Facility

NIDEK MEDICAL PRODUCTS, INC.

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

Key facts

1recalls · worst Class I

1inspections · 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)	1039215
Establishment type	Manufacture Medical Device
Location	3949 VALLEY EAST INDUSTRIAL DR Birmingham, AL, US 35217
Registration status	Active · expires 2026
Parent company	NIDEK MEDICAL PRODUCTS, INC. (owner-operator 1039215)
Brand names	Nuvo Nano Portable Oxygen Concentrator

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Generator, Oxygen, Portable
Product code CAW (opens in a new tab) · Class II · Anesthesiology · 21 CFR 868.5440

Recalls & enforcement

Class ITerminated2012-05-01
Capacitor failure may result in a fire hazard and loss of supplemental oxygen.

FDA inspections (1)

NAI2016-08-16
No Action Indicated · Compliance: Devices; Postmarket Assurance: 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 NIDEK MEDICAL PRODUCTS, 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. “NIDEK MEDICAL PRODUCTS, INC. (FEI 1039215) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1039215-nidek-medical-products-inc/

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