Cook Medical Recalls Zilver 635 Biliary Stent Due to Instruction Error
Cook Medical is recalling 9,834 Zilver 635 Biliary Stents because the instruction for use contains incorrect details regarding the removal of the delivery system.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a documentation error (incorrect instructions) rather than a direct physical defect or reported injury, fitting the criteria for moderate severity involving minor labeling or documentation issues.
Plain-English summary
Cook Medical Incorporated is recalling 9,834 units of the Zilver 635 Biliary Stent 5mm x 30mm (Catalog Number: ZIB6-125-5.0-30). The recall is due to an error in the instruction for use (IFU) regarding the removal of the delivery system during stent deployment. The IFU is being corrected to amend these instructions.
The affected stents are intended for the palliation of malignant neoplasms in the biliary tree. The recall covers units distributed nationwide in the United States, including all 50 states, the District of Columbia, and Puerto Rico. The Global Product Number (GPN) for the affected product is G32031.
This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. No specific instructions for consumers are provided in the source text beyond the correction of the IFU.
The recalled product
- Product
- Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
- Manufacturer
- Cook Medical Incorporated
- Category
- Medical Device — Biliary Stent
- Hazard
- Affected units
- 9,834
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- GPN: G32031
Distribution
Part of a larger recall action
This product is one of 39 recalled by Cook Medical Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 39 products in this recall →Related recalls
Same manufacturer · Cook Medical Incorporated
See all →- CriticalThoracic endovascular grafts recalled over coating scrapings that may embolize
FDA (Devices) · 2025-10-22
- HighCook Medical EchoTip Ultra needle recalled due to elevated bacterial endotoxin levels
FDA (Devices) · 2024-05-22
- HighEchoTip Ultra HD Endoscopic Ultrasound Access Needle recalled for elevated bacterial endotoxin
FDA (Devices) · 2024-05-22
- ModerateVena Cava Filter Sets Recalled for Instruction for Use Documentation Updates
FDA (Devices) · 2022-04-13
- LowCook Celect Platinum Vena Cava Filter Set Instructions Recall
FDA (Devices) · 2022-04-13
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02