Boston Scientific JAGTOME RX 39-20-260-025 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 a specific model of JAGTOME RX device because a sterile barrier breach could compromise sterility. This means the device might not be safe for medical use if it's been used after the breach.

Why it’s dangerous

The device has a sterile barrier that could be compromised, meaning it might not be sterile when used. This could lead to infections or other complications if the device is used in medical procedures without proper sterility.

Who’s affected

Medical professionals who use this device for procedures are likely affected. Patients using the device could be at risk if the sterility breach occurs during use.

How to tell if you have this one

Check for the model number JAGTOME RX 39-20-260-025 and material number M00573080. Affected units have specific lot numbers: 27505913, 27563424, 27629942, 27731957, 27755861, 27839657, 27846391, 27986551, 27991931, 28036372.

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 39-20-260-025 and material number M00573080 on the device.
Contact Manufacturer
Reach out to Boston Scientific Corporation for further instructions if you have the affected model.

✎ GovInfoNow

Questions people ask

Is this device safe to use?

The device may not be sterile due to a barrier breach, so it should not be used in medical procedures without proper verification.

What lot numbers are affected?

Affected lot numbers are 27505913, 27563424, 27629942, 27731957, 27755861, 27839657, 27846391, 27986551, 27991931, and 28036372.

How can I get a replacement?

Boston Scientific Corporation has not provided a replacement option in this recall notice.

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-0768-2022 — Boston Scientific Boston Scientific

Hello,

I own a Boston Scientific that is covered by recall Z-0768-2022 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-0768-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0768-2022 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 39-20-260-025 Material Number: M00573080

Lower-risk recall