FDA Device recall Z-0402-2016
One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube
- FDA Device
- Class II
- terminated
- Published 2015-12-16
On 2015-12-16 the FDA classified a Class II recall of One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube by Boston Scientific, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0402-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-11 |
| Published | 2015-12-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Boston Scientific |
| Distribution | CA, CT, IN, NV, NY, PA, TN, WA, WI |
Product
One Step Button, Low Profile Initial Placement PEG Kit, gastro-enterostomy tube.
Reason
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.
Identifiers
| code_info | Material Number (UPN) M00563020, Lot # 18184947, Exp. April 30, 2017; Material Number M00563080, Lot # 18179867, Exp.…Material Number (UPN) M00563020, Lot # 18184947, Exp. April 30, 2017; Material Number M00563080, Lot # 18179867, Exp. April 30, 2017; & Lot # 18212410 , Exp. May 31, 2017; Material Number M00568510, Lot # 18296155, Exp. May 31, 2018. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0402-2016%22
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