Gyrus ACMI Diego Elite Tubeset, intended for cutting… recallZ-1753-2015 · 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-1753-2015
- 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
- 22,250 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 and Neck procedures. Catalog No. TS101DC, Lot numbers JC924165 and below; Rx Only, STERILE EO
Code information (models, lots, serial numbers)
Lot Number: JC24165
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-1752-2015 · 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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