Recall Z-2192-2025— Phasor Health, LLC

Name: FDA recall Z-2192-2025
Creator: U.S. Food and Drug Administration
Published: 2025-03-21

Class II · Ongoing

Class II FDA medical device recall by Phasor Health, LLC, initiated 2025-03-21. It names one FDA 510(k) clearance: K161704. Product: Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35. Reason: Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time..

Recalling firm: Phasor Health, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-03-21
Firm location: Houston, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K161704 — Phasor DrillBiotex, Inc.·cleared 2016-12-01

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

Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35

Reason for recall

Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.

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