---
title: "QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used t... — FDA record Z-0462-2024 | 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-0462-2024-quantum-ttc-biliary-balloon-dilator-ref-qbd-8x3-order-number-g22656-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-8X3, Order Number G22656; used to dilate strictures of the biliary tree — FDA record Z-0462-2024

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-8X3, Order Number G22656; 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**: 888 devices
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0462-2024

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0462-2024%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 00827002226562 (each), 10827002226569 (case), Lot Numbers: W4737768, W4746516, W4746916, W4747433, W4747834, W4748247, W4748468, W4748476, W4748944, W4749747, W4750013, W4751335, W4754263, W4756372, W4757274, W4720844, W4721266, W4721791, W4722154, W4722156, W4722983, W4722985, W4724319, W4724691, W4737429, W4737766, W4738716, W4740112, W4746518, W4746918, W4747435, W4747436, W4748248, W4748467, W4748963, W4749746, W4750869, W4751107, W4751110, W4751516, W4752277, W4752278, W4752280, W4752905, W4754118, W4754254, W4754257, W4756474, W4757277, W4758165, W4760467, W4760864, W4761747, W4762155 |

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-0462-2024%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/)