FDA Device recall Z-1620-2018
Capio Standard Box 4 (Capio PC)
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of Capio Standard Box 4 (Capio PC) 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-1620-2018 |
| 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 Standard Box 4 (Capio PC); Model #M0068312321. 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:08714729257622 Batch numbers: 17817547 19050231 20639026 17925410 19225758 20717524 18139200 19335465 21081753…UDI:08714729257622 Batch numbers: 17817547 19050231 20639026 17925410 19225758 20717524 18139200 19335465 21081753 18363737 19437994 21258781 18615714 19698427 21386211 18826587 19983956 20341449 18955689 20341449 |
|---|
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-1620-2018%22
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