Boston Scientific recalls CRE Wireguided 8-10mm 240cm devices with potential sterile pouch breaches. Affected units have specific lot numbers and expiration dates. Consumers should contact the company for details.
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific is recalling CRE Wireguided 8-10mm 240cm devices due to potential sterile pouch breaches in packaging. This could lead to contamination during medical procedures if the device is used without proper sterilization.
The packaging pouches for these medical devices may have a breach in sterility. If the device is used without proper sterilization, it could lead to infection or contamination during medical procedures.
Medical professionals using these devices for procedures are most at risk. Patients receiving these devices during surgery may be affected if the sterile packaging is compromised.
Check for lot numbers 38064055, 38099717, 38100033, 38100034, 38164759, 38165000, 38165003, 38293337, 38293338, 38293339, 38333957, 38347335, 38347336, 38398764, 38398765, 38398766, 38529517, 38552112, 38552113, 38596880, 38680056, 38680057, 38739675. Devices expire October 27, 2028 or January 31, 2029.
Reach out to Boston Scientific for specific instructions on how to handle affected devices.
The packaging pouches for these medical devices may have a breach in sterility, potentially leading to contamination during medical procedures.
Check for lot numbers 38064055, 38099717, 38100033, 38100034, 38164759, 38165000, 38165003, 38293337, 38293338, 38293339, 38333957, 38347335, 38347336, 38398764, 38398765, 38398766, 38529517, 38552112, 38552113, 38596880, 38680056, 38680057, 38739675. Devices expire October 27, 2028 or January 31, 2029.
No, but contact Boston Scientific for specific instructions on handling affected devices.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2633-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2633-2026 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.
