{"url_path":"/fda/device/recalls/Z-2627-2026","section_key":"summary","section_title":"DEVICE Recall: Boston Scientific Corporation — CRE Pro Wireguided 8-10mm 240cm","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-21","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2627-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Boston Scientific Corporation"},"word_count":234,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2627-2026\n\n**Recalling firm:** Boston Scientific Corporation\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-21\n**Report date:** 2026-07-08\n\n## Product\nCRE Pro Wireguided 8-10mm 240cm\n\n## Reason\nPotential sterile breach of the pouches in which devices are packaged.\n\n## Affected lots\nUPN: M00558670; GTIN: 8714729797555; Lot No. 38031497, 38031499, 38067106, 38067107, 38067108, 38075352, 38077694, 38078752, 38078753, 38078754, 38078756, 38110982, 38131542, 38131543, 38131544, 38162876, 38169207, 38174433, 38176724, 38176725, 38176728, 38176729, 38200576, 38200577, 38212061, 38240328, 38285224, 38297438, 38297439, 38297800, 38297801, 38306683, 38306684, 38357962, 38357963, 38357964, 38357965, 38357966, 38357967, 38371552, 38381888, 38398493, 38400165, 38437963, 38468757, 38468758, 38468861, 38507306, 38507307, 38552610, 38552611, 38552612, 38552613, 38568865, 38568866, 38568867, 38579282, 38579283, 38591247, 38598328, 38598329, 38598330, 38622433, 38622434, 38622435, 38650822, 38690511, 38690512, 38697220, 38697221, 38747993, 38747994, 38770143, 38770144, 38770145, 38770146, 38770147, 38770148, 38770149, 38770150, 38886485, 38886486, 38886487, 38934882, 38958333, 38960098, 38960099, 38970337; Exp. November 23, 2028   March 30, 2029.\n\n## Distribution\nWorldwide 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."}