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Cook Incorporated

Cook Incorporated Recalls

All product recalls associated with Cook Incorporated.

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Recall Summary

Total Recalls

51

Past Year

7

Class I (Serious)

0

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 51 recalls

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

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

Page 2 of 3Next

Nationwide

• Cook Incorporated

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: Fixed Core Wire Guide (Straight), 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: Torq-Flex Wire Guide Australian Modification, Guidewire R...

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: Rosen Curved Wire Guide, Guidewire Reference Part Number/...

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: Vinyl Connecting Tube, Connecting Tube Reference Part Num...

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: Lunderquist -Ring Torque Wire Guide, Guidewire Reference ...

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: Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guid...

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: Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Re...

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: Roadrunner PC Wire Guide (The Firm LT), Guidewire Referen...

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: Cope Mandril Wire Guide (Stainless Steel), Stainless Stee...

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: Newton Wire Guide (LT Taper/10cm Distal Flexibility), Gui...

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: Double Flexible Tipped Wire Guide, Guidewire Reference Pa...

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: Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewi...

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: Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY...

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: Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibili...

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: Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part ...

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: Bentson Wire Guide (20cm Distal Flexibility with Softened...

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