FDA Device recall Z-0795-2013
The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation an…
- FDA Device
- Class I
- terminated
- Published 2013-02-20
On 2013-02-20 the FDA classified a Class I recall of The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation an… by Lumenis, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0795-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-01-02 |
| Published | 2013-02-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Lumenis |
| Distribution | US |
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
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.
Identifiers
| code_info | Model Numbers 0637-245-01 (starter kit) and 0636-470-01 (Control Box) which includes all products since initial product release 1998. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0795-2013%22
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