FemTouch delivery system includes the FemTouch Kit — Class II medical device recall Z-0301-2017
Terminated recall by Lumenis Limited, reported 2016-11-02. The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled d
| Recall number | Z-0301-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lumenis Limited, Yokneam, Israel |
| Recall initiated | 2016-09-25 |
| Classified | 2016-10-23 |
| Reported by FDA | 2016-11-02 |
| Terminated | 2017-04-11 |
| Countries outside the US | AE, AU, ES, GB, IN, IT, KW |
| Quantity | 69 units |
Product
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
Reason for recall
The cleaning instructions provided in FemTouch Operator's Manual might be ineffective for a fully assembled device and may lead to a potential for cross-contamination.
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-0301-2017. 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.