-tz-medical-inc/

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