FDA recall, , Moderate risk
Elekta Brachytherapy Applicators
The Fletcher CT/MR Shielded Applicator Set can detach its intrauterine tube tip, which may remain within a patient.
Summary by Recall Canary from the FDA notice
What happened
Elekta, Inc. of Atlanta, Georgia began a recall on April 3, 2026, for the Fletcher CT/MR Shielded Applicator Set, the Advanced Gynecological Applicator, and the Brachytherapy Applicator (Geneva) due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
The FDA added the recall to its Enforcement Report and classified it on July 9, 2026, with the weekly report on July 15, 2026. Distribution was worldwide, including nationwide U.S. states and numerous countries.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
3 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Brachytherapy Applicator Advanced Gynecological Applicator
- UDI-DI
- 08717213055001
- 08717213055018
- 08717213055025
- 08717213055049
- 08717213055056
- 08717213055063
- 08717213055087
- 08717213055094
- 08717213055100
- 08717213055117
- 08717213055131
Fletcher CT/MR Shielded Applicator Set Intracavitary Remote Afterloading Applicator
- UDI-DI
- 08717213024205
Geneva Brachytherapy Applicator
- UDI-DI
- 08717213056039
- 08717213056053
- 08717213056077
- 08717213056091
- 08717213056398
- 08717213056411
- 08717213056435
- 08717213056459
- 08717213056473
- 08717213056497
- 08717213056510
- 08717213056534
- 08717213056558
- 08717213056572
- 08717213056596
- 08717213056619
- 08717213056633
- 08717213056657
Recall details
- Company began the recall
- Sold in
Worldwide - U.S. Nationwide distribution including in the states of Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Texas, Utah, Virginia, Wisconsin, and West Virginia. 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.
- Company
- Elekta, Inc.Atlanta, Georgia
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98704
- Recall numbers
- Z-2710-2026 to Z-2712-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
