Cook Medical Incorporated
Complete recall history across all FDA and CPSC categories — 53 total recalls
Cook Medical Incorporated appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (53)
FDA medical device enforcement actions by Cook Medical Incorporated. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Sep 18, 2025 | Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference... | Affected devices may contain PTFE coating scrapings. Scrapings could be relea... | Class I |
| Apr 1, 2024 | EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520 | Devices may contain elevated levels of bacterial endotoxin. | Class II |
| Apr 1, 2024 | EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012 | Devices may contain elevated levels of bacterial endotoxin. | Class II |
| Feb 14, 2022 | Cook Celect PlatinumVena Cava Filter Set Catalog Number/GPN: IGTCFS-65-1-F... | IFU update includes an update to the Device description, Intended Use/Indica... | Class III |
| Feb 14, 2022 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/... | IFU update includes an update to the Device description, Intended Use/Indica... | Class III |
| Feb 25, 2019 | Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number... | Updates to the Instructions for Use. | Class III |
| Feb 25, 2019 | Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog... | Updates to the Instructions for Use. | Class III |
| Feb 25, 2019 | Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number... | Updates to the Instructions for Use. | Class III |
| Feb 25, 2019 | Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Ca... | Updates to the Instructions for Use. | Class III |
| Feb 25, 2019 | Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog... | Updates to the Instructions for Use. | Class III |
| Feb 25, 2019 | Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Appro... | Updates to the Instructions for Use. | Class III |
| Sep 25, 2018 | Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-80-4.0-80 Prod... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-125-5.0-40 Pro... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 40mm, Catalog Number: ZIB6-80-5.0-40 Prod... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 518 Biliary Stent 4mm x 30mm, Catalog Number: ZIB5-125-4.0-30 Pro... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver Biliary 518 Stent 5mm x 60mm, Catalog Number: ZIB5-125-5.0-60 Pr... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-80-5.0-60 Prod... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-125-12.0-60 P... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-80-14.0-60 Pr... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-125-12.0-30 P... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-80-14.0-80 Pr... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 4mm x 80mm, Catalog Number: ZIB6-125-4.0-80 Pro... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 518 Biliary Stent 5mm x 40mm, Catalog Number: ZIB5-125-5.0-40 Pro... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-125-12.0-80 P... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 518 Biliary Stent 5mm x 20mm, Catalog Number: ZIB5-125-5.0-20 Pro... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 518 Biliary Stent 4mm x 60mm, Catalog Number: ZIB5-125-4.0-60 Pro... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-80-5.0-80 Prod... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-125-12.0-40 P... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 40mm, Catalog Number: ZIB6-80-12.0-40 Pr... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Prod... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 518 Biliary Stent 4mm x 80mm, Catalog Number: ZIB5-125-4.0-80 Pro... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-80-14.0-40 Pr... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-125-5.0-80 Pro... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 518 Biliary Stent 4mm x 20mm, Catalog Number: ZIB5-125-4.0-20 Produ... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-125-5.0-20 Pro... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 518 Biliary Stent 4mm x 40mm, Catalog Number: ZIB5-125-4.0-40 Pro... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 30mm, Catalog Number: ZIB6-80-12.0-30 Pr... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 80mm, Catalog Number: ZIB6-80-12.0-80 Pr... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-125-14.0-30 P... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 518 Biliary Stent 5mm x 80mm, Catalog Number: ZIB5-125-5.0-80 Pro... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 40mm, Catalog Number: ZIB6-125-14.0-40 P... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 20mm, Catalog Number: ZIB6-80-5.0-20 Prod... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-125-5.0-30 Pro... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 60mm, Catalog Number: ZIB6-125-5.0-60 Pro... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 60mm, Catalog Number: ZIB6-125-14.0-60 P... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 80mm, Catalog Number: ZIB6-125-14.0-80 P... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 12mm x 60mm, Catalog Number: ZIB6-80-12.0-60 Pr... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 5mm x 30mm, Catalog Number: ZIB6-80-5.0-30 Prod... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 518 Biliary Stent 5mm x 30mm, Catalog Number: ZIB5-125-5.0-30 Pro... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
| Sep 25, 2018 | Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Pr... | The instruction for use detail, with respect to removal of the delivery syste... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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