FDA Device recall Z-1619-2018
Capio Open Access Box 4 (Capio OPC)
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Capio Open Access Box 4 (Capio OPC) by Boston Scientific, citing potential for Capio sutures to break and /or detach.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1619-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-12 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | GA |
Product
Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open or endoscopic surgery to assist in the placement of suture material in tissues at the operative site.
Reason
Potential for Capio sutures to break and /or detach.
Identifiers
| code_info | UDI:08714729257615. Batch numbers: 17736884 18743137 19980158 17743915 18744758 20088658 17746353 18831921 2014641…UDI:08714729257615. Batch numbers: 17736884 18743137 19980158 17743915 18744758 20088658 17746353 18831921 20146415 17748695 18952185 20151917 17758603 18956329 20225741 17763024 18960345 20225743 17791930 19046994 20341445 17970678 19046996 20341447 18129693 19046998 20560166 18134147 19173285 20639024 18135271 19225756 20706637 18229178 19329479 20711254 18281817 19437996 20713128 18286295 19442739 20822293 18357019 19560316 20833214 18362244 19646043 20834317 18430411 19646222 20838382 18488288 19659042 21069563 18605754 19824767 21081751 18606004 19835267 21258659 18611631 19856248 21362105 19975069 21362107 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1619-2018%22
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