Official recall record
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-11-03
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 00827002226579
- Brand on record
- Wilson-Cook Medical Inc.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
Other recalls from this brand
- 2023-11-03 · US FDA — Medical Devices
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-4X3, Order Number G22654; used to dilate strictures of the bilia - 2023-11-03 · US FDA — Medical Devices
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-6X3, Order Number G22655; used to dilate strictures of the bilia - 2023-11-03 · US FDA — Medical Devices
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3-E, Order Number G22667; used to dilate strictures of the bi
All 6 official recall notices naming Wilson-Cook Medical Inc. on this site →
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