Reported Jan 22, 2025 · Ongoing
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118,…
Coloplast Manufacturing US, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Coloplast Manufacturing US, LLC · 1601 W River Rd · Minneapolis, MN · 55411-3431
Is this the product you have?
Folysil Silicone Foley CathetersDevice Reference Numbers AA6106AA6108AA6110AA6112AA6114AA6116AA6118AA6120AA6122AA6124AA6308AA6310AA6312AA6314AA6316AA6318AA6320AA6322AA6324AA6408AA6410AA6412AA6414AA6416AA6418AA6420AA6422AA6424AA6C18AA6C20AA6C22and AA6C24
- Lot codes and dates
32 of 32 products
Products covered by this recall Model / number Product as published 3600040126851Device Reference Number AA6106, , Lot Numbers 7278611, 7326825, 7469914, 7528770, 7540052, 7616917, 7680676, 7726724, 7748128, 7794789, 7874610, 7883406, 7948568, 7987184, 7987186, 7998885, 8097945, 8097947, 8097949, 8097950, 8149951, 8149954, 8156925, 8326511, 8326512, 8392428, 8452914, 8452915, 8519853, 8559628, 8572973, 8572977, 8728905, 8742746, 8796890, 8829455, 8899165, 8911320, 8996565, 9139298, 9177631, 9177632, 9192348, 9294521, 9294523, 9294524, 9315917, 9374195, 9404781, 9404782, 9419436, 9429227, 9429228, 9445801, 9453606, 9700652, 9711505, 9778601, 9778603, 9778606, 9792251, 9792257, 9817387, 9829471, 9843572, 9843573, 9940969 3600040126981Device Reference Number AA6108, , Lot Numbers 7278611, 7326825, 7469914, 7528770, 7540052, 7616917, 7680676, 7726724, 7748128, 7794789, 7874610, 7883406, 7948568, 7987184, 7987186, 7998885, 8097945, 8097947, 8097949, 8097950, 8149951, 8149954, 8156925, 8326511, 8326512, 8392428, 8452914, 8452915, 8519853, 8559628, 8572973, 8572977, 8728905, 8742746, 8796890, 8829455, 8899165, 8911320, 8996565, 9139298, 9177631, 9177632, 9192348, 9294521, 9294523, 9294524, 9315917, 9374195, 9404781, 9404782, 9419436, 9429227, 9429228, 9445801, 9453606, 9700652, 9711505, 9778601, 9778603, 9778606, 9792251, 9792257, 9817387, 9829471, 9843572, 9843573, 9940969 3600040127117Device Reference Number AA6110, , Lot Numbers 7255806, 7270683, 7270685, 7278618, 7303190, 7427087, 7440872, 7469982, 7487187, 7503933, 7564542, 7596635, 7629271, 7703729, 7713958, 7774417, 7774419, 7794951, 8133792, 8156966, 8156972, 8297224, 8313405, 8350384, 8519861, 8539757, 8679575, 8781871, 8796821, 8839854, 8839855, 8985535, 8996599, 9008443, 9031094, 9067753, 9077697, 9090464, 9102793, 9213533, 9213536, 9240194, 9240195, 9240196, 9240197, 9248068, 9261075, 9282360, 9282362, 9294615, 9294624, 9304466, 9315932, 9315933, 9341162, 9351850, 9351851, 9374230, 9385336, 9396721, 9405092, 9420752, 9420753, 9429249, 9445822, 9445823, 9472404, 9472405, 9553577, 9553578, 9610617, 9634462, 9634464, 9634465, 9656853, 9656854, 9656855, 9656856, 9656857, 9666697, 9666698, 9683046, 9683047, 9690316, 9700707, 9711520, 9792840, 9792841, 9843580, 9843581 3600040127247Device Reference Number AA6112, , Lot Numbers 7174166, 7174170, 7174172, 7338746, 7338747, 7338751, 7470039, 7576132, 7576144, 7585050, 7585053, 7607531, 7670529, 7680781, 7894977, 7929763, 7929766, 7929768, 7929772, 8030455, 8030458, 8122983, 8122990, 8289326, 8297221, 8313525, 8326570, 8326572, 8361200, 8472134, 8506837, 8559544, 8592891, 8679869, 8728871, 8796859, 8948101, 8985560, 9041086, 9102788, 9141405, 9177670, 9192341, 9240188, 9282330, 9282342, 9294599, 9341164, 9351839, 9351840, 9495897, 9529685, 9622813, 9634315, 9682510, 9682512, 9682513, 9690266, 9792211, 9792214, 9792217, 9792219, 9792220, 9792222, 9792236 3600040127377Device Reference Number AA6114, , Lot Numbers 7174266, 7238934, 7238937, 7290670, 7303277, 7328602, 7328604, 7362452, 7387284, 7396140, 7396147, 7441024, 7680769, 7735761, 7782360, 7782371, 7794999, 7795001, 7942148, 7942154, 7969037, 7998909, 8040737, 8040751, 8098020, 8289321, 8361123, 8361133, 8408149, 8418184, 8442278, 8592968, 8620070, 8679825, 8679833, 8679834, 8728885, 8853718, 8884537, 8911244, 8923138, 8948148, 8975016, 8985570, 8985571, 8985589, 9031124, 9031133, 9102804, 9122861, 9226662, 9226666, 9248080, 9351817, 9385277, 9419405, 9419408, 9453470, 9460169, 9485166, 9529697, 9558587, 9558600, 9585508, 9585518, 9597173, 9597181, 9610603, 9610606, 9700656, 9700662, 9737166, 9748487, 9748831, 9748832, 9755424, 9755427, 9755429, 9755439, 9780645, 9780646, 9780648, 9780661, 9780679, 9780683, 9792890, 9792891, 9792893 3600040127506Device Reference Number AA6116, , Lot Numbers 7193434, 7255904, 7314786, 7328608, 7328617, 7328618, 7406746, 7416574, 7447516, 7447523, 7487323, 7487328, 7494334, 7607523, 7680801, 7714102, 7794958, 7810306, 7883541, 7883545, 7942168, 8030469, 8087140, 8087162, 8111962, 8200198, 8268459, 8350405, 8361178, 8361186, 8418190, 8431498, 8442273, 8470200, 8472145, 8519842, 8529333, 8559608, 8572962, 8679849, 8679855, 8691267, 8728891, 8829399, 8829402, 8865298, 8884578, 8923523, 8948167, 8997529, 9008469, 9055014, 9077729, 9112123, 9141408, 9201829, 9240174, 9261058, 9261059, 9282296, 9294589, 9316028, 9341175, 9404784, 9429218, 9445790, 9453593, 9478195, 9495829, 9529688, 9540968, 9553558, 9558616, 9558618, 9585503, 9585504, 9610582, 9610598, 9622842, 9634401, 9634405, 9634423, 9634433, 9656837, 9666685, 9700700, 9700701, 9755483, 9755497 3600040127612Device Reference Number AA6118, , Lot Numbers 7161607, 7229862, 7278686, 7290713, 7350612, 7607542, 7657482, 7657485, 7735781, 7735785, 7794982, 7794987, 7836019, 7919589, 7919593, 7919604, 7948649, 7998889, 7998893, 8244807, 8244816, 8255400, 8289336, 8341241, 8460199, 8559580, 8572905, 8700341, 8742738, 8742739, 8749952, 8829462, 8948269, 9008685, 9008690, 9041121, 9067845, 9090781, 9102910, 9122821, 9143141, 9261278, 9261283, 9261293, 9304728, 9304733, 9362306, 9362321, 9472350, 9472368, 9559982, 9585591, 9585598 3600040127742Device Reference Number AA6120, , Lot Numbers 7174152, 7314709, 7314711, 7350584, 7362408, 7597839, 7607515, 7774397, 7883536, 7883538, 7942098, 7948628, 8350320, 8350322, 8442250, 8884440, 8985523, 9041132, 9201860, 9429193, 9429194, 9460760, 9460768, 9597150, 9711497, 9792240, 9792243 3600040127872Device Reference Number AA6122, , Lot Numbers 7405871, 7416497, 7748381, 7942074, 8350342, 8493250, 8519854, 8592989, 8728906, 8985443, 9159829, 9404773, 9445789, 9453600, 9453601, 9485195, 9829431 3600040128008Device Reference Number AA6124, , Lot Numbers 7416543, 7516929, 7773792, 7850835, 8442227, 8442228, 8442229, 9008561, 9067848, 9656792 3600040128268Device Reference Number AA6308, , Lot Numbers 7210663, 7440856, 7447457, 7470016, 7516834, 7528782, 7703710, 7761577, 7782071, 7810060, 7883513, 7919523, 7919524, 7977718, 7977720, 8111946, 8111947, 8268401, 8268407, 8326502, 8341188, 8452349, 8559594, 8572917, 8679560, 8817139, 8829340, 8839643, 9090446, 9122812, 9226586, 9240167, 9351797, 9351798, 9429188, 9485153, 9495821, 9634306, 9656800, 9682505, 9690261, 9940979, 9940980, 9940981, 9940982 3600040128398Device Reference Number AA6310, , Lot Numbers 7224527, 7270676, 7326836, 7503928, 7564546, 7575984, 7629249, 7669034, 7694121, 7782053, 7825239, 7850714, 7850715, 7874609, 7894935, 7942054, 7977212, 8008229, 8229393, 8268433, 8313522, 8350372, 8392310, 8392311, 8442257, 8484903, 8572971, 8572972, 8742701, 8742702, 8806409, 8865389, 8884593, 8996692, 9213520, 9304403, 9351788, 9404767, 9495819, 9505078, 9622811, 9634390, 9778578, 9940983, 9940985, 9940986, 9940987, 9940988 3600040128527Device Reference Number AA6312, , Lot Numbers 7174140, 7187848, 7187849, 7210666, 7278643, 7362305, 7396116, 7447574, 7540089, 7540090, 7585014, 7748371, 7748372, 7748373, 7894950, 7894951, 7894952, 8009485, 8009487, 8149941, 8149944, 8326518, 8392430, 8620093, 8700281, 8710124, 8710125, 8765639, 8765640, 8765642, 8839922, 8854150, 8865380, 8865381, 8931454, 8979454, 8979455, 9008570, 9008577, 9031600, 9077808, 9077809, 9112304, 9112305, 9112307, 9226831, 9226834, 9351873, 9351874, 9351875, 9385381, 9405093, 9420757, 9472413, 9472414, 9530032, 9541014, 9634457, 9634458, 9634459 3600040128657Device Reference Number AA6314, , Lot Numbers 7161409, 7199153, 7210671, 7270715, 7303239, 7328572, 7387266, 7597841, 7657501, 7748382, 7810282, 7810284, 7810285, 7883527, 7883528, 7883530, 7942127, 8021005, 8021008, 8021010, 8133760, 8133762, 8210455, 8268417, 8326563, 8361161, 8392440, 8431470, 8442240, 8506820, 8506824, 8506827, 8506829, 8592983, 8691234, 8781858, 8948130, 8996706, 9067761, 9090475, 9142760, 9192349, 9192350, 9315900, 9351810, 9351811, 9374199, 9396686, 9404795, 9405052, 9405054, 9405055, 9405056, 9419450, 9419451, 9429239, 9429242, 9429244, 9429245, 9445846, 9498282, 9498284, 9498291, 9520729, 9583957, 9583958, 9591036, 9683091, 9683093, 9683095 3600040128787Device Reference Number AA6316, , Lot Numbers 7270691, 7270693, 7270695, 7278620, 7338694, 7372033, 7372058, 7416502, 7440888, 7469922, 7502564, 7504465, 7516897, 7531041, 7543264, 7657521, 7657840, 7810293, 7810295, 7810298, 7874664, 7919607, 7919615, 7948692, 8009509, 8087237, 8156954, 8156959, 8229360, 8229362, 8279953, 8279964, 8289295, 8385832, 8431464, 8442233, 8442236, 8459903, 8506902, 8506911, 8592930, 8620035, 8710056, 8749908, 8765594, 8796808, 8829392, 8884465, 9018628, 9031089, 9031090, 9159876, 9177676, 9201834, 9248070, 9304424, 9304425, 9341146, 9341147, 9351832, 9351834, 9362253, 9362254, 9396699, 9396700, 9405074, 9405076, 9405078, 9405080, 9405082, 9420743, 9420747, 9429258, 9429259, 9429260, 9429264, 9446036, 9446037, 9498317, 9498319, 9498321, 9498325, 9498328, 9553608, 9583682, 9583685, 9583686, 9583951, 9597332, 9610632, 9666715, 9666718, 9666722, 9690346, 9711527, 9711528, 9780661 3600040128916Device Reference Number AA6318, , Lot Numbers 7187853, 7187855, 7187856, 7210690, 7314706, 7338701, 7387255, 7441009, 7494299, 7540104, 7624498, 7624499, 7774405, 7774409, 7774410, 7836009, 7836010, 7873737, 7874459, 7883405, 7894833, 7909021, 7919584, 7919587, 8063418, 8149978, 8210437, 8326549, 8452921, 8519805, 8519806, 8592976, 8656364, 8710067, 8710071, 8884562, 8899156, 8899157, 8931469, 8948191, 8948192, 9018829, 9055044, 9112167, 9192342, 9248025, 9261042, 9341126, 9341127, 9351828, 9351829, 9351830, 9374215, 9405067, 9419447, 9429238, 9445816, 9472419, 9472424, 9472428, 9505200, 9505205, 9505210, 9597325, 9683098 3600040129043Device Reference Number AA6320, , Lot Numbers 7470031, 7564265, 7564548, 7694153, 7748259, 7859432, 7859433, 7968997, 7968998, 8111929, 8111931, 8350380, 8408104, 8529305, 8620018, 8620019, 8765651, 8796853, 9102809, 9159909, 9177740, 9261105, 9461967, 9634310, 9656805 3600040129173Device Reference Number AA6322, , Lot Numbers 7278629, 7427155, 7669083, 7883400, 8020995, 8341192, 8529360, 8806425, 8865242, 9077741, 9261332, 9529711 3600040129302Device Reference Number AA6324, , Lot Numbers 7576086, 8781856 3600040129548Device Reference Number AA6408, , Lot Numbers 7161423, 7255852, 7314698, 7338705, 7487153, 7494196, 7503941, 7564628, 7859393, 7919509, 8122919, 8296919, 8313327, 8473741, 8498208, 8559595, 8710047, 8763704, 8829389, 8865402, 9520259, 9529677, 9622807, 9634305 - Amount recalled
- 226,452 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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