Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name:… — Class II medical device recall Z-2710-2026
Ongoing recall by Elekta, Inc., reported 2026-07-15, distributed nationwide. Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain
| Recall number | Z-2710-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Elekta, Inc., Atlanta, GA, United States |
| Recall initiated | 2026-04-03 |
| Classified | 2026-07-09 |
| Reported by FDA | 2026-07-15 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BH, BO, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, EC, EG, ES, FI, FR, GB, GR, GT, HK, HN, HR, HU, ID, IE, IN, IQ, IR, IT, JP, KE, KR, MA, MX, MY, NL, NO, NZ, PA, PE, PH, PK, PL, PT, RO, SA, SE, SG, SK, TH, TR, TW, UA, VE, VN, ZA |
| Quantity | 1 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 08717213024205 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2710-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.