Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported February 20, 2013
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.
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 …
Lumenis Limited recalled The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under di… - a critical-severity action.
The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under di… was recalled by Lumenis Limited in February 20, 2013. Reason: Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a r…. Check the official notice for the remedy. Verify recall #Z-0795-2013 with the FDA Devices before acting.
The recall
Lumenis Limited issued this critical-severity FDA Devices recall-Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a r….
- Critical
- severity level
- 931 units
- affected scope
- Class I
- classification
- February 20, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0795-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0795-2013) was formally reported on February 20, 2013, with the manufacturer initiating the action on January 2, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Lumenis Limited is listed as the recalling firm, operating out of Yokneam. Federal records list the affected scope as 931 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: 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, Netherlan…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
931 units
Related Recalls
6
3 from same agency
Product description
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 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-0795-2013 |
| Date reported | February 20, 2013 |
| Date initiated | January 2, 2013 |
| Recalling firm | Lumenis Limited |
| Firm location | Yokneam |
| Affected scope | 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, Austral… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0795-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Lumenis Limited. Units affected: 931 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 20, 2013. Severity: Critical. Recall number: Z-0795-2013.
Where was the recalled product distributed? ▼
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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0795-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 20, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.