Reported Jul 15, 2026 · Ongoing · Updated Sep 16, 2026
Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product…
Elekta, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Elekta, Inc. · 400 Perimeter Center Ter NE Ste 50 · Atlanta, GA · 30346-1227
Is this the product you have?
- Brand NameFletcher CT/MR
- Shielded Applicator Set Product NameIntracavitary Remote Afterloading
- Applicator Product DescriptionThe Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium
- Lot codes and dates
- Lot Code08717213024205
- Amount recalled
- 1
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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