Elekta Fletcher CT/MR Shielded Applicator Set Recall
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Elekta, Inc. is recalling the Fletcher CT/MR Shielded Applicator Set due to potential detachment of the intrauterine tube tip that may remain in a patient.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 9, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
What Happened
Elekta, Inc. initiated a voluntary recall of the Fletcher CT/MR Shielded Applicator Set due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
Which Products Are Affected
The affected product is the Fletcher CT/MR Shielded Applicator Set (Intracavitary Remote Afterloading Applicator), intended for gynecological brachytherapy treatment of the cervix and endometrium. One unit is affected under Lot Code 08717213024205. The recall number is Z-2710-2026. Distribution includes U.S. nationwide (states: 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, WV) and 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.
What You Should Do
The recalling firm is Elekta, Inc., located at 400 Perimeter Center Ter NE Ste 50, Atlanta, GA 30346-1227. Consumers should refer to the firm's notification for further guidance on the recall.
Why This Matters
This Class II recall addresses a device defect with potential to cause temporary or reversible adverse health consequences during gynecological brachytherapy procedures.
Source
FDA recall Z-2710-2026 (event ID 98704). https://www.fda.gov
Original source: FDA Official Notice ↗
Related FDA Recalls
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Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,998 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.