Official recall notice

FDA DeviceClass IINotable

Intracavitary Remote Afterloading Applicator Recall (Jul 2026)

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.

Recall date
2026-07-15
FDA class
Class II

Why it was recalled

Hazard

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

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Product description

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

Affected products

Lot Code: 08717213024205

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