CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM recall
CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM…
Why was CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM recalled?
Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All devices/lots manufactured prior to and including August 2025 are affected. REF/UDI-DI: FCX100202/10886704083986, FCX100253/10886704083979, FCX100305/10886704083962, FCX100356/10886704083993, FCX100407/10886704084013, FCX100412/10886704084006, FCX100509/10886704084037, FCX100517/10886704084020, FCX100611/10886704084044, FCX100626/10886704084051, FCX100713/10886704084068, FCX100730/10886704084075, FCX100816/10886704084082, FCX100829/10886704084099, FCX140225/10886704084167, FCX140303/10886704084174, FCX140304/10886704084181, FCX140306/10886704084198, FCX140406/10886704084211, FCX140408/10886704084228, FCX140445/10886704084204, FCX140507/10886704084242, FCX140512/10886704084235, FCX140609/10886704084266, FCX140615/10886704084259, FCX140711/10886704084273, FCX140717/10886704084280, FCX140812/10886704084297, FCX140820/10886704084303, FCX140914/10886704084310, FCX140922/10886704084327, FCX141016/10886704084105, FCX141025/10886704084112, FCX141118/10886704084129, FCX141127/10886704084136, FCX141219/10886704084143, FCX141230/10886704084150, FCX180510/10886704084464, FCX180612/10886704084471, FCX180714/10886704084488, FCX180813/10886704084495, FCX180830/10886704084501, FCX180915/10886704084518, FCX180933/10886704084525, FCX181017/10886704084334, FCX181034/10886704084341, FCX181118/10886704084358, FCX181137/10886704084365, FCX181220/10886704084372, FCX181240/10886704084389, FCX181343/10886704084396, FCX181447/10886704084402, FCX181550/10886704084419, FCX181647/10886704084426, FCX181750/10886704084433, FCX181846/10886704084440, FCX181950/10886704084457, FCX182050/10886704082880, MCR091010/10886704082897, MCR091015/10886704082903, MCR091020/10886704082910, MCR091025/10886704082927, MCR091030/10886704082934, MCR091040/10886704082941, MCR091520/10886704082958, MCR091525/10886704082965, MCR091530/10886704082972, MCR091540/10886704082989, MCR092020/10886704084778, MCR092030/10886704082996, MCR092040/10886704083009, MCR092060/10886704083016, MCR092535/10886704083023, MCR092545/10886704083030, MCR092555/10886704083047, MCR093040/10886704083054, MCR093060/10886704083061, MCR093080/10886704083078, SCR120202/10886704083085, SCR120306/10886704083092, SCR120308/10886704083108, SCR120407/10886704083115, SCR120410/10886704083122, SCR120412/10886704083139, SCR120510/10886704083146, SCR120515/10886704083153, SCR120610/10886704083160, SCR120615/10886704083177, SCR120620/10886704083184, SCR120715/10886704083191, SCR120721/10886704083207, SCR120815/10886704083214, SCR120824/10886704083221, SCR120925/10886704083238, SCR121030/10886704083245, SCR121230/10886704083252, SCR122505/10886704083269, SCR122535/10886704083276, SCR123509/10886704083283, SCR123575/10886704083290, SHD100154/10886704083306, SHD100208/10886704083313, SHD100250/10886704083320, SHD100258/10886704083337, SHD100308/10886704083344, SHD100310/10886704083351, SHD100408/10886704083368, SHD100410/10886704083375, SHD100510/10886704083382, SHD100515/10886704083399, SHD100612/10886704083405, SHD100616/10886704083412, SHD100716/10886704083429, SHD100720/10886704083436, SHD100820/10886704083443, SHD100925/10886704083450, SHD180312/10886704083467, SHD180415/10886704083474, SHD180520/10886704083481, SHD180625/10886704083498, SHD180733/10886704083504, SHD180835/10886704083511, SHD180935/10886704083528, SHD181040/10886704083535, SHD181242/10886704083542, SHD181445/10886704083559, SHD181650/10886704083566, SHD181855/10886704083573, SHD182060/10886704083580, SHD182260/10886704083597, SHD182460/10886704083603, XCR120201/10886704083610, XCR120202/10886704083627, XCR120304/10886704083634, XCR120306/10886704083641, XCR120308/10886704083658, XCR120406/10886704083665, XCR120408/10886704083672, XCR120410/10886704083689, XCR120510/10886704083696, XCR120515/10886704083702, XCR120610/10886704083719, XCR120620/10886704083726, XCR122505/10886704083733, XCR122525/10886704083740, XCR122535/10886704083757, XCR123505/10886704083764, XCR123509/10886704083771, XCR123575/10886704083788, XHD100151/10886704083795, XHD100152/10886704083801, XHD100153/10886704083818, XHD100201/10886704083825, XHD100202/10886704083832, XHD100203/10886704083849, XHD100204/10886704083856, XHD100206/10886704083863, XHD100254/10886704083870, XHD100256/10886704083887, XHD100304/10886704083894, XHD100306/10886704083900, XHD100406/10886704083917, XHD100408/10886704083924, XHE120204/10886704083931, XHE120206/10886704083948, XHE120208/10886704083955, MDH1/10886704084600
- Product
- CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UNIFORM 2.5MM X 3.3 CM/FCX100253, UNIFORM 3MM X 5.4 CM/FCX100305, UNIFORM…
- Recalling firm
- Cerenovus Inc
- Quantity
- 12004
- Distribution
- US Nationwide distribution: CO, GA, MD, UT, OK, WI, MA, TN, SC, TX, CA, WV, LA, IL, NY, IA, AZ, AL, CT, WA, OH, ME, DC, FL, SD, KY, NJ, DE, NC, PA, MI, MO, VA, NH, NV and OR.
- Recall date
- November 19, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)