Reported Mar 23, 2022 · Ongoing

JAGTOME REVOLUTION RX 39-30-260-025 Material Number: M00584260

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?

  • JAGTOME REVOLUTION
  • RX 39-30-260-025 Material NumberM00584260
Lot codes and dates
  • Lot NumbersBatch
    • 27482863
    • 27532553
    • 27602969
    • 27652583
    • 27723139
    • 27758892
    • 27796835
    • 27846707
    • 27899139
    • 27966498
    • 28021411
  • GTIN8714729953258
Amount recalled
3330 units

This recall covers 31 products

The agency filed one notice per product. You are reading one of them; the other 30 are below.

18 more are in the archive.

Where it was sold

  • Nationwide

Why it was recalled

Sterility of device is compromised due to a sterile barrier breach

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

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:51 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.