Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114...
FDA Device Recall #Z-0844-2025 — Class II — December 2, 2024
Recall Summary
| Recall Number | Z-0844-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 2, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Coloplast Manufacturing US, LLC |
| Location | Minneapolis, MN |
| Product Type | Devices |
| Quantity | 226,452 units |
Product Description
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.
Reason for Recall
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Distribution Pattern
US Nationwide. Canada.
Lot / Code Information
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 ;
Other Recalls from Coloplast Manufacturing US, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0845-2025 | Class II | X-Flow prostatectomy catheter, Device Reference... | Dec 2, 2024 |
| Z-1463-2024 | Class II | Ureteral dilator, REF RBD014 | Mar 11, 2024 |
| Z-1360-2023 | Class II | Titan Pump Assembly, Catalog Number 5177701400;... | Mar 1, 2023 |
| Z-1371-2023 | Class II | Titan Touch Scro Zero Ang 22cm, Catalog Number ... | Mar 1, 2023 |
| Z-1366-2023 | Class II | Titan NB Scrotal Zero Ang 18cm, Catalog Number ... | Mar 1, 2023 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.