Official recall notice

FDA DeviceClass IINotable

FDA Recall: Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Descr

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.

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: 08717213055001, 08717213055018, 08717213055025, 08717213055049, 08717213055056, 08717213055063, 08717213055087, 08717213055094, 08717213055100, 08717213055117, 08717213055131

Verify with the official notice →
Share:

Related Recalls

2026-07-15 · FDA_DEVICE
FDA Recall: Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading
Elekta, Inc.
2026-07-15 · FDA_DEVICE
FDA Recall: Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is inten
Elekta, Inc.
2026-06-17 · FDA_DEVICE
FDA Recall: MOSAIQ Oncology Information System
Elekta, Inc.
2026-05-06 · FDA_DEVICE
FDA Recall: Brand Name: Leksell Vantage Arc System REF: 1053958
Elekta, Inc.