Facility

MAGNOLIA MEDICAL TECHNOLOGIES, INC.

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

Key facts

2recalls · worst Class II

4inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3009976527
Establishment type	Manufacture Medical Device
Location	220 W Mercer St. Seattle, WA, US 98119
Registration status	Active · expires 2026
Parent company	Magnolia Medical Technologies (owner-operator 10042579)
Brand names	Steripath Micro Blood Collection System

Activity by year

Recalls (2)
Inspections (4)
Warning letters (1)

Devices registered here (2)

Tubes, Vials, Systems, Serum Separators, Blood Collection
Product code JKA (opens in a new tab) · Class II · Clinical Chemistry · 21 CFR 862.1675
Set, Administration, Intravascular
Product code FPA (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5440

Recalls & enforcement

Class IITerminated2021-11-02
Due to an uptick of complaints associated with premature needle retraction of blood collection system.
Class IITerminated2021-08-02
Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU).

FDA inspections (4)

VAI2025-07-10
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2022-04-06
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2021-07-15
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2017-02-23
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.

FDA warning letters (1)

Warning Letter2021-09-17
Warning Letter (opens in a new tab) · Seattle Washington

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

All facilities operated by Magnolia Medical Technologies

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. “MAGNOLIA MEDICAL TECHNOLOGIES, INC. (FEI 3009976527) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009976527-magnolia-medical-technologies-inc/

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