Facility

NONIN MEDICAL, INC.

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

Key facts

2recalls · 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)	2183646
Establishment type	Manufacture Medical Device
Location	13700 1ST AVE, NORTH Plymouth, MN, US 55441
Registration status	Active · expires 2026
Parent company	NONIN MEDICAL, INC. (owner-operator 2183646)
Brand names	Model 3245

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Oximeter, Wellness
Product code PGJ (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2700

Recalls & enforcement

Class IITerminated2016-09-29
Nonin manufactures and sells two 8500 handheld pulse oximeters (Model 8500 with no memory feature and the 8500M which has a memory feature). Some of the devices distributed may not have the correct pulse oximetry board with the integrated memory feature.
Class IITerminated2014-11-25
Nonin Medical is conducting a recall of certain regional oximetry sensors and associated products. They have received reports of signal loss during use of our shortcabled regional oximetry sensors with diaphoretic patients. No injury or illness have been reported.

FDA inspections (2)

NAI2024-07-18
No Action Indicated · Compliance: Devices
NAI2016-02-29
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 NONIN 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. “NONIN MEDICAL, INC. (FEI 2183646) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2183646-nonin-medical-inc/

Not open yet

Alerts for NONIN MEDICAL, INC.

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.