CRE Wireguided 12-15mm 240cm recall (Boston Scientific Corporation)
Medical deviceClass IIOngoing
Summary: Boston Scientific Corporation is recalling CRE Wireguided 12-15mm 240cm. Reason: Potential sterile breach of the pouches in which devices are packaged.
What is being recalled
CRE Wireguided 12-15mm 240cm
Why
Potential sterile breach of the pouches in which devices are packaged.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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.
How to tell if yours is affected
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.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2635-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | May 21, 2026 |
| Reported | July 8, 2026 |
| Company | Boston Scientific Corporation |
| Company location | Marlborough, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 81,543 units |
More recalls from Boston Scientific Corporation · all medical device recalls · recalls from May 2026