Lower risk Medical device recall · FDA · Published September 10, 2025

Abbott TactiFlex Sensor Catheter Recall: Tip Detachment Risk

Abbott recalls specific TactiFlex Sensor Enabled Ablation Catheters due to limited tip detachment events during removal from packaging. Affected units have unique batch numbers and GTIN.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0112-2026Medical device Abbott ›

Lower-risk recall

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

Take action

Contact the company

Recalling firmAbbott5050 Nathan Ln N · Plymouth, MN 55442-3209

✎ GovInfoNow plain-language explainer

Abbott is recalling certain TactiFlex Sensor Enabled Ablation Catheters because a small number of these devices have experienced tip detachment during removal from packaging. This could potentially cause injury if the catheter becomes dislodged during medical procedures. Read more at govinfonow.com/recall/51359-abbott-tactiflex-sensor-catheter-recall-tip-detachment-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/51359-abbott-tactiflex-sensor-catheter-recall-tip-detachment-risk · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0112-2026

Cite this page

“Abbott TactiFlex Sensor Catheter Recall: Tip Detachment Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51359-abbott-tactiflex-sensor-catheter-recall-tip-detachment-risk. Based on FDA recall #Z-0112-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0112-2026%22&limit=1).

The FDA announced on September 10, 2025, that Abbott is recalling TactiFlex Sensor Enabled Ablation Catheters due to a risk of tip detachment during removal from packaging. The agency issued the voluntary Class I recall affecting approximately 11,810 units distributed worldwide.

How to tell if you have it

Brand: Abbott
Product: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
UPC: 05415067034618
GTIN: 05415067034618
Units affected: 11,810

The hazard

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. The recall is classified as Class I, indicating a situation where use could cause serious adverse health consequences or death.

Context

GovInfoNow's records show Abbott has 12 other recalls on record since April 5, 2018. Other recent recalls of similar products include the Abbott Amplatzer TorqVue LP Catheter Recall (March 17, 2025), the Abbott NT2000iX RF Generator Recall (September 28, 2023), and the Abbott Amplatzer Steerable Delivery Sheath Recall (June 12, 2023). Other recent recalls of similar products include the Medtronic Harmony Catheter System Recall (May 22, 2026), the Medline Intermittent Latex Catheter Recall (May 4, 2026), and the Boston Scientific Imager II Angiographic Catheters Recall (August 24, 2026).

How to tell if you have this one

Check for the product name 'TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ'. Affected units have specific batch numbers listed in the recall notice.

Brand
Abbott
Product
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Category
Medical device

FDA recall event · 5 products

All 5 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 I
Status
Ongoing
Distribution
Worldwide

Recall number	Product, codes & lots	Quantity
Z-0109-2026	TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter; GTIN 05415067034656, Batch Numbers: 8894231, 8915981, 9029640, 9255006, 10001631, 10053399, 10103653, 10120408, 10151069, 10194386, 10194388, 10217380, 10389653, 10429584, 10440518, 10513213, 10513225, 10513232, 10513235, 10551326, 10562041, 10562047, 10562049, 10566077, 10597231, 10597242, 10597249, 10597260, 10613572, 10613581, 10613583, 10613585, 10632079, 10632621, 10632626, 10632634, 10646249, 10673011, 10675350, 10676858, 10677749, 10680007, 10757210, 10785266, 10798695, 10798697, 10816723, 10817847, 10817849, 10850906, 10850907, 10858157, 10858160, 10860077, 10871703, 10885761, 10885921, 10889919, 10892126, 10896652, 10898353, 10899933, 10900171, 10903297, 10903302, 10909596, 10910449, 10910454, 10913639, 10914972, 10917505, 10918937, 10922625, 10922639, 10928017, 10938688, 10939318, 10939319, 10939322, 10950790, 10954012, 10954308, 10954309, 10956216, 10956223, 10957148, 10960327, 10960343, 10961378, 10962731, 10956836, 10958929, 10984316, 10984788, 10985584, 10987173, 11076153, 10984516, 10985598, 10962737.	407 units
Z-0110-2026	TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter; GTIN 05415067034557, Batch Numbers: 8843948, 8855039, 8906316, 8913730, 8921154, 8922146, 8933195, 8947323, 8949324, 8958968, 8959452, 8960986, 8961409, 8963254, 8965484, 8965486, 8991236, 8993365, 9001917, 9003044, 9003047, 9012222, 9013428, 9015293, 9038354, 9039239, 9065946, 9066884, 9071294, 9119487, 9138236, 9147733, 9148411, 9156153, 9158891, 10162247, 10173398, 10205310, 10207502, 10218030, 10228449, 10228450, 10230429, 10232940, 10235434, 10235436, 10240235, 10242138, 10242992, 10242995, 10280672, 10288053, 10288057, 10289553, 10289668, 10289709, 10289759, 10297899, 10334695, 10334845, 10338853, 10338856, 10343551, 10360411, 10375524, 10382430, 10384530, 10384531, 10395601, 10395605, 10449220, 10451314, 10451768, 10451769, 10458698, 10465076, 10465083, 10465086, 10466761, 10469707, 10509213, 10565373, 10565827, 10566663, 10599493, 10600697, 10601488, 10610624, 10615028, 10628998, 10629000, 10638074, 10638488, 10639808, 10641833, 10645657, 10651462, 10651463, 10652440, 10657253, 10696081, 10696560, 10696907, 10705798, 10737121, 10737122, 10737249, 10737251, 10741862, 10742337, 10742342, 10744906, 10748214, 10748215, 10748680, 10749783, 10749788, 10749790, 10763049, 10763071, 10765654, 10780658, 10780710, 10781495, 10781677, 10788527, 10792081, 10792406, 10792407, 10793780, 10799615, 10799616, 10805125, 10805367, 10805369, 10805370, 10805371, 10813353, 10834650, 10844788, 10850740, 10850746, 10851557, 10855920, 10855921, 10868920, 10868921, 10893531, 10978587, 10978588, 11017094, 11017095, 11034753.	3404 units
Z-0111-2026	TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter; GTIN 05415067034571, Batch Numbers: 8707463, 8728375, 8848814, 8849428, 8856153, 8859777, 8930724, 8948407, 9085267, 9134878, 9139151, 9151701, 9154571, 9170156, 9172378, 9202684, 10005870, 10014420, 10014422, 10035838, 10060049, 10067495, 10074488, 10093061, 10095119, 10133240, 10143719, 10146336, 10150246, 10150248, 10158750, 10163256, 10168649, 10175479, 10191672, 10206135, 10219459, 10246287, 10250075, 10259721, 10266993, 10268128, 10278549, 10278947, 10278998, 10279023, 10279962, 10282364, 10284613, 10286135, 10299761, 10301720, 10301724, 10302971, 10310965, 10313193, 10321650, 10321684, 10330213, 10334312, 10337388, 10343800, 10346421, 10347095, 10350600, 10356054, 10356057, 10358260, 10358261, 10358263, 10358912, 10359408, 10359726, 10364782, 10368136, 10369950, 10373269, 10383386, 10392552, 10398359, 10399262, 10399266, 10401107, 10401352, 10405601, 10406221, 10413503, 10419427, 10420466, 10423182, 10424553, 10429934, 10433340, 10441923, 10442325, 10446371, 10466941, 10467483, 10472548, 10482323, 10486432, 10486543, 10487677, 10488850, 10491456, 10492740, 10492927, 10496142, 10496743, 10498367, 10500724, 10501641, 10504231, 10506843, 10506857, 10507585, 10508992, 10509062, 10509063, 10514720, 10520904, 10520905, 10522288, 10523178, 10530261, 10531569, 10531637, 10532991, 10534332, 10534333, 10534886, 10535195, 10536214, 10536994, 10537319, 10537748, 10541506, 10543275, 10543815, 10543854, 10543855, 10545989, 10545990, 10545991, 10546398, 10546400, 10546436, 10547866, 10547867, 10548346, 10548347, 10548419, 10548566, 10548571, 10548665, 10548683, 10549534, 10549536, 10549538, 10549540, 10549547, 10551376, 10551377, 10551730, 10551919, 10552509, 10552510, 10552511, 10552513, 10553135, 10553138, 10553214, 10553267, 10553274, 10554299, 10554300, 10554302, 10555122, 10555128, 10555130, 10555405, 10555460, 10555535, 10555538, 10556436, 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10611688, 10611689, 10611807, 10611820, 10611824, 10612667, 10612673, 10612677, 10612689, 10613757, 10613758, 10613759, 10613760, 10614526, 10614527, 10614594, 10614974, 10615653, 10615659, 10615662, 10615667, 10616244, 10616327, 10616378, 10616449, 10617943, 10617944, 10617966, 10618036, 10618042, 10619157, 10619720, 10619722, 10619723, 10619726, 10620072, 10620343, 10620380, 10620382, 10620384, 10621177, 10622142, 10622171, 10622174, 10622379, 10622383, 10622387, 10622932, 10622943, 10622945, 10623968, 10623980, 10623982, 10623984, 10624282, 10624283, 10624292, 10625734, 10625749, 10625770, 10625771, 10625772, 10625776, 10626594, 10626680, 10626685, 10626714, 10627244, 10627245, 10627246, 10627448, 10627753, 10627905, 10628082, 10628085, 10628383, 10628384, 10628385, 10628429, 10628431, 10628432, 10628494, 10628662, 10628664, 10628992, 10629005, 10629006, 10629012, 10629013, 10629536, 10629537, 10629538, 10629539, 10629541, 10630353, 10630355, 10630376, 10630379, 10630671, 10630675, 10630691, 10632078, 10632081, 10633152, 10634819, 10634825, 10634837, 10634964, 10634965, 10634971, 10635933, 10635936, 10636855, 10636856, 10636858, 10637043, 10638434, 10638586, 10638590, 10638592, 10639378, 10639791, 10639793, 10639868, 10639869, 10639870, 10639871, 10640207, 10640208, 10640209, 10640721, 10641066, 10641073, 10641743, 10641829, 10641830, 10641831, 10641832, 10641861, 10641862, 10641863, 10641864, 10641865, 10641866, 10642333, 10642338, 10642346, 10642351, 10642360, 10642363, 10643852, 10644603, 10644605, 10644607, 10644609, 10644684, 10644685, 10644691, 10644692, 10646419, 10646423, 10646424, 10646427, 10646433, 10647603, 10647614, 10648106, 10648107, 10648134, 10648559, 10648567, 10648570, 10649246, 10649309, 10649323, 10649753, 10649799, 10649823, 10650290, 10650294, 10650298, 10650299, 10650803, 10651083, 10651397, 10651401, 10651456, 10651457, 10651458, 10651459, 10651460, 10651461, 10652405, 10652437, 10652977, 10652989, 10652999, 10653003, 10653482, 10653483, 10653529, 10653530, 10654029, 10654032, 10654053, 10654921, 10654923, 10655172, 10655173, 10655908, 10655909, 10655912, 10656065, 10656371, 10657027, 10657028, 10657029, 10657030, 10657031, 10657034, 10657035, 10657036, 10657037, 10657038, 10661441, 10661448, 10661476, 10661486, 10661488, 10661901, 10661904, 10661905, 10662840, 10662841, 10662842, 10663299, 10663311, 10663620, 10663623, 10663959, 10664390, 10664399, 10665631, 10666119, 10666120, 10666138, 10666572, 10666574, 10667229, 10667574, 10668063, 10668064, 10668073, 10668083, 10668538, 10668541, 10668544, 10669753, 10669943, 10670578, 10670579, 10670601, 10670687, 10670688, 10670689, 10671524, 10671612, 10672174, 10672930, 10672931, 10674543, 10674545, 10674917, 10674918, 10675328, 10675348, 10675349, 10675536, 10675543, 10677120, 10677713, 10677732, 10677736, 10677750, 10678785, 10679336, 10679337, 10680005, 10680042, 10680046, 10680055, 10680945, 10680958, 10681480, 10681706, 10681716, 10682045, 10682047, 10682077, 10682079, 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10821701, 10821717, 10821736, 10821757, 10821760, 10821764, 10823297, 10826283, 10826285, 10826287, 10826290, 10826294, 10827674, 10827712, 10828234, 10829264, 10829269, 10829278, 10829294, 10829987, 10830239, 10830240, 10830736, 10830747, 10830750, 10831489, 10831495, 10832037, 10832448, 10832449, 10832719, 10832722, 10832725, 10835179, 10835183, 10835196, 10835667, 10835670, 10836488, 10836496, 10836658, 10836813, 10836815, 10837556, 10837563, 10838806, 10839384, 10839385, 10839927, 10839938, 10839944, 10839955, 10840895, 10840901, 10841212, 10841299, 10841443, 10841444, 10841455, 10841677, 10841678, 10842942, 10842943, 10842967, 10845196, 10845197, 10845234, 10846549, 10846554, 10846563, 10846564, 10846767, 10847354, 10847357, 10847682, 10847705, 10849125, 10849190, 10849536, 10850763, 10851264, 10851568, 10852060, 10852061, 10852062, 10852063, 10852064, 10852658, 10852842, 10853122, 10853125, 10853138, 10853141, 10853858, 10853860, 10854130, 10854131, 10854675, 10854683, 10854685, 10854686, 10855393, 10855400, 10855891, 10855899, 10855901, 10856808, 10856822, 10856837, 10858167, 10858169, 10858238, 10858239, 10859028, 10859031, 10859033, 10859035, 10859410, 10859411, 10861206, 10861209, 10861424, 10861874, 10861918, 10862062, 10862067, 10862068, 10862627, 10862628, 10863237, 10863238, 10863240, 10863242, 10864214, 10864215, 10865170, 10865171, 10865172, 10865620, 10865642, 10865668, 10866454, 10866738, 10867277, 10867278, 10867480, 10868572, 10868707, 10868713, 10868720, 10869253, 10869254, 10869312, 10869313, 10869314, 10870609, 10871516, 10871517, 10871951, 10872440, 10872451, 10872457, 10872462, 10873320, 10873588, 10874440, 10874606, 10874607, 10874608, 10874841, 10875682, 10875774, 10876024, 10876619, 10876752, 10877183, 10877186, 10877188, 10877717, 10877897, 10877898, 10878045, 10878047, 10879001, 10879013, 10879033, 10879154, 10879155, 10879282, 10879291, 10879360, 10879361, 10879788, 10879792, 10879793, 10879794, 10879795, 10879955, 10880168, 10880246, 10880526, 10880600, 10880604, 10881241, 10881255, 10881259, 10881880, 10883053, 10883054, 10883159, 10883160, 10883161, 10883162, 10883163, 10883489, 10883506, 10883511, 10883513, 10883533, 10883534, 10883932, 10884122, 10884842, 10884848, 10884851, 10884854, 10885202, 10885322, 10885414, 10886685, 10886686, 10886988, 10887209, 10887210, 10887604, 10887613, 10887893, 10888239, 10888242, 10888245, 10888248, 10888249, 10888376, 10889892, 10889897, 10889905, 10889906, 10889918, 10891017, 10891384, 10891385, 10891835, 10891838, 10891841, 10891842, 10891843, 10892136, 10893482, 10893517, 10893792, 10894256, 10894257, 10894262, 10895282, 10895584, 10895987, 10896516, 10896520, 10896521, 10896528, 10896642, 10897740, 10898049, 10898050, 10898356, 10898379, 10898382, 10898383, 10898388, 10899501, 10899630, 10899759, 10900117, 10900148, 10900878, 10900882, 10900883, 10900894, 10901686, 10902701, 10903235, 10903236, 10903298, 10903558, 10903594, 10903596, 10903599, 10905232, 10905530, 10905531, 10905837, 10905913, 10907273, 10907607, 10907692, 10907781, 10907784, 10908110, 10908132, 10908136, 10909351, 10909433, 10909736, 10910216, 10910218, 10910219, 10911335, 10911621, 10911622, 10911834, 10912262, 10912317, 10912338, 10912343, 10912346, 10913976, 10914408, 10915225, 10915233, 10915432, 10916274, 10916582, 10916632, 10916634, 10917113, 10917117, 10917497, 10918452, 10918598, 10918928, 10918929, 10918933, 10918935, 10918936, 10919305, 10920414, 10920415, 10920730, 10920733, 10920745, 10920749, 10920753, 10920760, 10922124, 10922133, 10922137, 10922140, 10922195, 10922626, 10922627, 10922657, 10922665, 10923469, 10923716, 10923725, 10924605, 10924800, 10925028, 10925517, 10925520, 10925523, 10926195, 10926209, 10926880, 10926887, 10927311, 10927712, 10927714, 10927716, 10928060, 10928082, 10929377, 10929442, 10929556, 10929638, 10929640, 10930150, 10930153, 10930158, 10930915, 10930922, 10931383, 10931713, 10931714, 10931715, 10931716, 10931721, 10931722, 10932030, 10932035, 10932036, 10932393, 10932396, 10932400, 10933111, 10933117, 10933156, 10933222, 10933362, 10933490, 10933494, 10933519, 10933521, 10934160, 10934168, 10934169, 10934171, 10935608, 10936802, 10936804, 10936805, 10936811, 10938514, 10938632, 10938633, 10939030, 10939035, 10939180, 10939181, 10939182, 10939804, 10940144, 10940342, 10940343, 10940344, 10940345, 10940635, 10940649, 10940882, 10941309, 10941318, 10941321, 10941326, 10941566, 10950008, 10950024, 10950029, 10950031, 10950034, 10950037, 10951563, 10952564, 10952603, 10952604, 10952606, 10952608, 10954015, 10954508, 10954512, 10955717, 10956012, 10956522, 10956529, 10956530, 10957750, 10957999, 10958001, 10958136, 10958353, 10959352, 10959420, 10960185, 10962662, 10963003, 10963004, 10963432, 10963444, 10963446, 10963449, 10964882, 10964894, 10965222, 10965283, 10965293, 10965758, 10965762, 10967070, 10967383, 10967600, 10967639, 10968757, 10970143, 10972851, 10974662, 10976788, 10976802, 10978489, 10978490, 10978491, 10978492, 10978493, 10985515, 10987787, 11001366, 11001367, 11001368, 11008425, 11022729, 10917114, 10918927, 10922128, 10923747, 10932034, 10936492, 10936499, 10938539, 10941086, 10941569, 10952592, 10954107, 10954511, 10958355, 10959849, 10959850, 10967027, 10967028, 10967388, 10968503, 10968505, 10968738, 10969028, 10970142, 10970338, 10970349, 10970358, 10972424, 10972425, 10972426, 10972427, 10972849, 10972861, 10972865, 10974479, 10974480, 10974665, 10974681, 10976227, 10976255, 10976474, 10976778, 10976807, 10976987, 10978136, 10978678, 10978683, 10980067, 10980199, 10980898, 10983203, 10983441, 10983449, 10983892, 10985075, 10985378, 10985509, 10987475, 10988895, 10989409, 10990012, 10990076, 10990758, 10991009, 10993347, 10993686, 11037069, 11047469, 11047470, 11047471, 11065005, 11065006, 11065007, 11065008, 11065009, 11065010, 11065011, 11065012, 11071628, 10965759, 10972864, 10974062, 10976804, 10978680, 10978681, 10980198, 10980889, 10982507, 10983202, 10983426, 10986129, 10989279, 10989392, 10990760, 10990761, 10992107, 10993351, 10952598, 10965387, 10965405, 10966225, 10972964, 10974066, 10978510, 10980893, 10980895, 10985076, 10970654, 10970670, 10985073, 10987683.	85803 units
Z-0112-2026	TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter; GTIN 05415067034618, Batch Numbers: 10093213, 10093588, 10095366, 10096269, 10118676, 10131389, 10151333, 10180969, 10286877, 10315661, 10317649, 10329929, 10332297, 10344177, 10350400, 10360030, 10374171, 10375844, 10418954, 10431765, 10433617, 10450462, 10492093, 10494298, 10537000, 10537747, 10538321, 10557710, 10557878, 10558450, 10559655, 10569703, 10570507, 10571902, 10571907, 10574230, 10575746, 10575752, 10577567, 10578953, 10579724, 10580699, 10581612, 10581681, 10583203, 10583793, 10587033, 10587043, 10587653, 10589068, 10589921, 10591178, 10591238, 10592227, 10606628, 10606720, 10608438, 10608708, 10611469, 10611683, 10612686, 10614973, 10616329, 10618038, 10619154, 10621180, 10622172, 10622962, 10622967, 10625101, 10630682, 10630687, 10632744, 10633145, 10634830, 10636059, 10637023, 10639373, 10639374, 10639376, 10639377, 10641739, 10641741, 10642345, 10643887, 10644681, 10645838, 10646429, 10648576, 10662844, 10665077, 10666137, 10667210, 10667217, 10668065, 10668185, 10670353, 10670360, 10671604, 10671663, 10672934, 10674544, 10675329, 10675541, 10677719, 10677722, 10678784, 10680052, 10680962, 10684449, 10691502, 10691504, 10691507, 10692805, 10696082, 10696083, 10696084, 10705825, 10708749, 10708800, 10709735, 10711022, 10711803, 10712639, 10712641, 10714607, 10714611, 10715850, 10717049, 10717050, 10719520, 10721238, 10721239, 10725441, 10725442, 10747196, 10749817, 10749820, 10749823, 10751484, 10762186, 10762464, 10764517, 10764523, 10765657, 10766897, 10767820, 10769643, 10770889, 10772623, 10772625, 10773775, 10773811, 10776251, 10777548, 10778157, 10779451, 10808389, 10808390, 10808393, 10811066, 10811067, 10811262, 10821034, 10827717, 10829276, 10829990, 10830744, 10832015, 10832019, 10832727, 10834411, 10834412, 10835187, 10836468, 10836482, 10836911, 10837558, 10837559, 10839959, 10839960, 10841679, 10841690, 10842962, 10845198, 10845199, 10846600, 10847688, 10847695, 10850757, 10850761, 10856004, 10856065, 10858260, 10867490, 10867495, 10868706, 10873737, 10873924, 10875772, 10875773, 10877194, 10897765, 10899500, 10899504, 10902557, 10902569, 10905178, 10905907, 10906368, 10907259, 10909995, 10910050, 10911332, 10911333, 10913977, 10915227, 10915230, 10920111, 10922315, 10922528, 10924643, 10924802, 10927218, 10954504, 10954507, 10955716, 10956520, 10956521, 10958150, 10959364, 10959373, 10960184, 10962699, 10965714, 10970014, 10970054, 10985513, 10989401, 10990017, 10990759, 10992074, 10992078, 10987781.	11810 units
Z-0113-2026	TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter; GTIN 05415067034670, Batch Numbers: 8894357, 8917490, 8984945, 10061309, 10061314, 10061316, 10061317, 10084510, 10084518, 10089968, 10089971, 10099711, 10132013, 10132015, 10132017, 10217367, 10360478, 10360488, 10371567, 10371569, 10371577, 10399929, 10418884, 10418885, 10418895, 10429561, 10429563, 10479188, 10479190, 10482343, 10482351, 10482363, 10482378, 10513080, 10533833, 10533851, 10533854, 10566078, 10597230, 10646250, 10646251, 10646253, 10673213, 10673240, 10684728, 10684732, 10684739, 10684740, 10688513, 10692386, 10695444, 10705803, 10710366, 10713073, 10758992, 10792240, 10792924, 10803221, 10803222, 10812417, 10812431, 10830792, 10830798, 10835329, 10835331, 10861887, 10866457, 10868070, 10870874, 10872753, 10878395, 10878673, 10879391, 10879406, 10978688, 10978690.	1960 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product by checking the batch numbers listed in the recall notice (e.g., 10093213, 10093588, etc.) or the GTIN 05415067034618.

How this recall unfolded

Recall timeline

FDA published this recall 42 days after the firm started it.

Sep 10, 2025Firm started the recall
Oct 10, 2025FDA classified it Class I
Oct 22, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51359-abbott-tactiflex-sensor-catheter-recall-tip-detachment-risk">Abbott TactiFlex Sensor Catheter Recall: Tip Detachment Risk (GovInfoNow)</a>

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-0112-2026 (September 10, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0112-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.