Boston Scientific recalls CRE Wireguided 6-8mm 240cm devices with potential sterile pouch breaches. Affected units have specific lot numbers and expiration dates. Consumers should check their product details to determine if they are affected.
Potential sterile breach of the pouches in which devices are packaged.
Boston Scientific is recalling CRE Wireguided 6-8mm 240cm devices due to potential sterile breaches in the packaging pouches. This could lead to contamination of the medical device during use, posing a risk to patient safety.
The packaging pouches for these medical devices may have a breach in sterility, which could lead to contamination during use. This contamination might cause infections or other complications for patients receiving the device.
Medical professionals using these devices for procedures are most at risk. Patients receiving these devices may also be affected if the sterile packaging is compromised.
Check the product label for the lot numbers: 38064056, 38064057, 38200574, 38200575, 38204501, 38204504, 38204506, 38204508, 38628161, 38640993, 38767490, 38904960, 38904961, 38946757, 38946758, 38946759. The expiration dates are October 27, 2028 or February 24, 2029.
Review the lot numbers and expiration dates on the device packaging to determine if it is affected.
The packaging pouches may have a breach in sterility, which could lead to contamination during use.
Check the lot numbers: 38064056, 38064057, 38200574, 38200575, 38204501, 38204504, 38204506, 38204508, 38628161, 38640993, 38767490, 38904960, 38904961, 38946757, 38946758, 38946759. The expiration dates are October 27, 2028 or February 24, 2029.
The recall does not require stopping use; affected devices should be checked for lot numbers and expiration dates.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-2632-2026 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-2632-2026 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.
