Boston Scientific Corporation: Medical Device Recall in 2022 - (Recall #: Z-0765-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

JAGTOME REVOLUTION RX 39-20-260-025 Material Number: M00584240

Product Classification:

Class II

Date Initiated: December 22, 2021

Date Posted: March 23, 2022

Recall Number: Z-0765-2022

Event ID: 89468

Reason for Recall:

Sterility of device is compromised due to a sterile barrier breach

Status: Ongoing

Product Quantity: 7115 units

Code Information:

Lot Numbers: 27481920 27524107 27525279 27530542 27574053 27598798 27652479 27722062 27722511 27742261 27758891 27795634 27846706 27897451 27969768 28027118 28070708 GTIN: 8714729953234

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, Namibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Unit. Arab Emir.

Voluntary or Mandated:

Voluntary: Firm initiated