FDA
Food and Drug Administration · Recall Z-2637-2026 · May 21, 2026CRE 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 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: M00558500Model GTIN: 8714729339434Model Lot No. 38033572Model 38063250Model 38063251Model 38063252Model 38211783Model 38211784Model 38215261Model 38215262Model 38215263Model 38222236Model 38222237Model 38222238Model 38222239Model 38241879Model 38242360Model 38242361Model 38334062Model 38334063Model 38347338Model 38468864Model 38472364Model 38472365Model 38479755UPC 8714729339434Would you have heard about this one?
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