Reported May 16, 2018 · Terminated

Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the…

Boston Scientific Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234

Is this the product you have?

  • Capio RP; Model #M0068321010. Intended for use in general suturing applications during open surgery to assist in the placement of suture material in tissues at the operative site.
Lot codes and dates
  • UDI08714729470212
  • Batch numbers
    • 17813516
    • 18653139
    • 19987270
    • 18014753
    • 18886132
    • 20278129
    • 18015797
    • 19173287
    • 20604455
    • 18015964
    • 19335466
    • 20844362
    • 18234939
    • 19491590
    • 21178815
    • 18237323
    • 19693866
    • 21227473
    • 21386746
Amount recalled
2,567

This recall covers 11 products

The agency filed one notice per product. You are reading one of them; the other 10 are below.

Where it was sold

Why it was recalled

Potential for Capio sutures to break and /or detach.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 10, 2020 · Data as of Sep 19, 4:54 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.