FDAMay 8, 2015device
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
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential lack of sterility assurance.
What to do
FDA enforcement status: Terminated
Brands named
gyrus acmigyrus
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC2019-03-08
- FDAOlympus Diego Elite Console MDCONS 1002019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB4000SS2019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4040SS2019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XS2019-03-08
- FDADiego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS2019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040XC2019-03-08
- FDADiego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB4040SC2019-03-08
Own something like this?
AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.
Start free — 200 items, no card →