FDA Device recall Z-1884-2025
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH
- FDA Device
- Class II
- ongoing
- Published 2025-06-04
On 2025-06-04 the FDA classified a Class II recall of Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH by Onkos Surgical, citing potential for breach of Tyvek seals.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1884-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-01 |
| Published | 2025-06-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Onkos Surgical |
| Distribution | AZ, FL, GA, HI, IL, KS, KY, LA, MD, MS, NC, NE, NJ, OH, PA, TX, WA, WI |
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
Potential for breach of Tyvek seals.
Identifiers
| code_info | a. Model Number: 25001040E; UDI-DI: B27825001040E0; Lot Numbers: 1802695, 1813688, 1823008, 1833874, 1841365, 1844552,…a. Model Number: 25001040E; UDI-DI: B27825001040E0; 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. b. Model Number: 25001050E; UDI-DI: B27825001050E0; Lot Numbers: 1880183, 1880184, 1880185, 1880186, 1880187, 1880188, 1880189, 1880190, 1880191, 1880192, 1880193, 1880194, 1880195, 1880196. c. Model Number: 25001060E; UDI-DI: B27825001060E0; Lot Numbers: 1880197, 1880198, 1880199, 1880200, 1880201, 1880202, 1880203, 1880204, 1880205. d. Model Number: 25001070E; UDI-DI: B27825001070E0; Lot Numbers: 1880206, 1880207, 1880208, 1880209, 1880210, 1880211, 1880212, 1880213, 1880214, 1880215, 1880216, 1880217. e. Model Number: 25001090E; UDI-DI: B27825001090E0; Lot Numbers: 1880218, 1880219, 1880220, 1880221, 1880222, 1880223, 1880224, 1880225, 1880226, 1880227, 1880228, 1880229, 1880230, 1880231, 1880232. f. Model Numb |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1884-2025%22
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