Boston Scientific Capio OPC Sutures May Break During Surgery

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Contact the company & request your remedy

Recalling firmBoston Scientific Corporation100 Boston Scientific Way, N/A · Marlborough, MA 01752-1234

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Boston Scientific is recalling Capio Open Access Box 4 sutures (model #M0068311251) because they may break or detach during surgery. This could lead to complications if the sutures fail while being used in open or endoscopic procedures.

Why it’s dangerous

The sutures could break or detach while being used in open or endoscopic surgery. This might cause the suture material to become loose in tissues, potentially leading to complications during the procedure.

Who’s affected

Surgical teams and medical professionals who use the Capio Open Access Box 4 sutures for open or endoscopic procedures are most at risk. Patients undergoing surgery with these sutures may face complications if the sutures break during the procedure.

How to tell if you have this one

Check for the model number M0068311251 on the Capio Open Access Box 4 (Capio OPC) suture packaging. Affected units have specific batch numbers listed in the recall notice, ranging from 2014 to 2023.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Suture Packaging
Look for the model number M0068311251 on the Capio Open Access Box 4 suture packaging.
Contact Manufacturer
Reach out to Boston Scientific Corporation for guidance on next steps if you have the affected suture model.

✎ GovInfoNow

Questions people ask

What is the model number for the recalled sutures?

The model number is M0068311251 for the Capio Open Access Box 4 (Capio OPC).

What batch numbers are affected?

Affected batch numbers range from 17736884 to 21362107, as listed in the recall notice.

How can I tell if I have the recalled suture?

Check the suture packaging for model number M0068311251 and verify the batch number against the list provided in the recall.

Take action

Contact Boston Scientific

We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1619-2018 — Boston Scientific Boston Scientific

Hello,

I own a Boston Scientific that is covered by recall Z-1619-2018 from Boston Scientific.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1619-2018 (February 12, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1619-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 28, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Boston Scientific Corporation recalls Capio Open Access Box 4 (Capio OPC); Model #M0068311251. Intended for use in general suturing applications during open

Use caution until it’s fixed