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44 reported ongoing
45 records in this archive. Latest source date Mar 11, 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.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
There is a potential for sterile package breach.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Canary Islands, Colombia, Finland, Germany, Netherlands, Portugal, Spain, Switzerland, United Arab Emirate...
During internal review of Polaris battery assembly data from the HiPot operation, a test systems engineer noticed that some batteries had gone through the High Potential test twice. This was able to occur because the test screen did not prevent retesting af...
Class IIReported ongoing
Distribution: US Nationwide distribution in the state of Florida.
Seal defects could compromise the ability of the product packaging to maintain sterility.
Class IIReported completed
Distribution: US Nationwide distribution in the state of MN.
It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activi...
Class IIReported ongoing
Distribution: US and Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Liec...
The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, Unit...
The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, Unit...
The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, one on each side of the manifold. These stickers label the common carotid artery (CCA) proximal balloon and external carotid artery (ECA) distal balloon inflation...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Algeria, Armenia, France, Germany, Iraq, Italy, Japan, Netherlands, Poland, Romania, Spain, Sweden, Switzerland, Unit...
Update to IFU provides a manual deployment workaround method to help mitigate potential harms related to partial stent deployment.
Class IIReported ongoing
Distribution: worldwide
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 45 records, including 44 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.