---
title: "QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used t... — FDA record Z-0459-2024 | Is It on Recall"
description: "Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopi"
url: https://isitonrecall.com/recall/fda-device-z-0459-2024-quantum-ttc-biliary-balloon-dilator-ref-qbd-4x3-order-number-g22654-used-to-dilate-strictures-of-the/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree — FDA record Z-0459-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 3, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the biliary tree
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: Wilson-Cook Medical Inc.
- **Quantity**: 553 devices
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0459-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0459-2024%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI/DI 00827002226548 (each), 10827002226545 (case), Lot Numbers: W4720848, W4721792, W4721795, W4722159, W4722981, W4723304, W4723846, W4724692, W4737576, W4738717, W4742525, W4743193, W4743605, W4743606, W4743607, W4743608, W4744022, W4744441, W4748043, W4748946, W4749748, W4750264, W4750265, W4750910, W4751772, W4751906, W4751914, W4753360, W4753361, W4753362, W4753365, W4753816, W4755138, W4756901, W4756903, W4756905, W4757732, W4758647, W4759511, W4759976, W4760715, W4761738, W4761740, W4761935, W4762150 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Report date**: Dec 13, 2023
- **Recall initiation date**: Nov 3, 2023
- **Center classification date**: Dec 1, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0459-2024%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Wilson-Cook Medical Inc. records](https://isitonrecall.com/brand/wilson-cook-medical-inc/)