Boston Scientific JAGTOME RX 44-20-450-035 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 during medical procedures if the device is not properly sterilized before use.

Who’s affected

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

How to tell if you have this one

Check for the model number JAGTOME RX 44-20-450-035 and material number M00573050. Affected units have specific lot numbers: 27535120, 27643043, 27730949, 27836207, 27571950, 27591704, 27625065, 27773387.

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 code to confirm if your device is affected.

✎ GovInfoNow

Questions people ask

What is the specific model number of the recalled device?

The recalled device is JAGTOME RX 44-20-450-035 with material number M00573050.

What lot numbers are affected?

Affected lot numbers are 27535120, 27643043, 27730949, 27836207, 27571950, 27591704, 27625065, and 27773387.

How can I confirm if my device is recalled?

Check for the model number JAGTOME RX 44-20-450-035 and material number M00573050, and verify the lot number is in the list provided.

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-0774-2022 — Boston Scientific Boston Scientific

Hello,

I own a Boston Scientific that is covered by recall Z-0774-2022 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-0774-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0774-2022 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 44-20-450-035 Material Number: M00573050

Lower-risk recall