Recall archive / 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. Source coverage and dates.
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
What the recall classes mean. 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.
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.