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Cook Incorporated

Cook Incorporated Recalls

All product recalls associated with Cook Incorporated.

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Recall Summary

Total Recalls

163

Past Year

7

Class I (Serious)

5

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–40 of 163 recalls

Ultrathane Mac-Loc Drainage Catheter (Cook) – Incorrect Expiration (2024)

Product labels state the incorrect expiration dates that extends beyond their true expiration date

FDAMay 15, 2024MA• Cook Incorporated

Ultrathane Cook-Cope Drainage Catheter (Cook) – Incorrect Expiration (2024)

Product labels state the incorrect expiration dates that extends beyond their true expiration date

FDAMay 15, 2024MA• Cook Incorporated

EchoTip Ultrasound Needle (Cook) – Bacterial Endotoxin Levels (2024)

Devices may contain elevated levels of bacterial endotoxin.

FDAApr 1, 2024IN• Cook Medical Incorporated

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EchoTip Ultrasound Needle (Cook) – Bacterial Endotoxin Levels (2024)

Devices may contain elevated levels of bacterial endotoxin.

FDAApr 1, 2024IN• Cook Medical Incorporated

Cook Incorporated: Dilator With AQ Hydrophilic Coating - Intended to be used...

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

FDAMar 1, 2024Nationwide• Cook Incorporated

Cook Incorporated: Yueh Centesis Disposable Catheter Needle - Intended for u...

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

FDAMar 1, 2024Nationwide• Cook Incorporated

Cook Incorporated: Dilator - Intended to be used for dilating puncture sites...

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

FDAMar 1, 2024Nationwide• Cook Incorporated

Cook Incorporated: Dilator - Coons Taper - Used for dilating puncture sites ...

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

FDAMar 1, 2024Nationwide• Cook Incorporated

Cook Incorporated: Chiba Biopsy Needle - Used for aspiration biopsy. REFERE...

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

FDAMar 1, 2024Nationwide• Cook Incorporated

Cook Incorporated: Trocar Needle - Used for dilating puncture sites or cathe...

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

FDAMar 1, 2024Nationwide• Cook Incorporated

Cook Incorporated: Peel-Away Introducer - Intended for the percutaneous intr...

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

FDAMar 1, 2024Nationwide• Cook Incorporated

Cook Incorporated: Entuit Secure Adjustable Gastrointestinal Suture Anchor S...

Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility

FDAMar 1, 2024Nationwide• Cook Incorporated

Wilson-Cook Medical Inc.: QUANTUM TTC BILIARY BALLOON DILATOR, REF QBD-10X3, Order...

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.

FDANov 3, 2023Nationwide• Wilson-Cook Medical Inc.

Chocolate Chip Cookie Dough (Cookies-n-Milk) – Undeclared Peanut (2023)

Undeclared Nuts

Undeclared Peanut Butter; Packaged Peanut Butter Dough in Chocolate Chip packaging.

FDASep 27, 2023IN, IA, KS +7 more• Cookies-n-Milk Incorporated

Cook Vandergrift, Inc.: Cook Lead Clipper- An auxiliary tool indicated for use in...

Sterility of device may be compromised due to breach of the chevron seal of the packaging

FDAJul 24, 2023Nationwide• Cook Vandergrift, Inc.

Wilson-Cook Medical Inc.: Fusion Lithotripsy Extraction Basket, Model Number FS-LXB...

Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).

FDAJun 22, 2023Nationwide• Wilson-Cook Medical Inc.

Wilson-Cook Medical Inc.: Hemospray Endoscopic Hemostat: Reference Part Numbers: ...

There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.

FDAMay 22, 2023Nationwide• Wilson-Cook Medical Inc.

Cook Incorporated: Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer ...

There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories.

FDAApr 7, 2023Nationwide• Cook Incorporated

Cook Incorporated: Coons Interventional Wire Guide, Guidewire; Reference Par...

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

FDAAug 16, 2022Nationwide• Cook Incorporated

Cook Incorporated: Fixed Core Wire Guide, Guidewire Reference Part Number/GP...

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

FDAAug 16, 2022Nationwide• Cook Incorporated