--- title: "Male-Female Midsection with the following sizes and model numbers. a. Male-Fe... — FDA record Z-1884-2025 | Is It on Recall" description: "Potential for breach of Tyvek seals." url: https://isitonrecall.com/recall/fda-device-z-1884-2025-male-female-midsection-with-the-following-sizes-and-model-numbers-a-male-female-midsection-40mm-1-ea/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model Num... — FDA record Z-1884-2025 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Sep 1, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **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. - **Classification**: Class II - **Recalling firm**: Onkos Surgical, Inc. - **Quantity**: 99 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-1884-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1884-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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 Number: 25001110E; UDI-DI: B27825001110E0; Lot Numbers: 1880233, 1880234, 1880235, 1880236, 1880237, 1880238, 1880239, 1880240, 1880241, 1880242, 1880243, 1880244, 1880245. g. Model Number: 25001140E; UDI-DI: B27825001140E0; Lot Numbers: 1880246, 1880247, 1880248, 1880249, 1880250, 1880251, 1880252, 1880253, 1880254, 1880255, 1880256, 1880257, 1880258. | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Product was shipped from Onkos' distribution in Olive Branch, MS to consignees in the following states: GA, TX, WA, LA, NJ, FL, AZ, MD, MS, KS, IL, WI, KY, PA, NC, NE, OH, HI. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Arizona](https://isitonrecall.com/state/arizona/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Texas](https://isitonrecall.com/state/texas/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) ## Dates in the source - **Report date**: Jun 4, 2025 - **Recall initiation date**: Sep 1, 2023 - **Center classification date**: May 29, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1884-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Onkos Surgical, Inc. records](https://isitonrecall.com/brand/onkos-surgical-inc/)