Gyrus ACMI Diego Elite Tubeset — Class II medical device recall Z-1752-2015
Terminated recall by Gyrus Acmi, Incorporated, reported 2015-06-17, distributed nationwide. Potential lack of sterility assurance.
| Recall number | Z-1752-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gyrus Acmi, Incorporated, Southborough, MA, United States |
| Recall initiated | 2015-05-08 |
| Classified | 2015-06-11 |
| Reported by FDA | 2015-06-17 |
| Terminated | 2016-05-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, DE, GB, IN, JP, NZ |
| Quantity | 12,020 boxes |
| Reason classes | sterility |
| Lot numbers | JC929332 |
| Model numbers | TS100S |
Product
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
Reason for recall
Potential lack of sterility assurance.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1752-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.