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323 reported ongoing
327 records in this archive. Latest source date Aug 18, 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.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class IIReported ongoing
Distribution: International distribution to the country of Japan.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class IIReported ongoing
Distribution: International distribution to the country of Japan.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class IIReported ongoing
Distribution: International distribution to the country of Japan.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class IIReported ongoing
Distribution: International distribution to the country of Japan.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class IIReported ongoing
Distribution: International distribution to the country of Japan.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class IIReported ongoing
Distribution: International distribution to the country of Japan.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class IIReported ongoing
Distribution: International distribution to the country of Japan.
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class IIReported ongoing
Distribution: International distribution to the country of Japan.
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, CL, DE, HK, JP, SG.
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manu...
Class IIReported ongoing
Distribution: Worldwide Distribution: US (Nationwide) and OUS (International) countries to: Algeria, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Belarus, Belgium, Ben...
Preset treatment parameters are not consistently being used in accordance with the IFU.
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of AU, CA, SG, DE, JP, HK.
Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Class IReported ongoing
Distribution: US nationwide distribution.
Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
Class IReported ongoing
Distribution: US Nationwide Distribution
Potential for distal tip tearing of the Mechanical Lithotriptor V.
Class IIReported ongoing
Distribution: US Nationwide distribution.
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class IIReported ongoing
Distribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulga...
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class IIReported ongoing
Distribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulga...
The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class IIReported ongoing
Distribution: US Nationwide distribution and International: Algeria, Armenia, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Belize, Benin, Bolivia, Bosnia-Herz., Brazil, Bulga...
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 327 records, including 323 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.