Recall Z-2632-2026
Boston Scientific Corporation · initiated May 21, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
CRE Wireguided 6-8mm 240cm
Codes / lots: 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.
Reason for recall
Potential sterile breach of the pouches in which devices are packaged.
FDA-determined cause: Package design/selection
Action taken
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.
Details
- Recall number
- Z-2632-2026
- Initiated
- May 21, 2026
- Posted by FDA
- July 1, 2026
- Product code
- FDT – Duodenoscope And Accessories, Flexible/Rigid
- Quantity
- 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…
- Recalling firm
- Boston Scientific Corporation, Marlborough, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2626-2026 Class II | CRE Pro Wireguided 6-8mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2627-2026 Class II | CRE Pro Wireguided 8-10mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2628-2026 Class II | CRE Pro Wireguided 10-12mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2629-2026 Class II | CRE Pro Wireguided 12-15mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2630-2026 Class II | CRE Pro Wireguided 15-18mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2631-2026 Class II | CRE Pro Wireguided 18-20mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2633-2026 Class II | CRE Wireguided 8-10mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2634-2026 Class II | CRE Wireguided 10-12mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2635-2026 Class II | CRE Wireguided 12-15mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2636-2026 Class II | CRE Wireguided 15-18mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |
| Z-2637-2026 Class II | CRE Wireguided 18-20mm 240cmPotential sterile breach of the pouches in which devices are packaged. | 05/21/2026Open, Classified |