Boston Scientific recalls DREAMTOME 49-20MM/450CM devices with material number M00584020 due to sterile barrier breach. Affected units may compromise sterility during medical procedures.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling DREAMTOME 49-20MM/450CM surgical devices because a sterile barrier breach could compromise sterility during medical procedures. This means the devices might not be safe for use in surgeries if the breach occurs.
The sterile barrier in the device has been breached, which could allow contamination during medical procedures. This breach might lead to infections or other complications if the device is used without proper sterility.
Surgical device users and healthcare professionals who own or use the DREAMTOME 49-20MM/450CM model with material number M00584020. Patients undergoing surgery with these devices are at risk if sterility is compromised.
Check for the DREAMTOME 49-20MM/450CM model with material number M00584020. Lot numbers 27802363 and GTIN 8714729778240 are also associated with this recall.
Identify if your device has material number M00584020, lot number 27802363, or GTIN 8714729778240.
The recall states that sterility may be compromised due to a sterile barrier breach, so it is not safe for use in medical procedures.
The recall does not specify a remedy, so you should check with Boston Scientific for guidance on next steps.
Look for the material number M00584020, lot number 27802363, or GTIN 8714729778240 on your device.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0756-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0756-2022 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.
