Boston Scientific Corporation: Medical Device Recall in 2022 - (Recall #: Z-0773-2022)

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 RX 44-20-260-035 Material Number: M00573040

Product Classification:

Class II

Date Initiated: December 22, 2021

Date Posted: March 23, 2022

Recall Number: Z-0773-2022

Event ID: 89468

Reason for Recall:

Sterility of device is compromised due to a sterile barrier breach

Status: Ongoing

Product Quantity: 3578 units

Code Information:

Lot Numbers: 27465198 27515974 27595732 27625064 27720618 27737252 27765472 27833280 27883444 28002224 28296772 27491776 27595731 27618170 27718421 27758432 27764571 27830207 27858381 28002225 28289452 GTIN: 8714729776659

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