CLASS II ONGOING Device recall · Reported 15 Jul 2026 · FDA Enforcement Report

Fletcher CT/MR Shielded Applicator Set Intracavitary Remote recalled

Elekta is recalling Fletcher CT/MR Shielded Applicator Set Intracavitary Remote Afterloading Applicator, distributed nationwide in the US. The recall was initiated on 3 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Code: 08717213024205

Quantity recalled1

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2710-2026
FDA event ID: 98704
Recalling firm: Elekta, Atlanta, GA
Classification: Class II
Status: Ongoing
Recall initiated: 3 Apr 2026
FDA classified: 9 Jul 2026
Reported: 15 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

3 Apr 2026	Recall initiated by company
9 Jul 2026	Classified by FDA	+97 days
15 Jul 2026	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Arkansas Arizona California Colorado Connecticut District of Columbia Florida Georgia Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Missouri Mississippi North Carolina

Questions about this recall

Is Fletcher CT/MR Shielded Applicator Set Intracavitary Remote Afterloading Applicator recalled?

Yes. Elekta recalled Fletcher CT/MR Shielded Applicator Set Intracavitary Remote Afterloading Applicator on 3 Apr 2026. The recall is Class II and its status is Ongoing. Recall number Z-2710-2026.

Why was it recalled?

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

Which lots are affected?

Lot Code: 08717213024205

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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