Boston Scientific Corporation: Medical Device Recall in 2022 - (Recall #: Z-0764-2022)

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:

HYDRATOME RX 49-30MM/260CM Material Number: M00583010

Product Classification:

Class II

Date Initiated: December 22, 2021

Date Posted: March 23, 2022

Recall Number: Z-0764-2022

Event ID: 89468

Reason for Recall:

Sterility of device is compromised due to a sterile barrier breach

Status: Ongoing

Product Quantity: N/A

Code Information:

Lot Numbers: 27641142 28045346 GTIN: 8714729755166

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