PARPARELLA-TYPE VENT TUBE — Class II medical device recall Z-0411-2013
Terminated recall by Gyrus Acmi, Incorporated, reported 2012-11-28, distributed in KS. One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene v
| Recall number | Z-0411-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gyrus Acmi, Incorporated, Southborough, MA, United States |
| Recall initiated | 2012-10-17 |
| Classified | 2012-11-20 |
| Reported by FDA | 2012-11-28 |
| Terminated | 2013-04-09 |
| Distributed | KS |
| Countries outside the US | KR |
| Model numbers | 240044 |
Product
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
Reason for recall
One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
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-0411-2013. 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.