Boston Scientific recalls DREAMTOME 44-30MM/260CM surgical devices with a sterile barrier breach risk. Affected units have specific lot numbers and material codes. Stop using immediately to prevent infection.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling DREAMTOME 44-30MM/260CM surgical devices because a sterile barrier breach compromises sterility. This could lead to infections if used in medical procedures.
The sterile barrier in the device has been breached, meaning it is no longer sterile. This could cause infections during medical procedures if the device is used without proper sterilization.
Surgical professionals and hospitals using the DREAMTOME 44-30MM/260CM devices with specific lot numbers. Patients undergoing surgery with these devices are at risk of infection.
Check the device label for Material Number M00584050 and Lot Numbers listed: 27453804, 27457431, 27549729, 27556712, 27575367, 27579180, 27605386, 27605881, 27660096, 27667092, 27672343, 27708191, 27709633, 27787771, 27789167, 27899695, 27924755, 27971482, 27976277, 27979230, 28047306, 28054381.
Discontinue use of the DREAMTOME 44-30MM/260CM devices with the listed lot numbers and material code to prevent infection risks.
The material number is M00584050.
Affected lot numbers include 27453804, 27457431, 27549729, 27556712, 27575367, 27579180, 27605386, 27605881, 27660096, 27667092, 27672343, 27708191, 27709633, 27787771, 27789167, 27899695, 27924755, 27971482, 27976277, 27979230, 28047306, 28054381.
Check the device label for Material Number M00584050 and Lot Numbers from the list provided in the recall notice.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0753-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0753-2022 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.
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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.
