Cook Incorporated recall records

84 reported ongoing

85 records in this archive. Latest source date Apr 2, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and i...

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Class IIReported ongoing

Distribution: Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

Official source for Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (...
FDA device enforcement

Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838

The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering ...

Class IIReported completed

Distribution: US Nationwide. Brazil, Canada,

Official source for Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
FDA device enforcement

Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 ...

The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

Class IIReported ongoing

Distribution: Domestic distribution nationwide. Foreign distribution worldwide.

Official source for Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18...
FDA device enforcement

Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNAD...

The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

Class IIReported ongoing

Distribution: Domestic distribution nationwide. Foreign distribution worldwide.

Official source for Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 M...

Reasons in these listed records

  • Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
  • The products may contain excess coating material on the outside and/or interior of the needle component. Potential adverse events that may occur if an affected product is used include a delay in the procedure, a prolonged procedure, or particulate entering the bloodstream whic...
  • The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

These examples come from this result page and are not a ranking of every recall reason.

Checking Cook Incorporated

Is there a recall on cook incorporated right now?

This archive contains 85 records, including 84 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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