Boston Scientific DREAMTOME 49-30MM/260CM Sterility Risk Recall

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Recalling firmBoston Scientific Corporation100 Boston Scientific Way, N/A · Marlborough, MA 01752-1234

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Boston Scientific is recalling DREAMTOME 49-30MM/260CM surgical devices because a sterile barrier breach could compromise sterility. This means the devices might not be safe for surgical use, risking infection or other complications.

Why it’s dangerous

The sterile barrier in the device can be breached, potentially allowing contamination. This could lead to infections or other complications during surgical procedures if the device is used without proper sterility.

Who’s affected

Surgical professionals and hospitals using the DREAMTOME 49-30MM/260CM devices with specific lot numbers are affected. The risk is highest for those using the devices in sterile procedures.

How to tell if you have this one

Check for the model DREAMTOME 49-30MM/260CM and lot numbers 27566790, 27641143, or 27852432. The product has a specific material number (M00584010) and GTIN 8714729778233.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for lot numbers 27566790, 27641143, or 27852432 on the device packaging or label.

✎ GovInfoNow

Questions people ask

Why is this device being recalled?

The recall is due to a potential sterile barrier breach that could compromise sterility, risking infection during surgical procedures.

What should I do if I have this device?

Check the lot number on your device. If it matches the affected numbers, contact Boston Scientific for further instructions.

Is there a fix for this issue?

The recall record does not mention a remedy or fix; affected devices should be checked and handled according to the manufacturer's guidance.

Take action

Contact Boston Scientific

We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0757-2022 — Boston Scientific Boston Scientific

Hello,

I own a Boston Scientific that is covered by recall Z-0757-2022 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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Where this comes from

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.

Official source: FDA Recall #Z-0757-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0757-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Boston Scientific Corporation recalls DREAMTOME 49-30MM/260CM Material Number: M00584010

Lower-risk recall