FDA
Food and Drug Administration · Recall Z-2630-2026 · May 21, 2026CRE Pro 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 Pro 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: M00558700Model GTIN: 8714729797586Model Lot No. 38043116Model 38192116Model 38192117Model 38192118Model 38192119Model 38192960Model 38192961Model 38214896Model 38214897Model 38222153Model 38222496Model 38222497Model 38222498Model 38222499Model 38222660Model 38222661Model 38222662Model 38222663Model 38222664Model 38222665Model 38238864Model 38239084Model 38239085UPC 8714729797586Would you have heard about this one?
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