Drug recall
Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The…
FDA recall event 98704 · Class II · Elekta, Inc.
Key facts
| Event ID | 98704 |
|---|---|
| Recall numbers | Z-2710-2026, Z-2711-2026, Z-2712-2026 |
| Recalling firm | Elekta, Inc. |
| Product type | Devices |
| Products | Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for…, 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…, Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. |
| Initiation date | Apr 3, 2026 |
| Report date | Jul 15, 2026 |
| City | Atlanta |
| State | GA |
| Country | United States |
| FEI number | 1037831 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: