FDA
Food and Drug Administration · Recall Z-2632-2026 · May 21, 2026CRE Wireguided 6-8mm 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 6-8mm 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: M00558450Model GTIN: 8714729339380Model Lot No. 38064056Model 38064057Model 38200574Model 38200575Model 38204501Model 38204504Model 38204506Model 38204508Model 38628161Model 38640993Model 38767490Model 38904960Model 38904961Model 38946757Model 38946758Model 38946759Model Exp. October 27Model 2028 February 24Model 2029.UPC 8714729339380Would you have heard about this one?
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Start monitoring freeSourced from the Food and Drug Administration’s public recall data. Always verify serial and date ranges against the official notice before acting.