FDA
Food and Drug Administration · Recall Z-2633-2026 · May 21, 2026CRE Wireguided 8-10mm 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 8-10mm 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: M00558460Model GTIN: 8714729339397Model Lot No. 38064055Model 38099717Model 38100033Model 38100034Model 38164759Model 38165000Model 38165003Model 38293337Model 38293338Model 38293339Model 38333957Model 38347335Model 38347336Model 38398764Model 38398765Model 38398766Model 38529517Model 38552112Model 38552113Model 38596880Model 38680056Model 38680057Model 38739675UPC 8714729339397Would 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.