Boston Scientific HYDRATOME RX 44-20MM/260CM Sterility Risk Recall

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Contact the company & request your remedy

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

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Boston Scientific is recalling HYDRATOME RX 44-20MM/260CM surgical devices because a sterile barrier breach could compromise sterility. This risk means the devices might become contaminated during use, potentially causing infections.

Why it’s dangerous

The sterile barrier in the device can be breached, leading to contamination. This could cause infections if the device is used in medical procedures without proper sterility.

Who’s affected

Surgical professionals and hospitals using the HYDRATOME RX 44-20MM/260CM devices with specific lot numbers. The risk is low for most users as the devices are used in controlled medical settings.

How to tell if you have this one

Check the lot numbers: 27439836, 27440919, 27493069, 27496980, 27499896, 27750785, 27753215, 27825981, 27879216, 27880741, 27931764, 27934862, 28032489, 28043447. The product is sold under Material Number M00583040.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Lot Number
Look for the lot numbers listed: 27439836, 27440919, 27493069, 27496980, 27499896, 27750785, 27753215, 27825981, 27879216, 27880741, 27931764, 27934862, 28032489, 28043447.

✎ GovInfoNow

Questions people ask

What is the risk of using this device?

The sterile barrier can be breached, potentially causing contamination and infection during medical procedures.

How can I check if my device is affected?

Check the lot numbers: 27439836, 27440919, 27493069, 27496980, 27499896, 27750785, 27753215, 27825981, 27879216, 27880741, 27931764, 27934862, 28032489, 28043447.

Do I need to return the device?

The recall record does not specify a return or replacement action.

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-0759-2022 — Boston Scientific Boston Scientific

Hello,

I own a Boston Scientific that is covered by recall Z-0759-2022 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-0759-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0759-2022 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 HYDRATOME RX 44-20MM/260CM Material Number: M00583040

Lower-risk recall