TemporaryFDAOngoing
Can cause harm that is usually temporary.
CRE Pro Wireguided 15-18mm 240cm
Check the device or its packaging for
UPN: M00558700; GTIN: 8714729797586; Lot No. 38043116, 38192116, 38192117, 38192118, 38192119, 38192960, 38192961, 38214896, 38214897, 38222153, 38222496, 38222497, 38222498, 38222499, 38222660, 38222661, 38222662, 38222663, 38222664, 38222665, 38238864, 38239084, 38239085, 38239086, 38239087, 38239088, 38239089, 38241874, 38241875, 38241876, 38242679, 38242820, 38242821, 38242822, 38242824, 38269134, 38269135, 38274558, 38274559, 38282412, 38324631, 38324632, 38324633 ,38324634, 38324636, 38324637, 38324638, 38347325, 38347326, 38347327, 38347328, 38364300, 38381887, 38421906, 38421907, 38421908, 38421909, 38421910, 38421911, 38421912, 38421913, 38421914, 38441933, 38441934, 38441935, 38441936, 38450077, 38450078, 38450079, 38450260, 38450261, 38450262, 38450263, 38462131, 38462132, 38462133, 38468755, 38468756, 38472371, 38472372, 38472373, 38479757, 38479758, 38503030, 38507563, 38507564, 38507565, 38507566, 38507567, 38507568, 38507569, 38568778, 38568779, 38568860, 38585010, 38585011, 38585012, 38585013, 38621957, 38621958, 38642724, 38642725, 38642726, 38642727, 38665032, 38665033, 38665034, 38665035, 38665036, 38665038, 38678315, 38688161, 38726662, 38726663, 38726664, 38734730, 38734731, 38745591, 38748249, 38748250, 38748251, 38748253, 38762224, 38762225, 38762226, 38762227, 38762228, 38769690, 38769691, 38769692, 38800533, 38800534, 38800535, 38800536, 38831782, 38831783, 38831784, 38831785, 38831786, 38831787, 38831788, 38877007, 38877008, 38877009, 38878807, 38878808, 38878809, 38878810, 38878811, 38878812, 38886257, 38886258, 38886259, 38916782, 38916783, 38916784, 38916785, 38933957, 38933958, 38933959, 38935360, 38945672; Exp. November 24, 2028 March 26, 2029.
- Why
- Potential sterile breach of the pouches in which devices are packaged.
- Distributed
- 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.
- Company
- Boston Scientific Corporation
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2630-2026 · retrieved 1 July 2026
Read the official notice