FDA
Food and Drug Administration · Recall Z-2636-2026 · May 21, 2026CRE Wireguided 15-18mm 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 15-18mm 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: M00558490Model GTIN: 8714729339427Model Lot No. 38033568Model 38033569Model 38033570Model 38033571Model 38047498Model 38047722Model 38047731Model 38200167Model 38239090Model 38325015Model 38325016Model 38325017Model 38413205Model 38413206Model 38413207Model 38413208Model 38413214Model 38422540Model 38422541Model 38422542Model 38422543Model 38479759Model 38507303UPC 8714729339427Would you have heard about this one?
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