FDA Device recall Z-2711-2026

Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced…

FDA Device
Class II
ongoing
Published 2026-07-15

On 2026-07-15 the FDA classified a Class II recall of Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced… by Elekta, citing due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2711-2026
Classification	Class II
Status	ongoing
Initiated	2026-04-03
Published	2026-07-15
Last updated	2026-09-13 11:58 UTC
Company	Elekta
Distribution	US

Product

Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.

Reason

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

Identifiers

code_info	Lot Code: 08717213055001, 08717213055018, 08717213055025, 08717213055049, 08717213055056, 08717213055063, 0871721305508… Lot Code: 08717213055001, 08717213055018, 08717213055025, 08717213055049, 08717213055056, 08717213055063, 08717213055087, 08717213055094, 08717213055100, 08717213055117, 08717213055131

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2711-2026%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.