Lower risk Medical device recall · FDA · Published December 2, 2024
Coloplast X-Flow Prostatectomy Catheter Recall: Possible Sterility Issue
Coloplast recalls X-Flow prostatectomy catheters with specific device reference numbers and lot numbers due to a possible sterility issue detected in their facility.
Lower-risk recall
A possible sterility issue was detected in Coloplast's facility on some Coloplast products.
Contact the company
Recalling firmColoplast Manufacturing US, LLC1601 W River Rd · Minneapolis, MN 55411-3431
What happened, in plain English
Coloplast is recalling certain X-Flow prostatectomy catheters that were manufactured with a possible sterility issue. This could lead to infection if the catheter is used without proper sterilization. Read more at govinfonow.com/recall/53370-coloplast-x-flow-prostatectomy-catheter-recall-possible-sterility-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/53370-coloplast-x-flow-prostatectomy-catheter-recall-possible-sterility-issue · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0845-2025
Cite this page
“Coloplast X-Flow Prostatectomy Catheter Recall: Possible Sterility Issue.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53370-coloplast-x-flow-prostatectomy-catheter-recall-possible-sterility-issue. Based on FDA recall #Z-0845-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0845-2025%22&limit=1).
Why it’s dangerous
The recall is based on a possible sterility issue detected in Coloplast's facility. This means the catheters might not be properly sterilized, increasing the risk of infection if used in medical procedures.
Who’s affected
Patients who have been prescribed or received these specific X-Flow prostatectomy catheters are likely affected. Healthcare providers using these catheters for surgical procedures may also be at risk.
How to tell if you have this one
Check the device reference numbers (AB6022, AB6024, etc.) and lot numbers listed in the recall notice. These catheters were sold with specific GTINs and lot numbers as detailed in the recall.
- Brand
Coloplast- Product
X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide. Canada.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0844-2025 | 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.; 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 ; | 226,452 units |
| Z-0845-2025 | X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.; Device Reference Number AB6022, GTIN 3600040143377, Lot Numbers: 8884608, 9132241, 9213522, 9396680, 9404775, 9495823, 9495824 ; Device Reference Number AB6024, GTIN 3600040143506, Lot Numbers: 8156931, 8865281, 9102857, 9453594 ; Device Reference Number AB6118, GTIN 3600040143636, Lot Numbers: 8691180; Device Reference Number AB6120, GTIN 3600040143728, Lot Numbers: 8839916, 9090719, 9112199, 9177734, 9622870, 9690290 ; Device Reference Number AB6122, GTIN 3600040143810, Lot Numbers: 7562886, 7562887; Device Reference Number AB6124, GTIN 3600040143902, Lot Numbers: 7396107, 9102869, 9429206 ; Device Reference Number AB6220, GTIN 3600040144046, Lot Numbers: 8460192, 8529285; Device Reference Number AB6222, GTIN 3600040144091, Lot Numbers: 8442243, 8459924, 8529346, 8592925, 8806400; Device Reference Number AB6224, GTIN 3600040144145, Lot Numbers: 8442214, 8559578, 9112300 ; Device Reference Number AB6318, GTIN 3600040144190, Lot Numbers: 7637490, 7670546, 8484834, 8498250, 8529294, 8529295 ; Device Reference Number AB6320, GTIN 3600040144329, Lot Numbers: 7416561, 8030228, 8268284, 8296927, 8296928, 8296931, 8296942, 8296955, 8484916, 8691201, 8749915, 9008517, 9008535, 9067831, 9090787, 9112219, 9122900, 9304719, 9341183, 9341188, 9362273, 9374219, 9374226, 9396727, 9396729, 9396730, 9420755, 9420756, 9429254, 9445832, 9445833, 9453638, 9472408, 9498273, 9530041, 9553590, 9792275; Device Reference Number AB6322, GTIN 3600040144459, Lot Numbers: 7338758, 7350593, 7713988, 7727275, 7727278, 7968373, 7977166, 7998276, 8008140, 8087091, 8255376, 8385860, 8506852, 8572895, 8749880, 8884710, 8931589, 8948207, 9031577, 9055067, 9077790, 9102922, 9282729, 9316049, 9342015, 9390309, 9863033, 9888907, 9899174, 9920693, 9920694; Device Reference Number AB6324, GTIN 3600040144589, Lot Numbers: 7161442, 7187947, 7427129, 7494289, 7704381, 7727266, 7959383, 7959384, 7959385, 8008223, 8097934, 8097935, 8097937, 8341187, 8484780, 8484784, 8519827, 8608136, 8742649, 8884484, 8884485, 8923570, 8923572, 9008605, 9053873, 9102865, 9132280, 9261342, 9342043, 9342044, 9375106, 9429327, 9553583, 9571012, 9666667, 9683032; Device Reference Number AB6418, GTIN 3600040144718, Lot Numbers: 8679531; Device Reference Number AB6420, GTIN 3600040144787, Lot Numbers: 8749847; Device Reference Number AB6422, GTIN 3600040144855, Lot Numbers: 8030359, 9192331, 9404762; Device Reference Number AB6424, GTIN 3600040144923, Lot Numbers: 8050720, 9053872, 9843641 ; Device Reference Number AB6522, GTIN 3600040145135, Lot Numbers: 9700704; Device Reference Number AB6524, GTIN 3600040145203, Lot Numbers: 7606773; Device Reference Number AB6A18, GTIN 3600040145838, Lot Numbers: 7387183, 7416523, 7447569, 7504520, 7969002, 8484935, 8593017, 8691164, 8839744, 8865285, 8884610, 8996730, 9090499, 9090500, 9201866, 9201868, 9351867, 9351868, 9778587, 9888888; Device Reference Number AB6A20, GTIN 3600040145906, Lot Numbers: 7187871, 7238887, 7326866, 7405932, 7487264, 7646979, 7646980, 7694201, 8519729, 8519730, 8592981, 8656316, 8749861, 8765663, 8829366, 8853825, 8865362, 8911324, 8911325, 8931643, 8997524, 8997525, 9031251, 9159893, 9159894, 9177746, 9351843, 9362261, 9374229, 9419454, 9445814, 9472372, 9540992, 9558678, 9558679, 9558680 ; Device Reference Number AB6A22, GTIN 3600040145975, Lot Numbers: 7171321, 7290540, 7338690, 7350471, 7440879, 7469993, 7469995, 7469996, 7504590, 7516900, 7680717, 7694159, 7773602, 7810082, 7948506, 7968353, 7998159, 8008112, 8008113, 8097918, 8111866, 8289277, 8289280, 8289282, 8459856, 8529306, 8529307, 8529308, 8608132, 8765655, 8806462, 8839832, 8839833, 8839835, 8865393, 8865394, 8923543, 8923544, 8996594, 8996596, 9008485, 9019036, 9031180, 9031191, 9055054, 9201841, 9240207, 9282369, 9294592, 9461963, 9461964, 9472329, 9505126, 9558646, 9817372, 9829430, 9849265 ; Device Reference Number AB6A24, GTIN 3600040146040, Lot Numbers: 7362278, 7362280, 7387201, 7469990, 7504565, 7694210, 7714088, 8111864, 8255345, 8350315, 8498243, 8603744, 8742657, 8765683, 8853712, 8865439, 9031093, 9041479, 9159898, 9177566, 9374196, 9374197, 9385383, 9446056, 9937345 ; Device Reference Number AB6C18, GTIN 3600040146316, Lot Numbers: 8418135, 9683014 ; Device Reference Number AB6C20, GTIN 3600040146361, Lot Numbers:7908260, 8268412, 8350306, 8408126, 8529315 ; Device Reference Number AB6C22, GTIN 3600040146415, Lot Numbers: 8559519, 8619991, 8656312, 8691203, 8829379, 9018625, 9141394, 9374181 ; Device Reference Number AB6C24, GTIN 3600040146460, Lot Numbers: 9634480; | 36,369 units |
What to do — step by step
Check Product Details
Review the device reference numbers and lot numbers on your catheter to determine if it is recalled.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “US Nationwide. Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 51 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have a recalled catheter?
Contact Coloplast directly to confirm if your catheter is affected and follow their instructions for next steps.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0845-2025 (December 2, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0845-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.