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352 reported ongoing
354 records in this archive. Latest source date Aug 6, 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.
Sterility of device is compromised due to a sterile barrier breach
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britai...
Sterility of device is compromised due to a sterile barrier breach
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britai...
Sterility of device is compromised due to a sterile barrier breach
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britai...
Sterility of device is compromised due to a sterile barrier breach
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britai...
Sterility of device is compromised due to a sterile barrier breach
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britai...
Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.
Class IIReported terminated
Distribution: Worldwide distribution - US Nationwide distribution in the states of FL, NV, NY, OH, PA, and WA. The countries of Germany.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Class IIReported ongoing
Distribution: US Nationwide distribution.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Class IIReported ongoing
Distribution: US Nationwide distribution.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Class IIReported ongoing
Distribution: US Nationwide distribution.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Class IIReported ongoing
Distribution: US Nationwide distribution.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Class IIReported ongoing
Distribution: US Nationwide distribution.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Class IIReported ongoing
Distribution: US Nationwide distribution.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Class IIReported ongoing
Distribution: US Nationwide distribution.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Class IIReported ongoing
Distribution: US Nationwide distribution.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 354 records, including 352 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.