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35 reported ongoing
52 records in this archive. Latest source date Apr 30, 2026. 1 published notices do not supply a closure status.
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.
Some of the ambIT kits were potentially distributed without an air in-line filter.
Class IIReported terminated
Distribution: Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Some of the ambIT kits were potentially distributed without an air in-line filter.
Class IIReported terminated
Distribution: Worldwide distribution - US Nationwide distribution in the states of Texas and Oregon. The country of Australia.
Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
Class IReported terminated
Distribution: US Nationwide distribution in the state of Oklahoma.
Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
Class IReported terminated
Distribution: US Nationwide distribution in the state of Oklahoma.
Incorrect expiration date.
Class IIReported terminated
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Germany, Netherlands, France, Switzerland, Great Britain, Israel, and India.
Sterile extension sets were distributed without an expiration date
Class IIReported terminated
Distribution: US: CA, CO, FL, MI, NM, OH, OR, TN, TX, UT, WI
Product labeling is being modified. STOP using the Anonymous Account Mode feature of the CORTRAK 2 device immediately. CONFIRM placement of the NG/NI tube per institution protocol.
Class IReported terminated
Distribution: Worldwide Distribution. US Nationwide, Australia, Austria, Canada, Germany, Ireland, Kuwait, New Zealand, India, Japan, Malaysia, Netherlands, Panama, Singapore, Switzerland, an...
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Class IIReported terminated
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Chile.
The External Retention Bolster contained in the kit may be a larger diameter than the tube.
Class IIReported terminated
Distribution: Worldwide distribution - US Nationwide and the countries of Canada and Chile.
Product was distributed with incorrect expiration date.
Class IIReported terminated
Distribution: Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.
Product was distributed with incorrect expiration date.
Class IIReported terminated
Distribution: Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.
Product was distributed with incorrect expiration date.
Class IIReported terminated
Distribution: Worldwide distribution - US Nationwide distribution in the states of Oklahoma and Ohio; The countries of China, France, Germany, Great Britain, Greece, Italy, and Netherlands.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 52 records, including 35 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.