Coloplast Manufacturing US, LLC: Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

Recall number

Z-0844-2025

Recalling firm

Coloplast Manufacturing US, LLC

Product

Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.

Status

Open, Classified

Initiated

2024-12-02

Posted

2025-01-10

Terminated

not on file

Reason

A possible sterility issue was detected in Coloplast's facility on some Coloplast products.

Root cause

Packaging

Action

An URGENT MEDICAL DEVICE VOLUNTARY RECALL notification letter dated 12/2/24 was sent to customers. Distributors, it is imperative that you take immediate action to cascade this recall notice to all relevant subsidiaries and customers who may have received the affected product within your distribution network. Customers affected by this recall are kindly advised to immediately inspect their internal inventory and quarantine all products and samples of the items with the lot numbers mentioned in Appendix 1 and then proceed to safe destruction. Please contact Customer Service for any assistance: Email: IURecalls@coloplast.com Phone: +1 855 745 8549 Expenses will be refunded by Coloplast A/S upon receipt of the completed Certificate of Destruction provided in Appendix 2.

Quantity

226,452 units

Distribution

US Nationwide. Canada.

Lot, serial or model codes

Device Reference Number AA6106, GTIN 3600040126851, 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 ; Device Reference Number AA6108, GTIN 3600040126981, 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; Device Reference Number AA6110, GTIN 3600040127117, 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 ; Device Reference Number AA6112, GTIN 3600040127247, 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 ; Device Reference Number AA6114, GTIN 3600040127377, 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 ; Device Reference Number AA6116, GTIN 3600040127506, 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 ; Device Reference Number AA6118, GTIN 3600040127612, 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 ; Device Reference Number AA6120, GTIN 3600040127742, 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 ; Device Reference Number AA6122, GTIN 3600040127872, Lot Numbers 7405871, 7416497, 7748381, 7942074, 8350342, 8493250, 8519854, 8592989, 8728906, 8985443, 9159829, 9404773, 9445789, 9453600, 9453601, 9485195, 9829431 ; Device Reference Number AA6124, GTIN 3600040128008, Lot Numbers 7416543, 7516929, 7773792, 7850835, 8442227, 8442228, 8442229, 9008561, 9067848, 9656792 ; Device Reference Number AA6308, GTIN 3600040128268, 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 ; Device Reference Number AA6310, GTIN 3600040128398, 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 ; Device Reference Number AA6312, GTIN 3600040128527, 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 ; Device Reference Number AA6314, GTIN 3600040128657, 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 ; Device Reference Number AA6316, GTIN 3600040128787, 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 ; Device Reference Number AA6318, GTIN 3600040128916, 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 ; Device Reference Number AA6320, GTIN 3600040129043, 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 ; Device Reference Number AA6322, GTIN 3600040129173, Lot Numbers 7278629, 7427155, 7669083, 7883400, 8020995, 8341192, 8529360, 8806425, 8865242, 9077741, 9261332, 9529711 ; Device Reference Number AA6324, GTIN 3600040129302, Lot Numbers 7576086, 8781856 ; Device Reference Number AA6408, GTIN 3600040129548, 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 ; Device Reference Number AA6410, GTIN 3600040129654, Lot Numbers 7238889, 7328578, 7504537, 7727224, 7875897, 7968423, 8268274, 8279805, 8289260, 8313332, 8385000, 8572855, 8829332, 8911104, 9041019, 9090452, 9112040, 9122839, 9304740, 9351786, 9404766, 9485150, 9585499, 9597191, 9610626, 9622874, 9645254 ; Device Reference Number AA6412, GTIN 3600040129760, Lot Numbers 7469902, 7487192, 7575986, 7616927, 7657453, 7831467, 7850833, 7894943, 7969018, 8063393, 8484904, 8763741, 8865370, 8996597, 9540949, 9597147 ; Device Reference Number AA6414, GTIN 3600040129876, Lot Numbers 7188119, 7199212, 7440901, 7528790, 7576075, 7714004, 7883386, 7987202, 8157026, 8418146, 8506830, 8620089, 8829335, 8884416, 8931371, 9041046, 9404761, 9634304 ; Device Reference Number AA6416, GTIN 3600040129982, Lot Numbers 7350530, 7447481, 7564676, 7942073, 8030404, 8279949, 8289288, 8341195, 8392320, 8442223, 8506815, 8620005, 8691165, 8765660, 8806426, 8884587, 8911347, 8996693, 9112189, 9404768, 9656818, 9690317 ; Device Reference Number AA6418, GTIN 3600040130094, Lot Numbers 7504609, 7774381, 8728852, 8806464, 8839747, 8865340, 8931610, 9018807, 9315892, 9341121, 9405065, 9711524 ; Device Reference Number AA6420, GTIN 3600040130209, Lot Numbers 7405944, 7528861, 7748339, 8097883, 8174966, 8200073, 8221042 ; Device Reference Number AA6422, GTIN 3600040130315, Lot Numbers 7387180, 7494256, 7504533, 7835619, 7998860, 8072753, 8122937, 8289258, 8361032, 8572867, 8724746, 8853703, 8923157, 8931625, 9018923, 9253805, 9315714, 9420936, 9530112, 9683051 ; Device Reference Number AA6424, GTIN 3600040130421, Lot Numbers 7908254, 8097924, 8111874, 8539720, 8700221, 8865324, 9520261, 9711496 ; Device Reference Number AA6C18, GTIN 3600040132005, Lot Numbers 7576074, 7735670, 7835647, 8529292, 8763748, 8865410, 9090707, 9177753 ; Device Reference Number AA6C20, GTIN 3600040132135, Lot Numbers 7362291, 7405869, 7714003, 8679900 ; Device Reference Number AA6C22, GTIN 3600040132265, Lot Numbers 8055955, 8114931, 8114941, 8114965, 9690288 ; Device Reference Number AA6C24, GTIN 3600040132395, Lot Numbers 8114942, 8498233, 8603437, 8865331, 9132275, 9558659 ;

510(k) numbers

["K233411"]

PMA numbers

not on file

Product code

EZL

Firm FEI

2125050

Firm city

Minneapolis

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy