Magnolia Medical Technologies, Inc.

FDA Regulatory Profile

Magnolia Medical Technologies, Inc. appears in FDA public data with 2 recalls, 4 510(k) clearances, 5 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0318-2022, Class II) was initiated on November 2, 2021. Its most recent 510(k) clearance was granted on September 25, 2025.

Summary

Total Recalls
2
510(k) Clearances
4
Inspections
5
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0318-2022Class IIThe Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 November 2, 2021
Z-2393-2021Class IISteripath Luer Transport Pack, Gen2, Luer, BD - Product Usage: This holder/adapter assembly may be uAugust 2, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K251812Steripath® Flow™ Blood Collection SystemSeptember 25, 2025
K222299Steripath Micro Blood Collection SystemNovember 30, 2022
K200661Steripath Micro Blood Collection SystemOctober 8, 2020
K192247Steripath Gen2 Blood Collection SystemFebruary 28, 2020