The Recall Desk
SevereFDA (Devices)·Z-2710-2026·Announced 2026-07-15

Fletcher CT/MR Shielded Applicator Set for Gynecological Brachytherapy Recalled

Elekta's Fletcher CT/MR Shielded Applicator Set is recalled due to risk that the tip of the intrauterine tube may detach and remain inside a patient during gynecological brachytherapy treatment.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II medical device recall where the hazard—detachment of a component that may remain inside a patient—presents a risk of serious injury requiring medical intervention (retrieval). The potential for retained foreign material in a patient's body following a surgical procedure satisfies the "risk-of-harm" criterion for Severe severity.

Plain-English summary

Elekta, Inc. is recalling the Fletcher CT/MR Shielded Applicator Set, an intracavitary remote afterloading applicator used for gynecological brachytherapy treatment of the cervix and endometrium. The recall is due to safety concerns regarding the potential detachment of the tip of the intrauterine tube (IU tube), which may remain within a patient if detachment occurs.

The affected product (Lot Code: 08717213024205) has been distributed worldwide, including throughout the United States in multiple states and internationally across numerous countries. Healthcare facilities and treatment centers using this applicator should verify whether they have units from the affected lot.

Patients who have received or are scheduled to receive treatment with this applicator should contact their healthcare provider or treatment facility for guidance. Healthcare providers should review patient records and take appropriate action based on the potential risk of retained tube components.

The recalled product

Product
Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.
Manufacturer
Elekta, Inc.
Category
Medical Device — Gynecological Brachytherapy
Hazard
  • device-detachment
  • retained-foreign-body

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Code: 08717213024205

Distribution

Distributed nationwide across the United States.

Related recalls

Same category