Boston Scientific JAGTOME RX 39-30-260-025 Sterility Compromised 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 a specific model of JAGTOME RX device because a sterile barrier breach could compromise sterility, potentially leading to infections. This recall affects medical devices used in procedures requiring sterile conditions.

Why it’s dangerous

The device's sterile barrier has been breached, which means it may not be sterile when used. This could lead to infections if the device is used in procedures where sterility is critical.

Who’s affected

Medical professionals and patients using the JAGTOME RX device for procedures requiring sterile conditions. Those with the specific lot numbers or GTIN listed are most at risk.

How to tell if you have this one

Check for the model number JAGTOME RX 39-30-260-025 and material number M00573100. Affected units have specific lot numbers: 27465196, 27566099, 27603464, 27641141, 27731956, 27855806, 27998506, 28297081, or the GTIN 8714729776536.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Identify the model number and material number to confirm if your device is affected.

✎ GovInfoNow

Questions people ask

Why is this device being recalled?

The sterile barrier has been breached, which could compromise sterility and lead to infections during medical procedures.

What specific lot numbers are affected?

Lot numbers 27465196, 27566099, 27603464, 27641141, 27731956, 27855806, 27998506, and 28297081 are affected.

How can I tell if my device is recalled?

Check for the model number JAGTOME RX 39-30-260-025 and material number M00573100, or the GTIN 8714729776536.

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-0770-2022 — Boston Scientific Boston Scientific

Hello,

I own a Boston Scientific that is covered by recall Z-0770-2022 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-0770-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0770-2022 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 39-30-260-025 Material Number: M00573100

Lower-risk recall