Male-Female Midsection with the following sizes and model numbers — Class II medical device recall Z-1884-2025
Ongoing recall by Onkos Surgical, Inc., reported 2025-06-04, distributed in AZ, FL, GA, HI, IL, KS, KY, LA…. Potential for breach of Tyvek seals.
| Recall number | Z-1884-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Onkos Surgical, Inc., Parsippany, NJ, United States |
| Recall initiated | 2023-09-01 |
| Classified | 2025-05-29 |
| Reported by FDA | 2025-06-04 |
| Distributed | AZ, FL, GA, HI, IL, KS, KY, LA, MD, MS, NC, NE, NJ, OH, PA, TX, WA, WI |
| Quantity | 99 units |
| Lot numbers | 1802695, 1813688, 1823008, 1833874, 1841365, 1844552, 1855654, 1855799, 1856873, 1856874, 1860075, 1860076, 1880172, 1880173, 1880174, 1880175, 1880176, 1880177, 1880178, 1880179, 1880180, 1880181, 1880182, 1880183, 1880184, 1880185, 1880186, 1880187, 1880188, 1880189, 1880190, 1880191, 1880192, 1880193, 1880194, 1880195, 1880196, 1880197, 1880198, 1880199 and 59 more |
| Model numbers | 25001040E, 25001050E, 25001060E, 25001070E, 25001090E, 25001110E, 25001140E |
Product
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Number: 25001040E b. Male-Female Midsection, 50mm, 1 EACH; Model Number: 25001050E c. Male-Female Midsection, 60mm, 1 EACH; Model Number: 25001060E d. Male-Female Midsection, 70mm, 1 EACH; Model Number: e. Male-Female Midsection, 90mm, 1 EACH; Model Number: 25001090E f. Male-Female Midsection, 110mm, 1 EACH; Model Number: 25001110E g. Male-Female Midsection, 140mm, 1 EACH. Model Number: 25001140E Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM
Reason for recall
Potential for breach of Tyvek seals.
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-1884-2025. 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.