One Step Button — Class II medical device recall Z-0402-2016
Terminated recall by Boston Scientific Corp, reported 2015-12-16, distributed in CA, CT, IN, NV, NY, PA, TN, WA…. Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, includi
| Recall number | Z-0402-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corp, Spencer, IN, United States |
| Recall initiated | 2015-09-11 |
| Classified | 2015-12-10 |
| Reported by FDA | 2015-12-16 |
| Terminated | 2016-05-17 |
| Distributed | CA, CT, IN, NV, NY, PA, TN, WA, WI |
| Countries outside the US | IE |
| Quantity | 22 units |
| Lot numbers | 18179867, 18184947, 18212410, 18296155 |
| Expiration dates | 2017-04-30, 2017-05-31, 2018-05-31 |
Product
One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
Reason for recall
Boston Scientific Corp. initiated a voluntary recall of specific lots of the EndoVive One Step Button, including the Decompression Tube and Low Profile Replacement Button devices because they may contain decompression tube adapters with a protrusion that could impede its ability to be introduced or removed from the PEG Button.
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-0402-2016. 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.