Boston Scientific JAGTOME RX Device Recall: Sterile Barrier Breach Risk

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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 JAGTOME RX device model because a sterile barrier was compromised, which could lead to contamination. This recall affects users who have the listed lot numbers or the specific material number.

Why it’s dangerous

The sterile barrier in the device has been breached, which could allow contaminants to enter the device. This compromises the device's sterility and may lead to infections or other complications during medical procedures.

Who’s affected

Users of the JAGTOME RX 44-20-260-035 device with the listed lot numbers or material number M00573040 are affected. Medical professionals using this device for procedures are most at risk due to potential contamination.

How to tell if you have this one

Check the device's material number (M00573040) and lot numbers (27465198, 27515974, and other listed numbers). The GTIN is 8714729776659 for identification.

Brand
Boston Scientific
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Verify the material number (M00573040) and lot numbers listed in the recall notice.

✎ GovInfoNow

Questions people ask

What is the specific model number of the recalled device?

The recalled device is the JAGTOME RX 44-20-260-035 with material number M00573040.

What lot numbers are affected?

Affected lot numbers include 27465198, 27515974, 27595732, 27625064, 27720618, 27737252, 27765472, 27833280, 27883444, 28002224, 28296772, 27491776, 27595731, 27618170, 27718421, 27758432, 27764571, 27830207, 27858381, 28002225, and 28289452.

Is there a remedy for this recall?

The recall notice does not specify a remedy.

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.

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Subject: Recall Z-0773-2022 — Boston Scientific Boston Scientific

Hello,

I own a Boston Scientific that is covered by recall Z-0773-2022 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-0773-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0773-2022 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 44-20-260-035 Material Number: M00573040

Lower-risk recall