FDA
Food and Drug Administration · Recall Z-2631-2026 · May 21, 2026CRE Pro Wireguided 18-20mm 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 18-20mm 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: M00558710Model GTIN: 8714729797593Model Lot No. 38031485Model 38031486Model 38031487Model 38031488Model 38031489Model 38031490Model 38031642Model 38031643Model 38031644Model 38031645Model 38043600Model 38043601Model 38043602Model 38043603Model 38043604Model 38055580Model 38055581Model 38055582Model 38099704Model 38099705Model 38099706Model 38099707Model 38099709UPC 8714729797593Would you have heard about this one?
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