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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.
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.
Potential for unsealed sterile packing.
Class IIReported ongoing
Distribution: Worldwide distribution.
Medtronic is writing to inform you of incorrect labeling for three manufactured lots of the DLP Vessel Cannulae for the model and lot numbers listed above.
Class IIReported ongoing
Distribution: US and Brazil, Canada, Republic of Georgia, Germany, India, Ireland, Italy, Malaysia, South Africa, UK
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion ci...
Class IIReported ongoing
Distribution: Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Br...
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion ci...
Class IIReported ongoing
Distribution: Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Br...
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion ci...
Class IIReported ongoing
Distribution: Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Br...
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion ci...
Class IIReported ongoing
Distribution: Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Br...
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion ci...
Class IIReported ongoing
Distribution: Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Br...
An upward trend of complaints in which the Temperature Monitoring Adapter (TMA), located on the Affinity Fusion Oxygenator, had come loose from the oxygenator either during pre-procedure perfusion set-up or post-procedure when disassembling the perfusion ci...
Class IIReported ongoing
Distribution: Worldwide distribution. US Nationwide, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Belgium, Plurinational State of Bolivia, Bosnia And Herzegovina, Botswana, Br...
Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide distribution in the states of CA, ND, MA, ID, WI, KS, UT, MN, NY, NJ, GA, MO and the countries of Australia, Belgium, China, Czech Republi...
Product is labeled as non-pyrogenic but endotoxin testing was not performed.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CT, IL, IN, KY, MA, ME, MS, NY, OH, RI, TN, TX, and VA. The countries of Canada, Columbia, Franc...
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.