Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
Class IReported ongoing
Distribution: Domestic distribution to AL AR AZ CA CT DC DE FL GA IL IN LA MA MD MI MN MO NC NJ NY OH OR PA SC TN TX UT VA WA WI WV International distribution to Switzerland, Germany, Italy, ...
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Class IIIReported terminated
Distribution: US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
Class IIIReported terminated
Distribution: US Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile Guam
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
Devices may contain elevated levels of bacterial endotoxin.
IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events
These examples come from this result page and are not a ranking of every recall reason.
Checking Cook Medical Incorporated
Is there a recall on cook medical incorporated right now?
This archive contains 5 records, including 3 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.