Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut… — Class II medical device recall Z-2770-2015
Terminated recall by Lumenis, reported 2015-09-23, distributed in CA, FL, MA, NY, PA. There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation pro
| Recall number | Z-2770-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lumenis, Yokneam, Israel |
| Recall initiated | 2015-07-30 |
| Classified | 2015-09-16 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2018-05-25 |
| Distributed | CA, FL, MA, NY, PA |
| Countries outside the US | AU, CN, DE, ES, FR, GB, IT, MX, PE, RU, TR, TW |
Product
Lumenis VersaCut+ Tissue Morcellator GA-0007500 The Lumenis VersaCut / VersaCut+ Tissue Morcellator System is intended for use under direct or endoscopic visualization for the morcellation and removal of dissected tissue during pelviscopic, laparoscopic, percutaneous, and open surgical procedures whenever access to the surgical site is limited.
Reason for recall
There is a probability the hand piece may operate inconsistently and unpredictably during the morcellation procedure resulting in damage to non-target tissue.
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-2770-2015. 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.