CLASS II ONGOING Device recall · Reported 10 Apr 2024 · FDA Enforcement Report
X-Guide Handpiece Adaptor Sleeve recalled by X-NAV Technologies
X-NAV Technologies is recalling X-Guide Handpiece Adaptor Sleeve 1, distributed nationwide in the US. The recall was initiated on 4 Mar 2024 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-1392-2024
- FDA event ID
- 94175
- Recalling firm
- X-NAV Technologies, Lansdale, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Mar 2024
- FDA classified
- 29 Mar 2024
- Reported
- 10 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 4 Mar 2024 | Recall initiated by company | |
| 29 Mar 2024 | Classified by FDA | +25 days |
| 10 Apr 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.
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
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
Where it was distributed
Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.
Questions about this recall
Is X-Guide Handpiece Adaptor Sleeve 1 recalled?
Yes. X-NAV Technologies recalled X-Guide Handpiece Adaptor Sleeve 1 on 4 Mar 2024. The recall is Class II and its status is Ongoing. Recall number Z-1392-2024.
Why was it recalled?
The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.
Which lots are affected?
UDI-DI: 00817421021480; Lot: 2308010012
Where was it sold?
Worldwide distribution - US Nationwide and the countries of China, Europe, Japan.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from X-NAV Technologies
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | X-Guide Handpiece Adaptor Sleeve recalled by X-NAV Technologies | X-NAV Technologies | Device Malfunction | Nationwide |
| Device | CLASS II | X-Guide X-Mark Probe Tool -used recalled by X-NAV Technologies | X-NAV Technologies | Device Malfunction | Nationwide |
| Device | CLASS II | X-Guide Surgical Navigation System recalled by X-NAV Technologies | X-NAV Technologies | Foreign Material | 14 states |
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