FDA
Food and Drug Administration · Recall Z-2628-2026 · May 21, 2026CRE Pro Wireguided 10-12mm 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 10-12mm 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: M00558680Model GTIN: 8714729797562Model Lot No. 38031620Model 38031621Model 38031622Model 38031623Model 38031624Model 38031625Model 38031626Model 38031627Model 38031628Model 38031629Model 38031631Model 38075353Model 38078357Model 38078358Model 38078359Model 38078740Model 38078741Model 38078742Model 38078743Model 38078744Model 38078745Model 38078747Model 38100058UPC 8714729797562Would you have heard about this one?
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