Facility

PARKS MEDICAL ELECTRONICS, INC.

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

Key facts

1recalls · 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)	3020115
Establishment type	Manufacture Medical Device
Location	19460 SW SHAW ST ALOHA, OR, US 97007
Registration status	Active · expires 2026
Parent company	PARKS MEDICAL ELECTRONICS, INC. (owner-operator 9930003)
Brand names	811-B; 811-BL; 811-BTS; 842; 909; 841-A; 801-B; 812; 840; 915-BL; 806-CB; 810-A; 810-B

Activity by year

Recalls (1)
Inspections (2)

Devices registered here (1)

Flowmeter, Blood, Cardiovascular
Product code DPW (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2100

Recalls & enforcement

Class IITerminated2012-08-08
Parks Medical Electronics, Inc. was made aware of two incidents where an air supply tube from their PARKS PVR unit was inadvertently connected to an IV in the patient's arm instead of into the blood pressure cuff.

FDA inspections (2)

NAI2023-06-15
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2016-06-17
No 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 PARKS MEDICAL ELECTRONICS, 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. “PARKS MEDICAL ELECTRONICS, INC. (FEI 3020115) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3020115-parks-medical-electronics-inc/

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