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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.
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.
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 cir...
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide.
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 cir...
Class IReported ongoing
Distribution: Worldwide distribution - US Nationwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.
Class IIReported ongoing
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
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.