FDA Medical Device Recalls (openFDA)
Lumenis Limited: 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.
- Recall number
- Z-0795-2013
- Recalling firm
- Lumenis Limited
- 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.
- Status
- Terminated
- Initiated
- 2013-01-02
- Posted
- 2013-02-14
- Terminated
- 2013-05-20
- 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.
- 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: VersaCutMorcellator@lumenis.com.
- Quantity
- 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.
- Lot, serial or model codes
- Model Numbers 0637-245-01 (starter kit) and 0636-470-01 (Control Box) which includes all products since initial product release 1998.
- 510(k) numbers
- ["K050639"]
- PMA numbers
- not on file
- Product code
- GCJ
- Firm FEI
- 3004135191
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28