Boston Scientific recalls DREAMTOME 49-30MM/450CM devices with material number M00584030 due to sterile barrier breach risking infection. Affected units have specific lot numbers and GTIN.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling DREAMTOME 49-30MM/450CM surgical devices because a sterile barrier breach could compromise sterility. This means the devices might not be safe for use in medical procedures.
The sterile barrier in the device has been breached, which could allow contamination. This means the device might not be sterile when used in medical procedures, increasing the risk of infection.
Surgical device users and hospitals that have the DREAMTOME 49-30MM/450CM model with material number M00584030. Patients and medical staff are at risk if the device is used without proper sterility.
Check for the material number M00584030 and lot numbers 27692922 on the device. The GTIN is 8714729778257. This model was sold with these specific identifiers.
Look for the material number M00584030 and lot number 27692922 on the device.
The sterile barrier in the device has been breached, which could compromise sterility and increase infection risk during medical procedures.
Check the device for the material number M00584030 and lot number 27692922. If it matches, contact Boston Scientific for further instructions.
The recall record does not mention a remedy or fix for this issue.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0758-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0758-2022 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
