FDA
Food and Drug Administration · Recall Z-2634-2026 · May 21, 2026CRE Wireguided 10-12mm 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 Wireguided 10-12mm 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: M00558470Model GTIN: 8714729339403Model Lot No. 38099718Model 38165001Model 38165002Model 38196568Model 38196569Model 38196570Model 38204511Model 38204512Model 38204513Model 38285933Model 38397792Model 38398767Model 38398768Model 38507308Model 38552115Model 38596881Model 38596882Model 38612829Model 38612830Model 38680058Model 38683384Model 38683385Model 38689434UPC 8714729339403Would 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.