FDA
Food and Drug Administration · Recall Z-2635-2026 · May 21, 2026CRE 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 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: M00558480Model GTIN: 8714729339410Model Lot No. 38033567Model 38056239Model 38056940Model 38056941Model 38215260Model 38266854Model 38266855Model 38293330Model 38391881Model 38413876Model 38413877Model 38413878Model 38413879Model 38414080Model 38422547Model 38446204Model 38466097Model 38468862Model 38468863Model 38529518Model 38529519Model 38585004Model 38622477UPC 8714729339410Would you have heard about this one?
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