Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Male-Female Midsection with the following sizes and model numbers. a. Recalled by Onkos Surgical, Inc. Due to Potential for breach of Tyvek seals.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Onkos Surgical, Inc. directly.
Affected Products
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
Quantity: 99 units
Why Was This Recalled?
Potential for breach of Tyvek seals.
Where Was This Sold?
This product was distributed to 18 states: AZ, FL, GA, HI, IL, KS, KY, LA, MD, MS, NE, NJ, NC, OH, PA, TX, WA, WI
About Onkos Surgical, Inc.
Onkos Surgical, Inc. has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report