Boston Scientific recalls CRE Pro Wireguided 10-12mm 240cm catheters due to potential sterile breach in packaging. Affected units have specific lot numbers and expiration dates. Consumers should check their packaging for the lot numbers listed.
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific is recalling certain CRE Pro Wireguided 10-12mm 240cm catheters because the packaging pouches might not be sterile. This could lead to infections if the catheters are used without proper sterility.
The packaging pouches for the catheters may not be sterile, which could lead to infections if the catheters are used without proper sterilization. This is a potential risk during medical procedures.
People who own or use the recalled CRE Pro Wireguided catheters for medical procedures. Patients undergoing procedures requiring these catheters are most at risk.
Check the packaging for the lot numbers listed: 38031620 through 38959788. The expiration dates are November 23, 2028, and March 29, 2029.
Look for the lot numbers on the packaging: 38031620 through 38959788, with expiration dates of November 23, 2028, or March 29, 2029.
The recalled model is Boston Scientific CRE Pro Wireguided 10-12mm 240cm.
Check the packaging for lot numbers between 38031620 and 38959788, with expiration dates of November 23, 2028, or March 29, 2029.
The recall does not specify a remedy, so no action is required beyond checking if your catheter is affected.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2628-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2628-2026 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.
