Boston Scientific recalls JAGTOME REVOLUTION RX 39-30-260-025 with sterile barrier breach risk. Affected units have specific lot numbers and material codes. Contact for remedy.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling a specific model of surgical device due to a potential breach in its sterile barrier. This could compromise the device's sterility, risking infection during medical procedures.
The device's sterile barrier may have been breached, leading to contamination. This could cause infections during medical procedures if the device is not properly sterile.
Surgical device users and healthcare providers who own the recalled JAGTOME REVOLUTION RX model with specific lot numbers. Patients using this device are at risk of infection if the sterility is compromised.
Check for the model number JAGTOME REVOLUTION RX 39-30-260-025 and lot numbers listed: 27482863, 27532553, 27602969, 27652583, 27723139, 27758892, 27796835, 27846707, 27899139, 27966498, 28021411.
Identify the model number JAGTOME REVOLUTION RX 39-30-260-025 on the device.
Confirm if your device has one of the listed lot numbers: 27482863, 27532553, 27602969, 27652583, 27723139, 27758892, 27796835, 27846707, 27899139, 27966498, 28021411.
The recall states the sterile barrier may be compromised, so it is not safe for use without verification.
Check for the model number JAGTOME REVOLUTION RX 39-30-260-025 and one of the listed lot numbers.
The recall does not specify a remedy, so contact Boston Scientific for guidance.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0767-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0767-2022 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.
