Recall Z-2629-2026— Boston Scientific Corporation

Name: FDA recall Z-2629-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-21

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2026-05-21. It names one FDA 510(k) clearance: K112994. Product: CRE Pro Wireguided 12-15mm 240cm. Reason: Potential sterile breach of the pouches in which devices are packaged..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-05-21
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K112994 — CRE DITATATION BALLONBoston Scientific Corporation·cleared 2012-02-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CRE Pro Wireguided 12-15mm 240cm

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.