FDA DevicesClass II
CRE Wireguided 6-8mm 240cm
Published: July 8, 2026Recall ID: Z-2632-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential sterile breach of the pouches in which devices are packaged.
Product Description & Identification
CRE Wireguided 6-8mm 240cm
Additional Source Details
| Field | Value |
|---|---|
| City | Marlborough |
| State | MA |
| Event id | 99067 |
| Address 1 | 100 Boston Scientific Way |
| Address 2 | N/A |
| Code info | 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. |
| Postal code | 01752-1234 |
| Report date | 20260708 |
| Product type | Devices |
| Product quantity | 81,543 units |
| Reason for recall | Potential sterile breach of the pouches in which devices are packaged. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260521 |
| Initial firm notification | Letter |
| Center classification date | 20260701 |
Overview
- Recalling FirmBoston Scientific Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide 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.