Official recall notice
FDA DeviceClass IINotable
FDA Recall: Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading
- Recall date
- 2026-07-15
- Brand
- Elekta, Inc.
- Category
- Medical Device
- 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.
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