Boston Scientific recalls JAGTOME RX 49-20-260-035 with sterile barrier breach. Affected units have specific lot numbers and material codes. Consumers should contact for remedy.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling a specific JAGTOME RX device model due to a sterile barrier breach that could compromise sterility. This means the device might not be safe for medical use if used without proper sterilization.
The sterile barrier breach means the device may not be properly sterilized. This could lead to infections or other complications during medical procedures if the device is used without adequate sterility checks.
Medical professionals using the JAGTOME RX 49-20-260-035 device are most at risk. Patients receiving this device could be affected if the sterility is compromised.
Check for the model number JAGTOME RX 49-20-260-035 and material number M00573000. Affected units have specific lot numbers: 27690967, 27949032, 27604634, 27692921.
Reach out to Boston Scientific for instructions on how to handle the recalled device.
The recall indicates the sterile barrier may be compromised, so it should not be used without proper verification from Boston Scientific.
Contact Boston Scientific directly for specific instructions on handling the recalled device.
Check for the model number JAGTOME RX 49-20-260-035 and material number M00573000 with the listed lot numbers.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0777-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0777-2022 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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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.
