UnratedMedical device recall · FDA · Published April 3, 2026
Elekta Fletcher CT/MR Shielded Applicator Set Recall: Risk of IU Tube Detachment
Elek: Recall of Fletcher CT/MR Shielded Applicator Set due to potential IU tube detachment after use. Affected units may cause retained tissue in patients.
“Elekta Fletcher CT/MR Shielded Applicator Set Recall: Risk of IU Tube Detachment.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49546-elekta-fletcher-ct-mr-shielded-applicator-set-recall-risk-of. Based on FDA recall #Z-2710-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2710-2026%22&limit=1).
The FDA announced on April 3, 2026, that Elekta, Inc. is recalling the Fletcher CT/MR Shielded Applicator Set due to safety concerns regarding the detachment of the intrauterine tube tip. The agency issued recall number Z-2710-2026 for the Class II device.
The recall addresses the risk that the tip of the intrauterine tube may detach and remain within a patient during use. The FDA stated these are safety concerns regarding the device's integrity.
Context
GovInfoNow's records show Elekta, Inc. has issued 39 other recalls since June 19, 2017. Recent similar recalls include the Leksell Gamma Knife Perfexion and Icon models (Feb. 18, 2026) and the Leksell Vantage Arc System (March 19, 2026). Other recent recalls of similar products include the Medtronic GUNDRY Cannula Recall (April 21, 2026), the Medtronic Bio-Medicus Adult Cannula Kit Recall (May 25, 2026), and the Medline Urethral Catheter Tray Recall (May 4, 2026).
How to tell if you have this one
The product is labeled 'Fletcher CT/MR Shielded Applicator Set' for gynecological brachytherapy. It was sold with lot code 08717213024205.
Brand
Elekta
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TX, UT, VA, WI, and WV. The countries of Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Bolivia, Botswana, Brazil, Burkina Faso, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran (Islam Republic of), Iraq, Ireland, Italy, Japan, Kazakhstan, Kenya, Korea (Republic of), Kosovo, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Togo, Turkey, Ukraine, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.
Recall number
Product, codes & lots
Quantity
Z-2710-2026
Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.; Lot Code: 08717213024205
1
Z-2711-2026
Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.; Lot Code: 08717213055001, 08717213055018, 08717213055025, 08717213055049, 08717213055056, 08717213055063, 08717213055087, 08717213055094, 08717213055100, 08717213055117, 08717213055131
586
Z-2712-2026
Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial therapy.; Lot Code: 08717213056039, 08717213056053, 08717213056077, 08717213056091, 08717213056398, 08717213056411, 08717213056435, 08717213056459, 08717213056473, 08717213056497, 08717213056510,08717213056534, 08717213056558, 08717213056572, 08717213056596, 08717213056619, 08717213056633, 08717213056657
1317
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the product name 'Fletcher CT/MR Shielded Applicator Set' and lot code 08717213024205.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 35 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - U.S. Nationwide distribution including in the states of AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TX, UT, VA, WI, and WV. The countries of…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Virginia, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2710-2026 (April 3, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2710-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.