CLASS I Device recall · Reported 20 Feb 2013 · FDA Enforcement Report

VersaCut Tissue Morcellator recalled by Lumenis

Lumenis is recalling VersaCut Tissue Morcellator, distributed nationwide in the US. The recall was initiated on 2 Jan 2013 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel Numbers 0637-245-01 (starter kit) and 0636-470-01 (Control Box) which includes all products since initial product release 1998.

Quantity recalled931 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0795-2013
FDA event ID: 63858
Recalling firm: Lumenis, Yokneam
Classification: Class I
Status: Terminated
Recall initiated: 2 Jan 2013
FDA classified: 14 Feb 2013
Reported: 20 Feb 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Surgical Instruments

Timeline

2 Jan 2013	Recall initiated by company
14 Feb 2013	Classified by FDA	+43 days
20 Feb 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution - US Nationwide including: CA, WI, NC, FL, PA, IN, NM, NJ, IA, WA, OH, FL, MD, MA, WY, NY, AZ, NH, MN, TN, OK, KY, TX, AK, MI, VT. Internationally: Japan, Nepal, India, UK, South Korea, Netherlands, Germany, Australia, China, Canada, Turkey, Spain, Italy, Egypt, Mexico, Bulgaria, Utd. Arab, Emir., Poland, Kuwait, Hong Kong, Saudi Arabia, Yemen, Qatar, Czech Republic, New Zealand, Malaysia, Portugal, France, Argentina, Singapore, Romania, Chile, Colombia, Switzerland, Bahrain, Brazil, Serbia/Montenero, Taiwan, Israel, Indonesia, Peru, Pakistan, Nepal, Belarus, Latvia, Sri Lanka, Russian Fed, Thailand, Azerbaijan, Belgium, and Denmark.

Nationwide Alaska Arizona California Florida Iowa Indiana Kentucky Massachusetts Maryland Michigan Minnesota North Carolina New Hampshire New Jersey New Mexico New York Ohio Oklahoma Pennsylvania Tennessee

Questions about this recall

Why was it recalled?

Which lots are affected?

Model Numbers 0637-245-01 (starter kit) and 0636-470-01 (Control Box) which includes all products since initial product release 1998.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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