Z-0795-2013Class I

The Lumenis VersaCut Tissue Morcellator

Name: Z-0795-2013 The Lumenis VersaCut Tissue Morcellator
Creator: Lumenis Limited
Published: 2013-01-02
License: https://open.fda.gov/license/

Lumenis Ltd / initiated 2013-01-02 / Terminated / root cause: labeling and UDI

FDA source

Lumenis Limited began a recall of The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic visualization for the morcellation and removal of... on 2013-01-02. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0795-2013
Classification: Class I
Status: Terminated
Initiated: 2013-01-02
Posted: 2013-02-14
Terminated: 2013-05-20
Recalling firm: Lumenis Ltd
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.
Product code: GCJ Laparoscope, General & Plastic Surgery
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Lumenis sent an Urgent Safety Advisory Notice letter dated January 2, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to re-label the devices with the enclosed labels provided, replace the Operation Manual with the current revised Manual, complete the information requested on the Confirmation Card and return the Confirmation Card using the enclosed pre-paid shipping label by UPS. For question contact VersaCut Morcellator field correction administrator by either Cell: +972-(54)-9599196, Tel: +972-(4)-9599296 or E-mail: [email protected].
Quantity in commerce: 931 units
Distribution: 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.
Product codes and lots: Model Numbers 0637-245-01 (starter kit) and 0636-470-01 (Control Box) which includes all products since initial product release 1998.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0795-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0795-2013	Class I	Terminated	Voluntary: Firm initiated	2013-02-20	2013-02-14

Product code GCJ

K050639Class IILumenis Versacut Tissue Morcellator SystemLumenis, Inc. / cleared 2005-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)