FDA
Food and Drug Administration · Recall Z-2626-2026 · May 21, 2026CRE Pro Wireguided 6-8mm 240cm
Boston Scientific Corporation
The hazard
Potential sterile breach of the pouches in which devices are packaged. FDA Class II recall.
The remedy
Follow FDA guidance
About this recall
CRE Pro Wireguided 6-8mm 240cm
Affected identifiers
Check these against the label on your unit. An identifier match is how a recall is confirmed, not just suspected.
Model UPN: M00558660Model GTIN: 8714729797548Model Lot No. 38031492Model 38031493Model 38031494Model 38075351Model 38078758Model 38078759Model 38130599Model 38131540Model 38131541Model 38162878Model 38187284Model 38187285Model 38204694Model 38204695Model 38204696Model 38380212Model 38380333Model 38408115Model 38408116Model 38408117Model 38408118Model 38608097Model 38622221UPC 8714729797548Would you have heard about this one?
RapidRecall watches everything you own against every new federal recall and emails you the moment something you bought turns up. Free for your most important items.
Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.