Z-2629-2026Class II
CRE Pro Wireguided 12-15mm 240cm
Boston Scientific Corporation / initiated 2026-05-21 / Open, Classified / root cause: packaging
Boston Scientific Corporation began a recall of CRE Pro Wireguided 12-15mm 240cm on . FDA classified it as Class II and gives the reason as "Potential sterile breach of the pouches in which devices are packaged". As of , the recall status on record is Open, Classified, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-2629-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Boston Scientific Corporation
- Product
- CRE Pro Wireguided 12-15mm 240cm
- Product code
- FGE Stents, Drains And Dilators For The Biliary Ducts
- Reason for recall
- Potential sterile breach of the pouches in which devices are packaged.
- Root cause tag
- packaging
- FDA root cause
- Package design/selection
- Action
- An Urgent Medical Device Removal - Immediate Action Required notification was mailed to consignees on 5/21/26. This notification informed consignees that Boston Scientific was conducting a removal of affected devices due to a potential sterile breach of product packaging (pouches). Consignees are instructed to immediately stop further use or distribution of product and quarantine them. Consignees are to complete and return the provided Reply Verification Tracking Form and return the product to Boston Scientific per the provided instructions. Consignees are to share the recall notification with any healthcare provider that uses the affected devices and with organizations to which product was further distributed. Consignees with any questions are to contact their Boston Scientific representative.
- Quantity in commerce
- 81,543 units
- 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.
- Product codes and lots
- UPN: M00558690; GTIN: 8714729797579; Lot No. 38031635, 38031636, 38031637, 38031638, 38031639, 38031640, 38031641, 38043114, 38043115, 38053614, 38053615, 38053616, 38078354, 38188253, 38200578, 38211780, 38214898, 38214899, 38222485, 38222487, 38241871, 38241872, 38267022, 38267023, 38267024, 38267025, 38267026, 38267027, 38267028, 38269136, 38269137, 38269138, 38277754, 38277755, 38278152, 38278153, 38278154, 38285222, 38285223, 38293322, 38293324, 38293325, 38293326, 38293327, 38293328, 38293329, 38303877, 38303878, 38320463, 38346663, 38346664, 38346681, 38347329, 38378376, 38379273, 38379917, 38379918, 38379919, 38380040, 38380041, 38380042, 38383937, 38383938, 38383939, 38383980, 38383981, 38383982, 38383983, 38383984, 38398522, 38414085, 38414086, 38414087, 38414088, 38414089, 38414090, 38414091, 38414092, 38445939, 38446200, 38446201, 38446202, 38446203, 38446216, 38479982, 38479983, 38479984, 38479985, 38479986, 38507316, 38507317, 38507318, 38507319, 38507560, 38529186, 38529188, 38529189, 38529191, 38529193, 38529194, 38529195, 38529197, 38529198, 38529199, 38529380, 38529381, 38529383, 38529384, 38570828, 38570829, 38570830, 38589819, 38672653, 38672654, 38672655, 38726668, 38726669, 38726670, 38726671, 38726672, 38726673, 38726674, 38726675, 38734732, 38734733, 38734735, 38748256, 38748257, 38748258, 38748259, 38748401, 38800521, 38800522, 38800523, 38827801, 38827802, 38827803, 38827804, 38827805, 38827806, 38831789, 38831790, 38831791, 38831792, 38847493, 38847494, 38847495, 38847496, 38847497, 38847498, 38847499, 38847680, 38847681, 38878813, 38878814, 38878815, 38878816, 38878817, 38878818, 38886480, 38886481, 38916787, 38916788, 38916789, 38916790, 38933953, 38933954, 38933955, 38933956; Exp. November 23, 2028 March 25, 2029.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2626-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2627-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2628-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2629-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2630-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2631-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2632-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2633-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2634-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2635-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2636-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2637-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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