CLASS II ONGOING Device recall · Reported 6 Aug 2025 · FDA Enforcement Report
Phasor Drill recalled by Phasor Health
Phasor Health is recalling Phasor Drill, distributed in 28 states. The recall was initiated on 21 Mar 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2192-2025
- FDA event ID
- 97089
- Recalling firm
- Phasor Health, Houston, TX
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Mar 2025
- FDA classified
- 29 Jul 2025
- Reported
- 6 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 21 Mar 2025 | Recall initiated by company | |
| 29 Jul 2025 | Classified by FDA | +130 days |
| 6 Aug 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35
Where it was distributed
US: PA, IN, AZ, MO, LA, FL, TX, MA, OH, TN, MI, WV, VA, CA, DE, NH, GA, SC, GU, NY, NJ, MN, WI, NE, WA, IL, AR, PR, VT
ArkansasArizonaCaliforniaDelawareFloridaGeorgiaIllinoisIndianaLouisianaMassachusettsMichiganMinnesotaMissouriNebraskaNew HampshireNew JerseyNew YorkOhioPennsylvaniaPuerto Rico
Questions about this recall
Why was it recalled?
Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.
Which lots are affected?
UDI-DI: B775270S0, B775320L0, B7754500, B7755300, B7756350. Lot: 241002450, 241002530, 241009450, 241009530, 241016450, 241016530, 241023450, 241023530, 241030450, 241030530, 24112027S, 24121827S, 24122727S, 25012227S, 24082832L, 24102332L, 241227450, 241220635, 250122635, 241227530, 250122530.
Where was it sold?
US: PA, IN, AZ, MO, LA, FL, TX, MA, OH, TN, MI, WV, VA, CA, DE, NH, GA, SC, GU, NY, NJ, MN, WI, NE, WA, IL, AR, PR, VT
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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