Reported Jul 15, 2026 · Ongoing

Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended…

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 NameBrachytherapy
  • Applicator Product NameAdvanced Gynecological
  • Applicator Product DescriptionThe intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy
Lot codes and dates
  • Lot Code
    • 08717213055001
    • 08717213055018
    • 08717213055025
    • 08717213055049
    • 08717213055056
    • 08717213055063
    • 08717213055087
    • 08717213055094
    • 08717213055100
    • 08717213055117
    • 08717213055131
Amount recalled
586

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.