Onkos Surgical recalls ELEOS MALE-FEMALE MIDSECTION 40MM (Part 25001040E) due to potential assembly issues during surgery. Affected units have specific lot numbers and UDI-DI codes.
“Onkos Surgical ELEOS Midsection Recall: Assembly Challenge Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53894-onkos-surgical-eleos-midsection-recall-assembly-challenge-risk. Based on FDA recall #Z-1857-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1857-2025%22&limit=1).
Onkos Surgical, Inc. voluntarily recalled the ELEOS MALE-FEMALE MIDSECTION 40MM (Part Number: 25001040E) component of the ELEOS Limb Salvage System due to a potential assembly challenge, the FDA said on Sept. 22, 2024.
How to tell if you have it
Brand: Onkos Surgical
Product: ELEOS MALE-FEMALE MIDSECTION 40MM
Part Number: 25001040E
UDI-DI: B27825001040E0
Lot Numbers: 1989873, 1989874
Quantity: 24 units
Sold in: AZ, CA, FL, MD, MO, NC, TN
The hazard
The recall addresses a potential challenge with the intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Context
GovInfoNow's records show Onkos Surgical, Inc. has four other recalls on record since Sept. 1, 2023. Other recent recalls include an ELEOS Limb Salvage System recall for an unidentified substance hazard (July 11, 2025) and a My3D Humeral Cup recall regarding missing inspections (May 20, 2025). Similar product recalls include the Olympus HX-400U-30 Ligating Device (Oct. 30, 2025), Wilson-Cook Instinct Plus Endoscopic Clipping Device (March 3, 2026), and Medtronic Octopus 4 Tissue Stabilizer Model 29400 (May 12, 2026).
How to tell if you have this one
Check for part number 25001040E on the ELEOS MALE-FEMALE MIDSECTION 40MM. Affected units have lot numbers 1989873 or 1989874 and UDI-DI code B27825001040E0.
Brand
Onkos Surgical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for part number 25001040E, lot numbers 1989873 or 1989874, and UDI-DI code B27825001040E0 on the item.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 7 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Florida, Maryland, Missouri, North Carolina, Tennessee.
Recall timeline
FDA published this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1857-2025 (September 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1857-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.