Boston Scientific Corporation: Medical Device Recall in 2022 - (Recall #: Z-0753-2022)

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:

DREAMTOME 44-30MM/260CM Material Number: M00584050

Product Classification:

Class II

Date Initiated: December 22, 2021

Date Posted: March 23, 2022

Recall Number: Z-0753-2022

Event ID: 89468

Reason for Recall:

Sterility of device is compromised due to a sterile barrier breach

Status: Ongoing

Product Quantity: 12067 units

Code Information:

Lot Numbers: 27453804 27457431 27549729 27556712 27575367 27579180 27605386 27605881 27660096 27667092 27672343 27708191 27709633 27787771 27789167 27899695 27924755 27971482 27976277 27979230 28047306 28054381 GTIN: 8714729778271

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