Cook Medical Incorporated recalls
Every recall we track for Cook Medical Incorporated — 50 in all, from 2018–2025 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Cook Medical Incorporated peaked in 2018 (39); 50 since 2017. 2% rated “stop using now”.
All FDA recall records for Cook Medical Incorporated since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 38 | 1 | 39 |
| 2019 | 0 | 0 | 4 | 2 | 6 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 2 | 0 | 2 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 2 | 0 | 2 |
| 2025 | 1 | 0 | 0 | 0 | 1 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Cook Medical Incorporated recalls
What to do if you have a recalled Cook Medical Incorporated product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Cook Medical Incorporated recalls
5 shown- Stop using nowMedical device
Cook Medical Incorporated recalls Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167
Cook Medical recalls Zenith Alpha 2 Thoracic Endovascular Grafts (ZTA2- prefix) due to potential PTFE coating scrapings that could cause intravascular embolization during deployment.
Cook MedicalSep 18, 2025 - Lower riskMedical device
Cook Medical Incorporated recalls EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
Cook Medical recalls EchoTip Ultra HD Endoscopic Ultrasound Access Needles (ECHO-HD-19-A, G52012) due to potential bacterial endotoxin contamination. Affected units may pose health risks during medical procedures.
Cook MedicalApr 1, 2024 - Lower riskMedical device
Cook Medical Incorporated recalls Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917;
Cook Medical is recalling Tulip Vena Cava Filter Sets for Femoral Vein Approach (catalog numbers IGTCFS-65-1-FEM-TULIP, IGTCFS-65-1-JUG-TULIP, IGTCFS-65-1-UNI-TULIP) manufactured from January 24, 2019 through January 24, 2022. This recall includes an update to device descriptions, intended use, contraindications, warnings, precautions, and potential adverse events.
Cook MedicalFeb 14, 2022 - Lower riskMedical device
Cook Medical Incorporated recalls Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C
Cook Medical recalls certain vena cava filter sets for femoral and jugular vein approaches due to updated instructions for use. This recall does not involve a safety hazard but requires users to review the latest instructions to ensure proper application.
Cook MedicalFeb 25, 2019 - Lower riskMedical device
Cook Medical Incorporated recalls Zilver 635 Biliary Stent 14mm x 30mm, Catalog Number: ZIB6-80-14.0-30 Product Usage: The Zilver 518 and 635 Biliary
Cook Medical recalls Zilver 635 Biliary Stent 14mm x 30mm (ZIB6-80-14.0-30) due to incorrect deployment instructions in the user manual. This correction prevents potential complications during stent placement.
Cook MedicalSep 25, 2018
Cook Medical Incorporated recall questions
How many recalls has Cook Medical Incorporated had?
50 recalls from Cook Medical Incorporated are on record with U.S. safety agencies, from 2018–2025.
What is the most recent Cook Medical Incorporated recall?
Cook Medical Incorporated recalls Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167, dated Sep 18, 2025. Every Cook Medical Incorporated recall is listed on this page, newest first.
Why are Cook Medical Incorporated products recalled?
The most common reasons on record: Updates to the Instructions for Use. (5); Devices may contain elevated levels of bacterial endotoxin. (2).
What should I do if I have a recalled Cook Medical Incorporated product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Cook Medical Incorporated recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.