Wilson-Cook Medical Inc.: Medical Device Recall in 2023 - (Recall #: Z-0457-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree

Product Classification:

Class II

Date Initiated: November 3, 2023

Date Posted: December 13, 2023

Recall Number: Z-0457-2024

Event ID: 93326

Reason for Recall:

Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an impacted or non-impacted object, bleeding caused by the retrieval device, or the incident can occur without injury and the object is left to pass naturally.

Status: Ongoing

Product Quantity: 731 devices

Code Information:

UDI/DI 00827002226579 (each), 10827002226576 (case), Lot Numbers: W4746514, W4746515, W4753822, W4756371, W4756904, W4720845, W4721268, W4722642, W4722645, W4722982, W4723311, W4724690, W4738719, W4739842, W4740111, W4746917, W4747437, W4747835, W4748251, W4748466, W4748945, W4748964, W4749235, W4749509, W4750012, W4750870, W4750909, W4751106, W4751509, W4752279, W4752282, W4752904, W4752906, W4752907, W4753363, W4753364, W4753366, W4754261, W4754262, W4754850, W4754851, W4755407, W4756476, W4758648, W4758928, W4759512, W4759979, W4760465, W4760865, W4761224, W4762151

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated