Notice names this product. Boston Scientific’s CRE Wireguided 18-20mm 240cm is named in FDA Class II recall Z-2637-2026.
Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Potential sterile breach of the pouches in which devices are packaged. Identifying details: UPN: M00558500; GTIN: 8714729339434; Lot No. 38033572, 38063250, 38063251, 38063252, 38211783, 38211784, 38215261, 38215262, 38215263, 38222236, 38222237, 38222238, 38222239, 38241879, 38242360, 38242361, 38334062, 38334063, 38347338, 38468864, 38472364, 38472365, 38479755, 38596733, 38596734, 38596735, 38596736, 38596883, 38596884, 38692526, 38707831, 38709738, 38709739, 38748244, 38808896, 38874312, 38874313, 38874314, 38886248, 38886249; Exp. October 24, 2028 February 17, 2029.. Units affected: 81,543 units. Status: Ongoing.
1. Compare your item
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
- Product named
- CRE Wireguided 18-20mm 240cm
- Company / brand
- Boston Scientific
- Lot / serial / date codes
- UPN: M00558500; GTIN: 8714729339434; Lot No. 38033572, 38063250, 38063251, 38063252, 38211783, 38211784, 38215261, 38215262, 38215263, 38222236, 38222237, 38222238, 38222239, 38241879, 38242360, 38242361, 38334062, 38334063, 38347338, 38468864, 38472364, 38472365, 38479755, 38596733, 38596734, 38596735, 38596736, 38596883, 38596884, 38692526, 38707831, 38709738, 38709739, 38748244, 38808896, 38874312, 38874313, 38874314, 38886248, 38886249; Exp. October 24, 2028 February 17, 2029.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.
Agency product description and boundaries
CRE Wireguided 18-20mm 240cm
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
FDA Class II · Medical device · July 8, 2026
Potential sterile breach of the pouches in which devices are packaged.
Company / brand: Boston Scientific
Affected product: CRE Wireguided 18-20mm 240cm
Official ID Z-2637-2026 ·
Official record ↗
Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.