FDA
Food and Drug Administration · Recall Z-2629-2026 · May 21, 2026CRE Pro Wireguided 12-15mm 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 12-15mm 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: M00558690Model GTIN: 8714729797579Model Lot No. 38031635Model 38031636Model 38031637Model 38031638Model 38031639Model 38031640Model 38031641Model 38043114Model 38043115Model 38053614Model 38053615Model 38053616Model 38078354Model 38188253Model 38200578Model 38211780Model 38214898Model 38214899Model 38222485Model 38222487Model 38241871Model 38241872Model 38267022UPC 8714729797579Would you have heard about this one?
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