Reported Jun 4, 2025 · Ongoing
Male-Female Midsection with the following sizes and model numbers. a. Male-Female Midsection, 40mm, 1 EACH; Model…
Onkos Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Onkos Surgical, Inc. · 77 E Halsey Rd · Parsippany, NJ · 07054-3714
Is this the product you have?
7 of 7 products
| Model / number | Product as published |
|---|---|
25001040E | Male-Female Midsection, 40mm, 1 EACH |
25001050E | Male-Female Midsection, 50mm, 1 EACH |
25001060E | Male-Female Midsection, 60mm, 1 EACH |
| — | Male-Female Midsection, 70mm, 1 EACH; Model Number |
25001090E | Male-Female Midsection, 90mm, 1 EACH |
25001110E | Male-Female Midsection, 110mm, 1 EACH |
25001140E | Male-Female Midsection, 140mm, 1 EACH. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM |
- Amount recalled
- 99 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
Potential for breach of Tyvek seals.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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