Recall Z-1387-2022— SONEX HEALTH LLC

Name: FDA recall Z-1387-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-29

Class II · Terminated

Class II FDA medical device recall by SONEX HEALTH LLC, initiated 2022-06-29, terminated 2023-04-14. It names one FDA 510(k) clearance: K192873. Product: SX-One MicroKnife. Reason: Potential of dull blade.

Recalling firm: SONEX HEALTH LLC
Classification: Class II
Status: Terminated
Initiated: 2022-06-29
Terminated: 2023-04-14
Firm location: Eagan, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K192873 — SX-One MicroKnifeSonex Health, Inc.·cleared 2019-12-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SX-One MicroKnife

Reason for recall

Potential of dull blade

Data sourced from openFDA. This site is unofficial and independent of the FDA.