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11 reported ongoing
12 records in this archive. Latest source date Apr 30, 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.
Due to an increase rate of balloon pinhole defects.
Class IIReported ongoing
Distribution: Worldwide - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, KS, KY, LA, MI, MN, MO, MT, NC, NH, NM, NY, OH, PA, SD, TN, TX, WA, and WI. The countri...
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; ...
Class IIReported ongoing
Distribution: International distribution to the country of China.
Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdraw...
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of SD, CA, SC, TX, FL, CO, NE, NY and the countries of DE, ES, PL, GB, IT, IN, AU, KZ, JP, AT, SI, RS, GR, TR, AR, CH, SG, K...
Drug Elutable Microspheres have a smaller actual average diameter that is not within specification, which may lead to inability to reach the desired treatment location (non-targeted embolization), additional procedure/treatment required, blockage other than...
Class IIReported ongoing
Distribution: OUS: Italy, Spain, Portugal, Poland, Belgium, Germany, Denmark, France, Kazakhstan, Slovakia, Norway, Greece, Serbia, Turkey, Czech Republic, United Kingdom, Netherlands, Russia...
Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.
Class IIReported ongoing
Distribution: US: None OUS: China
Sterility assurance; microcatheter inner packaging may contain incomplete seal.
Class IIReported ongoing
Distribution: US: None OUS: China
Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.
Class IIReported ongoing
Distribution: U.S. Nationwide distribution in the states of AR, CA, FL, IN, LA, MA, MN, MO, NC, NJ, NY, OH, PA, SC, TX and VA.
Due to, during the manufacturing process, the prescribed manufacturing and quality processes were not followed and the product was inadvertently distributed.
Class IIReported ongoing
Distribution: U.S. Nationwide distribution in the states of AZ, IL, LA, NC, TN, VA, and WI.
Peripheral coil system detachable has a potential of unsealed pouch packaging.
Class IIReported ongoing
Distribution: US Nationwide distribution in the states of TX, NY, VA, NV, MI, CA, AZ, WA.
Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent length and may not perform as intended.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution including in the states of AZ, NY, FL, CA, PA, SC, TX, IL, MA, NJ, VA, GA, OH, IN, MI, KY, AL, MO, SD, LA, WA, HI, KS, MD, OK, DE, NC, MS ...
Detachment controller, of an aneurysm embolization system, has an out of specification tunnel opening dimension, which may prevent the implant device pusher from being fully inserted into the controller, which may result in the inability of the controller t...
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of MN, PA, NY, MI, FL, VA, TX, OH, CA, NE, MN, NC, LA, IL, TN, IN, UT, KS and the countries of Japan, China, Argentina, Aust...
Syringe Kits labeled for distribution OUS were inadvertently shipped to US customers.
Class IIReported terminated
Distribution: US Nationwide distribution in the states of AL, NY, NV.
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 12 records, including 11 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.