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FDAClass II · Medical device · Recalled July 8, 2026
CRE Wireguided 10-12mm 240cm recall — Boston Scientific Corporation
Hazard: Potential sterile breach of the pouches in which devices are packaged.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-2634-2026
- Brand
- Boston Scientific
- Classification
- Class II
- Units affected
- 81,543 units
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
CRE Wireguided 10-12mm 240cm
Affected products
Companies & origin
- Recalling firm location
- Marlborough, MA, United States
- Firm address
- 100 Boston Scientific Way, N/A, 01752-1234
Identifying details (verbatim from the notice)
- Product codes / lots
- UPN: 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 .
- Distribution
- 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.
- Firm notified the public via
- Letter
- FDA event ID
- 99067
- Recall initiated
- May 21, 2026
- FDA classified
- July 1, 2026
- FDA report date
- July 8, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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