QUANTUM TTC BILIARY BALLOON DILATOR — Class II medical device recall Z-0462-2024
Ongoing recall by Wilson-Cook Medical Inc., reported 2023-12-13. Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harm
| Recall number | Z-0462-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wilson-Cook Medical Inc., Winston Salem, NC, United States |
| Recall initiated | 2023-11-03 |
| Classified | 2023-12-01 |
| Reported by FDA | 2023-12-13 |
| Quantity | 888 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00827002226562, 10827002226569 |
| Lot numbers | W4720844, W4721266, W4721791, W4722154, W4722156, W4722983, W4722985, W4724319, W4724691, W4737429, W4737766, W4737768, W4738716, W4740112, W4746516, W4746518, W4746916, W4746918, W4747433, W4747435, W4747436, W4747834, W4748247, W4748248, W4748467, W4748468, W4748476, W4748944, W4748963, W4749746, W4749747, W4750013, W4750869, W4751107, W4751110, W4751335, W4751516, W4752277, W4752278, W4752280 and 14 more |
| Model numbers | QBD-8X3 |
Product
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-8X3, Order Number G22656; used to dilate strictures of the biliary tree
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0462-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.