The Lumenis VersaCut Tissue Morcellator Product Usage: is intended… — Class I medical device recall Z-0795-2013
Terminated recall by Lumenis Limited, reported 2013-02-20, distributed nationwide. Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a re
| Recall number | Z-0795-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lumenis Limited, Yokneam, Israel |
| Recall initiated | 2013-01-02 |
| Classified | 2013-02-14 |
| Reported by FDA | 2013-02-20 |
| Terminated | 2013-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, BE, BG, BH, BR, CA, CH, CL, CN, CO, CZ, DE, DK, EG, ES, FR, GB, HK, ID, IL, IN, IT, JP, KR, KW, LK, LV, MX, MY, NL, NP, NZ, PE, PK, PL, PT, QA, RO, RS, SA, SG, TH, TR, TW |
| Quantity | 931 units |
| Reason classes | labeling |
| Model numbers | 0637-245-01 |
Product
The Lumenis VersaCut Tissue Morcellator Product Usage: 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
Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism secondary to incorrect reversal tubing system hook-up.
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-0795-2013. 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.