Gyrus ACMI Diego Elite Tubeset recallZ-1752-2015 · Gyrus Acmi, Incorporated · initiated May 8, 2015
Class II Terminated All recalls posted in June 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Gyrus Acmi, Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential lack of sterility assurance.
FDA root cause category: Under Investigation by firm
What the company is doing
The firm notified their direct accounts of the recall by Fed Ex Second Day on 05/08/2015. The letter requesting disposal of the product was extended to hospitals or medical practices that purchased the product. Non-responding consignees will be contacted again if necessary.
Recall details
- Recall number
- Z-1752-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 8, 2015
- Posted by the FDA
- Jun 11, 2015
- Recalling firm
- Gyrus Acmi, Incorporated
- Quantity
- 12,020 boxes
- Product code
- GEI
- FDA submissions
- K123429
- Distribution
- Nationwide and Canada, Australia, Germany, New Zealand, Japan, India, Great Britain
Product description
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
Code information (models, lots, serial numbers)
Lot number: JC929332
Other devices under the same FDA submission
8 devices cleared under K123429 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- DIEGO ELITE MDCONS100Gyrus ACMI, LLC · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES26 reports
- DIEGO ELITE MDHP100AGyrus ACMI, LLC · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES16 reports
- DIEGO ELITE MDFS100Gyrus ACMI, LLC · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES6 reports
- DIEGO ELITE MDHP100SGyrus ACMI, LLC · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES5 reports
- DIEGO ELITE TS101DCGyrus ACMI, LLC · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES5 reports
- DIEGO ELITE BB2000SAGyrus ACMI, LLC · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- DIEGO ELITE BB4040SSGyrus ACMI, LLC · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
- Diego Elite NCGRIPGyrus ACMI, LLC · ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 71238).
- Z-1753-2015 · TerminatedGyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus/Rhinology, Nasopharyngea…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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