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Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jul 8, 2026

CRE Pro Wireguided 12-15mm 240cm

Full official product description

CRE Pro Wireguided 12-15mm 240cm | CRE Pro Wireguided 10-12mm 240cm | CRE Pro Wireguided 15-18mm 240cm | CRE Pro Wireguided 6-8mm 240cm | CRE Wireguided 8-10mm 240cm | CRE Wireguided 12-15mm 240cm | CRE Wireguided 15-18mm 240cm | CRE Wireguided 6-8mm 240cm | CRE Wireguided 18-20mm 240cm | CRE Pro Wireguided 8-10mm 240cm | CRE Wireguided 10-12mm 240cm | CRE Pro Wireguided 18-20mm 240cm

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 5, 2026, 7:44 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

CRE Pro Wireguided 12-15mm 240cm; CRE Pro Wireguided 10-12mm 240cm; plus 10 additional official variants listed below.

Identifiers to compare

  • Lot 38031635
  • Lot 38031620
  • Lot 38043116
  • Lot 38031492
  • Lot 38064055
  • Lot 38033567
  • Lot 38033568
  • Lot 38064056
  • Lot 38033572
  • Lot 38031497
  • Lot 38099718
  • Lot 38031485
  • Lot 38031636
  • Lot 38031637
  • Lot 38031638
  • Lot 38031639
  • Lot 38031640
  • Lot 38031641
  • Lot 38043114
  • Lot 38043115
  • Lot 38053614
  • Lot 38053615
  • Lot 38053616
  • Lot 38031621
  • Lot 38031622
  • Lot 38031623
  • Lot 38031624
  • Lot 38031625
  • Lot 38031626
  • Lot 38031627
  • Lot 38031628
  • Lot 38031629
  • Lot 38031631
  • Lot 38075353
  • Lot 38192116
  • Lot 38192117
  • Lot 38192118
  • Lot 38192119
  • Lot 38192960
  • Lot 38192961
  • Lot 38214896
  • Lot 38214897
  • Lot 38222153
  • Lot 38222496
  • Lot 38222497
  • Lot 38031493
  • Lot 38031494
  • Lot 38075351
  • Lot 38078758
  • Lot 38078759
  • Lot 38130599
  • Lot 38131540
  • Lot 38131541
  • Lot 38162878
  • Lot 38187284
  • Lot 38187285
  • Lot 38099717
  • Lot 38100033
  • Lot 38100034
  • Lot 38164759
  • Lot 38165000
  • Lot 38165003
  • Lot 38293337
  • Lot 38293338
  • Lot 38293339
  • Lot 38333957
  • Lot 38347335
  • Lot 38056239
  • Lot 38056940
  • Lot 38056941
  • Lot 38215260
  • Lot 38266854
  • Lot 38266855
  • Lot 38293330
  • Lot 38391881
  • Lot 38413876
  • Lot 38413877
  • Lot 38413878
  • Lot 38033569
  • Lot 38033570
  • Lot 38033571
  • Lot 38047498
  • Lot 38047722
  • Lot 38047731
  • Lot 38200167
  • Lot 38239090
  • Lot 38325015
  • Lot 38325016
  • Lot 38325017
  • Lot 38064057
  • Lot 38200574
  • Lot 38200575
  • Lot 38204501
  • Lot 38204504
  • Lot 38204506
  • Lot 38204508
  • Lot 38628161
  • Lot 38640993
  • Lot 38767490
  • Lot 38904960
  • Lot 38063250
  • Lot 38063251
  • Lot 38063252
  • Lot 38211783
  • Lot 38211784
  • Lot 38215261
  • Lot 38215262
  • Lot 38215263
  • Lot 38222236
  • Lot 38222237
  • Lot 38222238
  • Lot 38031499
  • Lot 38067106
  • Lot 38067107
  • Lot 38067108
  • Lot 38075352
  • Lot 38077694
  • Lot 38078752
  • Lot 38078753
  • Lot 38078754
  • Lot 38078756
  • Lot 38110982
  • Lot 38165001
  • Lot 38165002
  • Lot 38196568
  • Lot 38196569
  • Lot 38196570
  • Lot 38204511
  • Lot 38204512
  • Lot 38204513
  • Lot 38285933
  • Lot 38397792
  • Lot 38398767
  • Lot 38031486
  • Lot 38031487
  • Lot 38031488
  • Lot 38031489
  • Lot 38031490
  • Lot 38031642
  • Lot 38031643
  • Lot 38031644
  • Lot 38031645
  • Lot 38043600
  • Lot 38043601

12 official variants

Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
CRE Pro Wireguided 12-15mm 240cmUPN: 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, 2029.81,543 unitsZ-2629-2026
CRE Pro Wireguided 10-12mm 240cmUPN: M00558680; GTIN: 8714729797562; Lot No. 38031620, 38031621, 38031622, 38031623, 38031624, 38031625, 38031626, 38031627, 38031628, 38031629, 38031631, 38075353, 38078357, 38078358, 38078359, 38078740, 38078741, 38078742, 38078743, 38078744, 38078745, 38078747, 38100058, 38100717, 38100718, 38118422, 38118423, 38118424, 38118425, 38118426, 38118427, 38139132, 38139133, 38162877, 38164341, 38169205, 38169206, 38172338, 38176726, 38176727, 38187282, 38187283, 38193521, 38238865, 38304060, 38304061, 38304062, 38304063, 38304064, 38306688, 38334070, 38334071, 38334072, 38334073, 38383986, 38398490, 38398491, 38398492, 38402798, 38402799, 38403020, 38403021, 38421915, 38421916, 38421917, 38421918, 38421919, 38450264, 38450265, 38450266, 38450267, 38450268, 38450269, 38450270, 38468759, 38507309, 38507310, 38507311, 38507312, 38507313, 38507314, 38515209, 38515210, 38552614, 38552615, 38552616, 38552617, 38552618, 38552619, 38553520, 38553521, 38553522, 38578999, 38579280, 38579284, 38579285, 38608100, 38612264, 38612265, 38612266, 38622468, 38622469, 38622470, 38622471, 38622472, 38622473, 38650479, 38650820, 38650821, 38666087, 38668807, 38678761, 38678762, 38689027, 38689034, 38690516, 38745675, 38745676, 38769693, 38769694, 38769695, 38800516, 38800517, 38800518, 38800519, 38864609, 38864610, 38864611, 38864720, 38886482, 38886483, 38886484, 38906032, 38906033, 38906034, 38906035, 38916791, 38916792, 38933950, 38933951, 38933952, 38958793, 38959787, 38959788; Exp. November 23, 2028 March 29, 2029.81,543 unitsZ-2628-2026
CRE Pro Wireguided 15-18mm 240cmUPN: 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, 2029.81,543 unitsZ-2630-2026
CRE Pro Wireguided 6-8mm 240cmUPN: M00558660; GTIN: 8714729797548; Lot No. 38031492, 38031493, 38031494, 38075351, 38078758, 38078759, 38130599, 38131540, 38131541, 38162878, 38187284, 38187285, 38204694, 38204695, 38204696, 38380212, 38380333, 38408115, 38408116, 38408117, 38408118, 38608097, 38622221, 38642730, 38678313, 38693569, 38770151, 38770152, 38864607, 38864608, 38906029, 38933949, 38960096; Exp. November 23, 2028 March 29, 2029.81,543 unitsZ-2626-2026
CRE Wireguided 8-10mm 240cmUPN: M00558460; GTIN: 8714729339397; Lot No. 38064055, 38099717, 38100033, 38100034, 38164759, 38165000, 38165003, 38293337, 38293338, 38293339, 38333957, 38347335, 38347336, 38398764, 38398765, 38398766, 38529517, 38552112, 38552113, 38596880, 38680056, 38680057, 38739675; Exp. October 27, 2028 January 31, 2029.81,543 unitsZ-2633-2026
CRE Wireguided 12-15mm 240cmUPN: M00558480; GTIN: 8714729339410; Lot No. 38033567, 38056239, 38056940, 38056941, 38215260, 38266854, 38266855, 38293330, 38391881, 38413876, 38413877, 38413878, 38413879, 38414080, 38422547, 38446204, 38466097, 38468862, 38468863, 38529518, 38529519, 38585004, 38622477, 38622478, 38640994, 38670501, 38670502, 38670504, 38686282, 38686283, 38693725, 38726666, 38726667, 38748254, 38767487, 38789996, 38800181, 38879160, 38879163, 38879164, 38911928, 38911929, 38911930, 38944841; Exp. October 24, 2028 February 24, 2029.81,543 unitsZ-2635-2026
CRE Wireguided 15-18mm 240cmUPN: M00558490; GTIN: 8714729339427; Lot No. 38033568, 38033569, 38033570, 38033571, 38047498, 38047722, 38047731, 38200167, 38239090, 38325015, 38325016, 38325017, 38413205, 38413206, 38413207, 38413208, 38413214, 38422540, 38422541, 38422542, 38422543, 38479759, 38507303, 38507304, 38519497, 38519498, 38529540, 38529541, 38529542, 38529543, 38529544, 38585005, 38585006, 38647771, 38790079, 38817673, 38817674, 38817675, 38817676, 38817677, 38817678, 38817679; Exp. October 24, 2028 February 9, 2029.81,543 unitsZ-2636-2026
CRE Wireguided 6-8mm 240cmUPN: M00558450; GTIN: 8714729339380; Lot No. 38064056, 38064057, 38200574, 38200575, 38204501, 38204504, 38204506, 38204508, 38628161, 38640993, 38767490, 38904960, 38904961, 38946757, 38946758, 38946759; Exp. October 27, 2028 February 24, 2029.81,543 unitsZ-2632-2026
CRE Wireguided 18-20mm 240cmUPN: 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, 2029.81,543 unitsZ-2637-2026
CRE Pro Wireguided 8-10mm 240cmUPN: 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, 2029.81,543 unitsZ-2627-2026
CRE Wireguided 10-12mm 240cmUPN: M00558470; GTIN: 8714729339403; Lot No. 38099718, 38165001, 38165002, 38196568, 38196569, 38196570, 38204511, 38204512, 38204513, 38285933, 38397792, 38398767, 38398768, 38507308, 38552115, 38596881, 38596882, 38612829, 38612830, 38680058, 38683384, 38683385, 38689434, 38690171, 38707829, 38707830, 38710480, 38769697, 38800182, 38800183, 38871161, 38871162, 38871163, 38937571 ; Exp. November 2, 2028 February 23, 2029 .81,543 unitsZ-2634-2026
CRE Pro Wireguided 18-20mm 240cmUPN: M00558710; GTIN: 8714729797593; Lot No. 38031485, 38031486, 38031487, 38031488, 38031489, 38031490, 38031642, 38031643, 38031644, 38031645, 38043600, 38043601, 38043602, 38043603, 38043604, 38055580, 38055581, 38055582, 38099704, 38099705, 38099706, 38099707, 38099709, 38099710, 38099711, 38099712, 38099713, 38099714, 38099715, 38110376, 38110377, 38110378, 38110379, 38131547, 38131548, 38150880, 38150881, 38150882, 38150883, 38162872, 38162873, 38162874, 38162875, 38169202, 38169203, 3818825438188255, 38193520, 38241877, 38241878, 38258885, 38258886, 38258887, 38258888, 38258889, 38278151, 38285220, 38285221, 38306689, 38306692, 38338285, 38338288, 38338290, 38338292, 38338294, 38338296, 38338297, 38338299, 38338301, 38347330, 38462126, 38462127, 38462128, 38462129, 38479753, 38479754, 38553523, 38553524, 38553525, 38608098, 38608099, 38612875, 38612876, 38612877, 38612878, 38622479, 38622600, 38622601, 38622602, 38622603, 38642700, 38642701, 38642702, 38642722, 38650472, 38665039, 38665260, 38665261, 38665262, 38665263, 38678316, 38678317, 38678318, 38678319, 38678760, 38702327, 38702328, 38702329, 38702330, 38702331, 38702332, 38709525, 38709526, 38709527, 38709528, 38734736, 38742717, 38742718, 38745588, 38745589, 38745590, 38748246, 38748247, 38748248, 38808893, 38808894, 38808897, 38808899, 38809140, 38823455, 38823456, 38823457, 38874308, 38874309, 38874310, 38874311, 38877005, 38877006, 38886252, 38886253, 38886254, 38886255, 38946205, 38946207, 38946209, 38959786, 38964092, 38964093; Exp. November 23, 2028 March 29, 2029.81,543 unitsZ-2631-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Potential sterile breach of the pouches in which devices are packaged.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

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.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.