Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Gyrus ACMI Diego Elite Tubeset Recalled by Gyrus Acmi, Incorporated Due to Potential lack of sterility assurance.
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 Gyrus Acmi, Incorporated directly.
Affected Products
Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngeal/Laryngology, and Head & Neck procedures. Catalog No. TS100S, Lot numbers JC929332 and below, Rx Only, STERILE EO
Quantity: 12,020 boxes
Why Was This Recalled?
Potential lack of sterility assurance.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Gyrus Acmi, Incorporated
Gyrus Acmi, Incorporated has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report