Official recall notice
FDA Recall: CRE Pro Wireguided 12-15mm 240cm
- Recall date
- 2026-07-08
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Potential sterile breach of the pouches in which devices are packaged.
Product description
Potential sterile breach of the pouches in which devices are packaged.
Affected products
UPN: M00558690; GTIN: 8714729797579; Lot No. 38031635, 38031636, 38031637, 38031638, 38031639, 38031640, 38031641, 38043114, 38043115, 38053614, 38053615, 38053616, 38078354, 38188253, 38200578, 38211780, 38214898, 38214899, 38222485, 38222487, 38241871, 38241872, 38267022, 38267023, 38267024, 38267025, 38267026, 38267027, 38267028, 38269136, 38269137, 38269138, 38277754, 38277755, 38278152, 38278153, 38278154, 38285222, 38285223, 38293322, 38293324, 38293325, 38293326, 38293327, 38293328, 38293329, 38303877, 38303878, 38320463, 38346663, 38346664, 38346681, 38347329, 38378376, 38379273, 38379917, 38379918, 38379919, 38380040, 38380041, 38380042, 38383937, 38383938, 38383939, 38383980, 38383981, 38383982, 38383983, 38383984, 38398522, 38414085, 38414086, 38414087, 38414088, 38414089, 38414090, 38414091, 38414092, 38445939, 38446200, 38446201, 38446202, 38446203, 38446216, 38479982, 38479983, 38479984, 38479985, 38479986, 38507316, 38507317, 38507318, 38507319, 38507560, 38529186, 38529188, 38529189, 38529191, 38529193, 38529194, 38529195, 38529197, 38529198, 38529199, 38529380, 38529381, 38529383, 38529384, 38570828, 38570829, 38570830, 38589819, 38672653, 38672654, 38672655, 38726668, 38726669, 38726670, 38726671, 38726672, 38726673, 38726674, 38726675, 38734732, 38734733, 38734735, 38748256, 38748257, 38748258, 38748259, 38748401, 38800521, 38800522, 38800523, 38827801, 38827802, 38827803, 38827804, 38827805, 38827806, 38831789, 38831790, 38831791, 38831792, 38847493, 38847494, 38847495, 38847496, 38847497, 38847498, 38847499, 38847680, 38847681, 38878813, 38878814, 38878815, 38878816, 38878817, 38878818, 38886480, 38886481, 38916787, 38916788, 38916789, 38916790, 38933953, 38933954, 38933955, 38933956; Exp. November 23, 2028 March 25, 2029.