Boston Scientific HYDRATOME RX 44-30MM/450CM Sterility Risk Recall

Take action

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 44-30MM/450CM surgical devices because a sterile barrier breach could compromise sterility. This risk could lead to infections if the device is used without proper sterilization.

Why it’s dangerous

The device has a sterile barrier that can be breached, potentially allowing contaminants to enter the device. This could compromise sterility during medical procedures, increasing infection risk.

Who’s affected

Surgical professionals and hospitals using the HYDRATOME RX 44-30MM/450CM device with material number M00583070 are affected. Those handling the device during procedures are at the highest risk.

How to tell if you have this one

Check for the material number M00583070 on the device. Affected units include specific lot numbers: Batch 27556713, 27684748, and 27949033.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Look for the material number M00583070 and specific lot numbers on the device.

✎ GovInfoNow

Questions people ask

Why is this device being recalled?

The sterile barrier in the device can be breached, potentially compromising sterility during medical procedures.

What should I do if I have this device?

Check the device for the material number M00583070 and specific lot numbers. If affected, contact Boston Scientific for further instructions.

Is there a risk of serious injury?

The recall addresses sterility risks, not direct injury. Infections are the primary concern, not physical harm.

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-0762-2022 — Boston Scientific Boston Scientific

Hello,

I own a Boston Scientific that is covered by recall Z-0762-2022 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.

Similar recalls

From people who’ve dealt with this

Experiences, tips, and questions from readers. Every comment is reviewed before it appears.

No comments yet — be the first to share your experience.

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-0762-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0762-2022 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 44-30MM/450CM Material Number: M00583070

Lower-risk recall