GYRUS ACMI — Class II medical device recall Z-1439-2013
Terminated recall by Gyrus Acmi, Incorporated, reported 2013-06-12, distributed nationwide. lack of sterility assurance
| Recall number | Z-1439-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gyrus Acmi, Incorporated, Southborough, MA, United States |
| Recall initiated | 2013-05-24 |
| Classified | 2013-05-31 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2014-05-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB |
| Reason classes | sterility |
| Model numbers | 130715 |
Product
GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.
Reason for recall
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-1439-2013. 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.