CRE Wireguided 18-20mm 240cm medical devices recalled for sterile breach
Boston Scientific Corporation is recalling CRE Wireguided 18-20mm 240cm devices worldwide due to a potential sterile breach of the pouches in which the devices are packaged.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall. The potential sterile breach of device packaging represents a risk of harm (contamination or infection) where no reported illness or injury has been stated in the source text. Per the rubric, FDA Class II with no reported hospitalization or injury reports scores 3 (High).
Plain-English summary
Boston Scientific Corporation is recalling CRE Wireguided 18-20mm 240cm devices due to a potential sterile breach of the pouches in which these devices are packaged. The recalled devices were distributed worldwide, including nationwide in the United States and in 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, Trinidad and Tobago, Tunisia, Türkiye, United Arab Emirates, and Uruguay.
A potential breach of the sterile pouch packaging could compromise the sterile condition of the device. The affected devices have UPN M00558500, GTIN 8714729339434, and specific lot numbers ranging from 38033572 through 38886249, with expiration dates between October 24, 2028, and February 17, 2029.
Customers who have received these devices should contact Boston Scientific Corporation to determine whether their lot numbers are affected. Patients and physicians should evaluate whether to continue use of devices already implanted and discuss alternatives with their healthcare provider.
The recalled product
- Product
- CRE Wireguided 18-20mm 240cm
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Hazard
- sterile-breach
- packaging-integrity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- UPN: M00558500
- GTIN: 8714729339434
- Lot No. 38033572
- 38063250
- 38063251
- 38063252
- 38211783
- 38211784
- 38215261
- 38215262
- 38215263
- 38222236
- 38222237
- 38222238
- 38222239
- 38241879
- 38242360
- 38242361
- 38334062
- 38334063
Distribution
Distributed nationwide across the United States.
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