Boston Scientific recalls HYDRATOME RX 44-30MM/260CM surgical devices with a sterile barrier breach. This compromises sterility and may lead to infections during procedures. Affected units have specific lot numbers and material codes.
Sterility of device is compromised due to a sterile barrier breach
Boston Scientific is recalling HYDRATOME RX 44-30MM/260CM surgical devices because a sterile barrier breach could compromise sterility. This risk means the devices might cause infections during medical procedures if used without proper sterilization.
The sterile barrier breach means the device may not be properly sterilized. This could lead to contamination during medical procedures, increasing the risk of infections for patients.
Healthcare professionals using these devices for medical procedures are most at risk. Patients receiving surgery with affected devices could face infection risks.
Check for the material number M00583050 and lot numbers 27503545, 27539248, 27622371, 27830206, 27836999, 27892995, or 27940790. The GTIN is 8714729755203.
Verify the material number and lot numbers listed in the recall notice to confirm if your device is affected.
The sterile barrier breach could compromise sterility, increasing the risk of infection during medical procedures.
Check the material number and lot numbers to see if your device is affected. If it is, contact Boston Scientific for further instructions.
Look for the material number M00583050 and lot numbers 27503545, 27539248, 27622371, 27830206, 27836999, 27892995, or 27940790.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-0761-2022 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-0761-2022 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.
