OVERLOOKED

Recalls › Medicines & devices

Class IIOngoingUpdated Nov 2, 2026

Boston Scientific Corporation recalls 10 products

Recall date · record updated Jul 8, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Boston Scientific Corporation
Reason
Potential sterile breach of the pouches in which devices are packaged.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
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.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99067…

Products (10)

  1. CRE Pro Wireguided 6-8mm 240cm

    Codes/lots: UPN: 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.Quantity: 81,543 unitsRecall no. Z-2626-2026Class II

  2. CRE Pro Wireguided 8-10mm 240cm

    Codes/lots: UPN: 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, 38568Quantity: 81,543 unitsRecall no. Z-2627-2026Class II

  3. CRE Pro Wireguided 10-12mm 240cm

    Codes/lots: UPN: 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, 38398Quantity: 81,543 unitsRecall no. Z-2628-2026Class II

  4. CRE Pro Wireguided 12-15mm 240cm

    Codes/lots: 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, 38379Quantity: 81,543 unitsRecall no. Z-2629-2026Class II

  5. CRE Pro Wireguided 15-18mm 240cm

    Codes/lots: 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, 38421Quantity: 81,543 unitsRecall no. Z-2630-2026Class II

  6. CRE Wireguided 6-8mm 240cm

    Codes/lots: UPN: 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.Quantity: 81,543 unitsRecall no. Z-2632-2026Class II

  7. CRE Wireguided 8-10mm 240cm

    Codes/lots: UPN: 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.Quantity: 81,543 unitsRecall no. Z-2633-2026Class II

  8. CRE Wireguided 12-15mm 240cm

    Codes/lots: UPN: 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.Quantity: 81,543 unitsRecall no. Z-2635-2026Class II

  9. CRE Wireguided 15-18mm 240cm

    Codes/lots: UPN: 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.Quantity: 81,543 unitsRecall no. Z-2636-2026Class II

  10. CRE Wireguided 18-20mm 240cm

    Codes/lots: 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.Quantity: 81,543 unitsRecall no. Z-2637-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.
  2. Product details, codes or quantities changed; Units: 81,543 units; 81,543 units; 81,543 units; 81,543 units; 81,543 units; 81,543 units; 81,543 units; 81,543 units; 81,543 units; 81,543 units; 81,543 units; 81,543 units → 81,543 units; 81,543 units; 81,543 units; 81,543 units; 81,543 units; 81,543 units; 81,543 units; 81,543 units; 81,543 units; 81,543 units

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

More Medicines & devices recalls