Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 13, 2023
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree
Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential harms associated with balloon detachment are endoscopic retrieval of an …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Wilson-Cook Medical Inc. recalled QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate s… - a moderate-severity action.
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate s… was recalled by Wilson-Cook Medical Inc. in December 13, 2023. Reason: Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential ha…. Check the official notice for the remedy. Verify recall #Z-0457-2024 with the FDA Devices before acting.
The recall
Wilson-Cook Medical Inc. issued this moderate-severity FDA Devices recall-Nonconforming devices while manufactured correctly, do not comply to their design requirements. Potential ha….
- Moderate
- severity level
- 731 units
- affected scope
- Class II
- classification
- December 13, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0457-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0457-2024) was formally reported on December 13, 2023, with the manufacturer initiating the action on November 3, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Wilson-Cook Medical Inc. is listed as the recalling firm, operating out of Winston Salem, NC. Federal records list the affected scope as 731 devices.
The documented reason for this recall is: 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, bleedin… Distribution data in the federal record shows the product reached: US. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
731 devices
Related Recalls
6
3 from same agency
Product description
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0457-2024 |
| Date reported | December 13, 2023 |
| Date initiated | November 3, 2023 |
| Recalling firm | Wilson-Cook Medical Inc. |
| Firm location | Winston Salem, NC |
| Affected scope | 731 devices |
| Distribution | US |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0457-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order Number G22657; used to dilate strictures of the biliary tree. Recalled by Wilson-Cook Medical Inc.. Units affected: 731 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 13, 2023. Severity: Moderate. Recall number: Z-0457-2024.
Where was the recalled product distributed? ▼
Distribution: US.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0457-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 13, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.