FDA
Food and Drug Administration · Recall Z-2627-2026 · May 21, 2026CRE Pro Wireguided 8-10mm 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 8-10mm 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: M00558670Model GTIN: 8714729797555Model Lot No. 38031497Model 38031499Model 38067106Model 38067107Model 38067108Model 38075352Model 38077694Model 38078752Model 38078753Model 38078754Model 38078756Model 38110982Model 38131542Model 38131543Model 38131544Model 38162876Model 38169207Model 38174433Model 38176724Model 38176725Model 38176728Model 38176729Model 38200576UPC 8714729797555Would you have heard about this one?
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