Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for Recalled by Lumenis Limited Due to Lumenis Ltd is recalling certain models of VersaCut...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Lumenis Limited directly.
Affected Products
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.
Quantity: 931 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Lumenis Limited
Lumenis Limited has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report