Reported Jul 15, 2026 · Ongoing · Updated Sep 16, 2026
Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary…
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 NameGeneva
- Product NameBrachytherapy
- Applicator Product DescriptionThe device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial therapy
- Lot codes and dates
- Lot Code
087172130560390871721305605308717213056077087172130560910871721305639808717213056411087172130564350871721305645908717213056473087172130564970871721305651008717213056534087172130565580871721305657208717213056596087172130566190871721305663308717213056657
- Lot Code
- Amount recalled
- 1317
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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