X-Guide Handpiece Adaptor Sleeve 1 — Class II medical device recall Z-1392-2024
Ongoing recall by X-NAV Technologies, LLC, reported 2024-04-10, distributed nationwide. The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in tu
| Recall number | Z-1392-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | X-NAV Technologies, LLC, Lansdale, PA, United States |
| Recall initiated | 2024-03-04 |
| Classified | 2024-03-29 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, JP |
| Quantity | 88 units |
| UPC / GTIN / UDI-DI | 00817421021480 |
| Lot numbers | 2308010012 |
| Model numbers | P010701 |
Product
X-Guide Handpiece Adaptor Sleeve 1, Model P010701
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1392-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.