Boston Scientific JAGTOME RX 44-30-4: Sterile barrier breach risks infection

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 a specific JAGTOME RX device model due to a sterile barrier breach that could compromise sterility during medical procedures. This means the device might not be sterile when used, increasing infection risk for patients.

Why it’s dangerous

The sterile barrier in the device has been breached, meaning the device may not be sterile when used. This could lead to infections during medical procedures if the device is not properly sterilized before use.

Who’s affected

Healthcare professionals using this device for medical procedures are most at risk. Patients receiving procedures with this device could face infection risks.

How to tell if you have this one

Check for the model number JAGTOME RX 44-30-450-035 and material number M00573070. Affected units have specific lot numbers: Batch 27737251, 27970819, 28289451, 27821545, or 28019275.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for the model number JAGTOME RX 44-30-450-035 and material number M00573070 on the device.

✎ GovInfoNow

Questions people ask

Is this device safe to use?

The device may not be sterile due to a sterile barrier breach, so it should not be used without proper sterilization.

What lot numbers are affected?

Affected lot numbers are Batch 27737251, 27970819, 28289451, 27821545, and 28019275.

How can I get a replacement?

The recall record does not specify a remedy or replacement process.

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-0776-2022 — Boston Scientific Boston Scientific

Hello,

I own a Boston Scientific that is covered by recall Z-0776-2022 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-0776-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0776-2022 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 JAGTOME RX 44-30-450-035 Material Number: M00573070

Lower-risk recall