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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.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Class IIReported ongoing
Distribution: Worldwide distribution.
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Class IIReported ongoing
Distribution: Worldwide distribution.
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Class IIReported ongoing
Distribution: Worldwide distribution.
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
Class IIReported ongoing
Distribution: Worldwide distribution.
Cook Medical identified that catheters supplied in the affected device lots may experience tip separation.
Class IReported ongoing
Distribution: Worldwide distribution.
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Class IIReported ongoing
Distribution: worldwide - No US distribution.
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Belgium, Germany, Spain, France, Ireland, Italy Netherlands, Switzerland, South Africa, Slovenia.
Devices from the affected device lots have labels that state the incorrect expiration dates.
Class IIReported ongoing
Distribution: International Distribution to: Korea only
Affected device lots have labels that state the incorrect expiration dates.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Affected device lots have labels that state the incorrect expiration dates.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Cook Medical is conducting removal of a lot of Check-Flo Performer Introducer Set due to complaints that the white caps that connect the shaft to the hub of these products may disconnect.
Class IIReported ongoing
Distribution: International distribution to the country of Australia.
Product labels state the incorrect expiration dates that extends beyond their true expiration date
Class IIReported ongoing
Distribution: MA Foreign: Spain, and Netherlands
Product labels state the incorrect expiration dates that extends beyond their true expiration date
Class IIReported ongoing
Distribution: MA Foreign: Spain, and Netherlands
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
These examples come from this result page and are not a ranking of every recall reason.
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.
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.
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.
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.
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.