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56 reported ongoing
56 records in this archive. Latest source date Jun 24, 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.
During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Class IIReported ongoing
Distribution: US Nationwide. Global Distribution.
Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of Hawaii and New York.
As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E70 error code during normal operation. When this occurs, the touch screen may become temporarily unresponsive and go blank for up to two minutes before recoveri...
Class IIReported ongoing
Distribution: US Nationwide distribution.
Medtronic identified an Affinity NT Oxygenator unit with decreased CO2 gas transfer rates that did not meet performance requirements.
Class IIReported ongoing
Distribution: US States: AZ, CA, TN
The catheters may not retain their shape.
Class IReported ongoing
Distribution: Worldwide - US Nationwide distribution.
The catheters may not retain their shape.
Class IReported ongoing
Distribution: Worldwide - US Nationwide distribution.
The catheters may not retain their shape.
Class IReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use - procedure delay. Potential harm if not identified and used - stroke (reversible and irreversible).
Class IReported ongoing
Distribution: Domestic distribution nationwide. International distribution to the following countries: Albania Algeria Argentina Armenia Australia Austria Azerbaijan Bahrain Bangladesh Belaru...
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
Class IIReported ongoing
Distribution: US: NY, OH, IL, NJ, MI, TN, WI, Australia, and Singapore
During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage Venous Cannulae - right angle metal tip (Model 67312).
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Cambodia, Greece, Ireland, Italy, Saudi Arabia, Switzerland, United Kingdom, Viet Nam.
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of MN, MA, UT, CA, and FL. The countries of Japan and Slovenia.
Potential for unsealed sterile packing.
Class IIReported ongoing
Distribution: Worldwide distribution.
Potential for unsealed sterile packing.
Class IIReported ongoing
Distribution: Worldwide distribution.
Potential for unsealed sterile packing.
Class IIReported ongoing
Distribution: Worldwide distribution.
Potential for unsealed sterile packing.
Class IIReported ongoing
Distribution: Worldwide distribution.
Potential for unsealed sterile packing.
Class IIReported ongoing
Distribution: Worldwide distribution.
Potential for unsealed sterile packing.
Class IIReported ongoing
Distribution: Worldwide distribution.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 56 records, including 56 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.