Boston Scientific Corporation recalls CRE Wireguided 12-15mm 240cm

Recalling company

Boston Scientific Corporation

Product

CRE Wireguided 12-15mm 240cm

Reason

Potential sterile breach of the pouches in which devices are packaged.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

May 21, 2026

Reported

Jul 8, 2026

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.

Status

Ongoing

Quantity

81,543 units

Lot / codes

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.

Company location

Marlborough, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-2635-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2635-2026 in the FDA Enforcement Report. Also see FDA recall press releases.