Boston Scientific Corporation: Medical Device Recall in 2024 - (Recall #: Z-2350-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective cannulation of the bile duct.

Product Classification:

Class II

Date Initiated: June 12, 2024

Date Posted: July 24, 2024

Recall Number: Z-2350-2024

Event ID: 94827

Reason for Recall:

Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.

Status: Ongoing

Product Quantity: 256 US, 39 OUS

Code Information:

UDI-DI (GTIN) 08714729444749 Lot 33280747 Expiration Date: January 23, 2027

Distribution Pattern:

Domestic distribution nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated