Cook Medical Recalls Zilver 635 Biliary Stents Due to Incorrect Instructions
Cook Medical is recalling 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) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cook Medical Incorporated is recalling 9,834 units of the Zilver 635 Biliary Stent 12mm x 30mm (Catalog Number: ZIB6-125-12.0-30). The recall was initiated because the instruction for use (IFU) contains incorrect details regarding the removal of the delivery system as part of the stent deployment process. The manufacturer is correcting the IFU to amend these instructions.
The affected stents are intended for the palliation of malignant neoplasms in the biliary tree. The products were distributed nationwide in the United States, including all 50 states, the District of Columbia, and Puerto Rico.
The source text does not specify specific actions for consumers or patients, nor does it report any illnesses or injuries associated with this recall. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30 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: G36238
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