Recall
FDAHealthApril 3, 2026

Elekta, Inc. — Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endome

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

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
April 3, 2026

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.

What's affected?

Product
Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial therapy.
Lot code
08717213056039

Additional details

Lot Code: 08717213056039, 08717213056053, 08717213056077, 08717213056091, 08717213056398, 08717213056411, 08717213056435, 08717213056459, 08717213056473, 08717213056497, 08717213056510,08717213056534, 08717213056558, 08717213056572, 08717213056596, 08717213056619, 08717213056633, 08717213056657

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 1317.

View original FDA notice →

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