CLASS II ONGOING Device recall · Reported 22 Oct 2025 · FDA Enforcement Report
CX Preconnect with Tenacio Pump with InhibiZone recalled
Boston Scientific is recalling CX Preconnect with Tenacio Pump with InhibiZone, distributed nationwide in the US. The recall was initiated on 11 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0142-2026
- FDA event ID
- 97603
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Sep 2025
- FDA classified
- 10 Oct 2025
- Reported
- 22 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Sep 2025 | Recall initiated by company | |
| 10 Oct 2025 | Classified by FDA | +29 days |
| 22 Oct 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Product as listed by the FDA
CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3) 72404432 (18CM PS IZ), (4) 72404433 (21CM PS IZ), (5) 72404434 (24CM PS IZ), (6) 72404435 (12CM IP IZ), (7) 72404436 (15CM IP IZ), (8) 72404437 (18CM IP IZ), (9) 72404438 (21CM IP IZ), (10) 72404439 (24CM IP IZ);
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Why was it recalled?
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Which lots are affected?
1. UPN: 72404430 (12CM PS IZ); UDI-DI: 00191506021313; Lot numbers: 1100489479, 1100489482, 1100553932, 1100553938, 1100553939, 1100559594, 1100568472, 1100592190, 1100592195, 1100602356, 1100602384, 1100604224, 1100604257, 1100604936, 1100667673, 1100667677, 1100691423, 1100523050, 1100489473, 1100489476, 1100559588, 1100568474, 1100546165, 1100568477, 1100523054, 1100568478, 1100559592, 1100489475, 1100559590, 1100546163, 1100572777, 1100546162, 1100523055, 1100568476, 1100553937, 1100546160, 1100572771, 1100572772, 1100559595, 1100489478, 1100553936, 1100523051, 1100572769, 1100489477, 1100523049, 1100546159, 1100489474, 1100572773, 1100546164, 1100604225, 1100602381, 1100602351, 1100592189, 1100604227, 1100602383, 1100602379, 1100592191, 1100604262, 1100604260, 1100592196, 1100604259, 1100667670, 1100670795, 1100670801, 1100667671, 1100667679, 1100667678, 2. UPN: 72404431 (15CM PS IZ); UDI-DI: 00191506021320; Lot numbers: 1100488945, 1100488946, 1100488947, 1100488951, 1100488952, 1100488953, 1100488954, 1100488981, 1100488982, 1100488983, 1100488984, 1100509688, 1100509689, 1100509690, 1100509693, 1100509694, 1100509695, 1100509706, 1100509711, 1100509714, 1100509716, 1100509717, 1100509719, 1100509724, 1100533744, 1100533745, 1100533749, 1100533751, 1100535545, 1100535546, 1100535552, 1100541422, 1100541423, 1100547735, 1100547736, 1100547738, 1100574742, 1100574743, 1100574747, 1100584464, 1100584466, 1100584467, 1100584468, 1100584470, 1100584471, 1100584472, 1100586699, 1100586701, 1100586702, 1100586705, 1100586706, 1100591067, 1100591068, 1100591069, 1100591073, 1100591074, 1100591075, 1100592675, 1100592682, 1100592683, 1100592684, 1100592704, 1100592705, 1100592708, 1100593462, 1100593464, 1100605249, 1100655173, 1100655178, 1100657280, 1100657281, 1100657282, 1100657287, 1100658348, 1100659230, 1100659238, 1100659642, 1100664225, 1100664227, 1100664240, 1100664242, 1100666373, 1100666379, 1100669912, 1100669913, 1100669914, 1100686427, 1100686429, 1100712803, 1100717712, 1100509718, 1100509709, 1100533742, 1100547739, 1100488985, 1100509705, 1100509710, 1100488986, 1100509691, 1100509715, 1100535551, 1100535550, 1100535549, 1100541426, 1100574748, 1100509723, 1100591070, 1100605251, 1100593460, 1100592680, 1100584473, 1100592677, 1100655175, 1100592702, 1100605253, 1100586704, 1100586707, 1100586703, 1100593467, 1100664223, 1100664237, 1100659649, 1100664235, 1100658342, 1100659641, 1100659233, 1100669911, 1100666376, 1100659640, 1100681641, 1100658340, 1100659648, 1100664239, 1100659234, 1100669910, 1100664224, 1100681636, 1100681640, 1100681637, 1100705558, 1100712802, 1100711033, 1100711021, 1100711030, 1100712801, 3. UPN: 72404432 (18CM PS IZ); UDI-DI: 00191506021337; Lot numbers: 1100479993, 1100479994, 1100479995, 1100479996, 1100479997, 1100479998, 1100479999, 1100480000, 1100480001, 1100480002, 1100480065, 1100480066, 1100480067, 1100480068, 1100480069, 1100480070, 1100480071, 1100480072, 1100480073, 1100480074, 1100489410, 1100489411, 1100489412, 1100489413, 1100489414, 1100489415, 1100489416, 1100489417, 1100489418, 1100489419, 1100512428, 1100512429, 1100512430, 1100512431, 1100512432, 1100512433, 1100512434, 1100512435, 1100512436, 1100512437, 1100523699, 1100523700, 1100523701, 1100523702, 1100523703, 1100523704, 1100523705, 1100523706, 1100523707, 1100523708, 1100527833, 1100527834, 1100527835, 1100527836, 1100527837, 1100527838, 1100527839, 1100527844, 1100527845, 1100527846, 1100527847, 1100527848, 1100527849, 1100527850, 1100527851, 1100528338, 1100528339, 1100528340, 1100528341, 1100528342, 1100528343, 1100528344, 1100528345, 1100528346, 1100528348, 1100528349, 1100528350, 1100528351, 1100528352, 1100528353, 1100528354, 1100528355, 1100528357, 1100533030, 1100533031, 1100533033, 1100533034, 1100533035, 1100533036, 1100533037, 1100533038, 1100555849, 1100555850, 1100555851, 1100555852, 1100555853, 1100555854, 1100555855, 1100555856, 1100555857, 1100555858, 1100558200, 1100558201, 1100558202, 1100558203, 1100558204, 1100558205, 1100558206, 1100558207, 1100558209, 1100563070, 1100563071, 1100563072, 1100563073, 1100563074, 1100573189, 1100573190, 1100573191, 1100573192, 1100573193, 1100573194, 1100573195, 1100573196, 1100573197, 1100576167, 1100576168, 1100576169, 1100576170, 1100576171, 1100576172, 1100576174, 1100578222, 1100578223, 1100578225, 1100578226, 1100578227, 1100578228, 1100578229, 1100578230, 1100578231, 1100578232, 1100578233, 1100578234, 1100578235, 1100578236, 1100578238, 1100578239, 1100578240, 1100578241, 1100578278, 1100578280, 1100578282, 1100578283, 1100578284, 1100578285, 1100578286, 1100578566, 1100578568, 1100578569, 1100578570, 1100578571, 1100578572, 1100578573, 1100578574, 1100578575, 1100582068, 1100582069, 1100582070, 1100582071, 1100582072, 1100582074, 1100582075, 1100582076, 1100582077, 1100590135, 1100590136, 1100590137, 1100590138, 1100590139, 1100590140, 1100590141, 1100590142, 1100590143, 1100590144, 1100590190, 1100590191, 1100590192, 1100590193, 1100590194, 1100590195, 1100590196, 1100590197, 1100590198, 1100590199, 1100590975, 1100590976, 1100590977, 1100590978, 1100590979, 1100590980, 1100590981, 1100590982, 1100590983, 1100590984, 1100591028, 1100591029, 1100591030, 1100591031, 1100591032, 1100591033, 1100591034, 1100591035, 1100591036, 1100592732, 1100592733, 1100592734, 1100592735, 1100592736, 1100592737, 1100592738, 1100592739, 1100592740, 1100597245, 1100597246, 1100597247, 1100597248, 1100597250, 1100597251, 1100597252, 1100597253, 1100598427, 1100598428, 1100598429, 1100598431, 1100598432, 1100598433, 1100598434, 1100614950, 1100614951, 1100614952, 1100614953, 1100614954, 1100614957, 1100614958, 1100614959, 1100615312, 1100615313, 1100615314, 1100615315, 1100615316, 1100615317, 1100615318, 1100615319, 1100615320, 1100615635, 1100615636, 1100615637, 1100615638, 1100615639, 1100615640, 1100615642, 1100617815, 1100617817, 1100617818, 1100617819, 1100617820, 1100617821, 1100617822, 1100617823, 1100622709, 1100622710, 1100622711, 1100622712, 1100622713, 1100622714, 1100622715, 1100622716, 1100622717, 1100623591, 1100623592, 1100623594, 1100623595, 1100628785, 1100628786, 1100628787, 1100628788, 1100628789, 1100628790, 1100628791, 1100628793, 1100628794, 1100632022, 1100632023, 1100632024, 1100632025, 1100632026, 1100632027, 1100632028, 1100632030, 1100651848, 1100651849, 1100651850, 1100651851, 1100651852, 1100651853, 1100651855, 1100652180, 1100652181, 1100652182, 1100652186, 1100652187, 1100652188, 1100652190, 1100652191, 1100652192, 1100652193, 1100652194, 1100655635, 1100655636, 1100655637, 1100655638, 1100655639, 1100655640, 1100655641, 1100655642, 1100655643, 1100655644, 1100657267, 1100657268, 1100657269, 1100657270, 1100657272, 1100657274, 1100657276, 1100658241, 1100658242, 1100658243, 1100658245, 1100658246, 1100658247, 1100658248, 1100658249, 1100662686, 1100662687, 1100662688, 1100662691, 1100662692, 1100662693, 1100662694, 1100662695, 1100662723, 1100662725, 1100662727, 1100662728, 1100662729, 1100663420, 1100663421, 1100663422, 1100663423, 1100664157, 1100664158, 1100664160, 1100664161, 1100664163, 1100664164, 1100664165, 1100664166, 1100664177, 1100664178, 1100664180, 1100664181, 1100664182, 1100664183, 1100664185, 1100664186, 1100665250, 1100665254, 1100665255, 1100673302, 1100673303, 1100673305, 1100673307, 1100673308, 1100673309, 1100673311, 1100675398, 1100675399, 1100675400, 1100675401, 1100675402, 1100675403, 1100675405, 1100675406, 1100676776, 1100676778, 1100676779, 1100676780, 1100676781, 1100676782, 1100681563, 1100681564, 1100681565, 1100681566, 1100681567, 1100681568, 1100681570, 1100681571, 1100681623, 1100681625, 1100681627, 1100681628, 1100681630, 1100687984, 1100687985, 1100687986, 1100687987, 1100687988, 1100687989, 1100687991, 1100687992, 1100687993, 1100688032, 1100688033, 1100688037, 1100688038, 1100688039, 1100688040, 1100688742, 1100688743, 1100688744, 1100688745, 1100688746, 1100688747, 1100688748, 1100688749, 1100688750, 1100688751, 1100688752, 1100688753, 1100688754, 1100688755, 1100688756, 1100688757, 1100688759, 1100688761, 1100693136, 1100697385, 1100697387, 1100697388, 1100697389, 1100697390, 1100697391, 1100697393, 1100698109, 1100698110, 1100698112, 1100698114, 1100698116, 1100698117, 1100710476, 1100710477, 1100710480, 1100710481, 1100710483, 1100710498, 1100710499, 1100720978, 1100720980, 1100720985, 1100720986, 1100721733, 1100721737, 1100721739, 1100721742, 1100722256, 1100722261, 1100722263, 1100722265, 1100755419, 1100755420, 1100755421, 1100755422, 1100755423, 1100755424, 1100755425, 1100755426, 1100755427, 1100755428, 1100528356, 1100558208, 1100533032, 1100578281, 1100578224, 1100614955, 1100598430, 1100615641, 1100651854, 1100652184, 1100651846, 1100617816, 1100651847, 1100632029, 1100652189, 1100628792, 1100652185, 1100652183, 1100665252, 1100693141, 1100675397, 1100688036, 1100662722, 1100688034, 1100681626, 1100676783, 1100662721, 1100681572, 1100688758, 1100662689, 1100693140, 1100693135, 1100698113, 1100662690, 1100688760, 1100688035, 1100693139, 1100658244, 1100681624, 1100702136, 1100665253, 1100687990, 1100675404, 1100665251, 1100664162, 1100721736, 1100722262, 1100710474, 1100710501, 1100709705, 1100710496, 1100710482, 1100722257, 1100710495, 1100722259, 1100720981, 1100708178, 4. UPN: 72404433 (21CM PS IZ); UDI-DI: 00191506021344; Lot numbers: 1100398859, 1100398860, 1100398861, 1100398862, 1100398863, 1100398864, 1100398865, 1100398866, 1100398867, 1100399011, 1100399012, 1100399013, 1100399014, 1100399015, 1100399016, 1100399017, 1100399018, 1100399019, 1100480314, 1100480315, 1100480316, 1100480317, 1100480318, 1100480319, 1100480320, 1100480321, 1100480322, 1100480323, 1100480324, 1100480325, 1100480326, 1100480327, 1100480328, 1100480329, 1100480330, 1100480331, 1100480332, 1100480333, 1100480334, 1100480335, 1100480336, 1100480337, 1100480338, 1100480339, 1100480340, 1100480341, 1100480351, 1100480352, 1100480353, 1100480354, 1100480355, 1100480356, 1100480357, 1100480358, 1100480359, 1100480360, 1100489438, 1100489439, 1100489440, 1100489441, 1100489442, 1100489443, 1100489444, 1100489445, 1100489446, 1100489447, 1100491981, 1100491982, 1100491983, 1100491984, 1100509384, 1100509385, 1100509386, 1100509387, 1100509390, 1100509391, 1100509392, 1100509393, 1100512513, 1100512514, 1100512515, 1100512516, 1100512517, 1100512518, 1100512519, 1100512520, 1100512521, 1100512522, 1100523887, 1100523888, 1100523889, 1100523890, 1100523891, 1100523892, 1100523893, 1100523894, 1100523895, 1100523896, 1100526049, 1100526050, 1100526051, 1100526052, 1100526054, 1100526055, 1100526056, 1100526057, 1100526058, 1100527977, 1100527978, 1100527979, 1100527980, 1100527981, 1100527982, 1100527983, 1100527984, 1100527985, 1100527986, 1100530236, 1100530237, 1100530238, 1100530239, 1100530241, 1100530242, 1100532719, 1100532721, 1100532722, 1100532723, 1100532724, 1100532725, 1100532766, 1100532767, 1100532768, 1100532769, 1100532770, 1100532771, 1100532772, 1100532773, 1100532774, 1100532775, 1100532776, 1100532777, 1100532778, 1100532779, 1100532780, 1100532781, 1100535213, 1100535214, 1100535215, 1100535216, 1100535217, 1100535218, 1100535219, 1100535220, 1100535221, 1100535222, 1100535283, 1100535284, 1100535285, 1100535286, 1100535287, 1100535288, 1100535289, 1100535290, 1100535291, 1100535292, 1100537972, 1100537973, 1100537974, 1100537975, 1100537976, 1100537977, 1100537978, 1100537979, 1100537980, 1100537981, 1100538187, 1100538188, 1100538189, 1100538190, 1100538191, 1100538192, 1100538193, 1100538194, 1100538195, 1100538196, 1100540588, 1100540589, 1100540590, 1100540591, 1100545407, 1100545408, 1100545409, 1100545410, 1100545411, 1100545412, 1100545413, 1100545414, 1100545415, 1100545416, 1100556121, 1100556122, 1100556123, 1100556124, 1100556125, 1100556126, 1100556127, 1100556128, 1100556129, 1100556130, 1100556166, 1100556167, 1100556168, 1100556169, 1100556170, 1100556171, 1100556172, 1100556173, 1100556174, 1100556175, 1100573109, 1100573110, 1100573111, 1100573112, 1100573114, 1100573115, 1100573116, 1100573117, 1100574676, 1100574677, 1100574678, 1100574679, 1100574680, 1100574681, 1100574682, 1100574683, 1100574684, 1100574685, 1100574686, 1100574687, 1100574688, 1100574689, 1100574690, 1100574691, 1100574692, 1100574693, 1100574695, 1100574696, 1100574697, 1100574698, 1100574699, 1100574700, 1100574701, 1100574702, 1100574703, 1100574704, 1100574705, 1100574731, 1100574732, 1100574733, 1100574734, 1100574735, 1100574736, 1100574737, 1100574738, 1100578361, 1100578362, 1100578363, 1100578364, 1100578365, 1100578366, 1100578367, 1100578368, 1100578369, 1100578370, 1100578401, 1100578402, 1100578403, 1100578404, 1100578405, 1100578406, 1100578407, 1100578408, 1100578409, 1100578410, 1100579259, 1100579260, 1100579261, 1100579262, 1100579263, 1100579264, 1100579266, 1100579267, 1100579268, 1100579307, 1100579308, 1100579309, 1100579310, 1100579311, 1100579313, 1100579314, 1100579315, 1100584419, 1100584420, 1100584421, 1100584422, 1100584423, 1100584424, 1100584425, 1100584426, 1100584427, 1100584428, 1100584429, 1100584430, 1100584431, 1100584432, 1100584433, 1100584434, 1100584435, 1100584436, 1100584437, 1100584438, 1100586604, 1100586605, 1100586606, 1100586607, 1100586608, 1100586609, 1100586610, 1100586611, 1100586612, 1100586613, 1100591048, 1100591049, 1100591050, 1100591051, 1100591052, 1100591053, 1100591054, 1100591055, 1100591056, 1100591057, 1100594881, 1100594882, 1100594883, 1100594884, 1100594885, 1100594886, 1100594887, 1100594888, 1100594889, 1100595633, 1100595634, 1100595635, 1100595636, 1100595637, 1100595638, 1100595639, 1100595640, 1100595641, 1100595642, 1100595668, 1100595669, 1100595670, 1100595671, 1100595672, 1100595673, 1100595674, 1100595675, 1100595677, 1100595965, 1100595966, 1100595967, 1100595968, 1100595969, 1100595970, 1100595971, 1100595972, 1100595973, 1100608242, 1100608243, 1100608244, 1100608245, 1100608246, 1100614010, 1100614011, 1100614012, 1100614013, 1100614014, 1100614015, 1100614016, 1100614017, 1100615048, 1100615049, 1100615050, 1100615051, 1100615052, 1100615053, 1100615054, 1100615055, 1100615056, 1100617853, 1100617854, 1100617855, 1100617856, 1100617857, 1100617858, 1100617860, 1100617861, 1100620432, 1100620433, 1100620434, 1100620435, 1100620436, 1100620437, 1100620438, 1100620439, 1100620440, 1100620441, 1100621398, 1100621399, 1100621400, 1100621401, 1100621402, 1100621404, 1100621406, 1100621407, 1100621408, 1100621409, 1100621410, 1100621411, 1100621414, 1100621415, 1100621416, 1100621417, 1100622324, 1100622325, 1100622327, 1100622328, 1100622329, 1100622330, 1100622331, 1100622332, 1100622333, 1100623395, 1100623396, 1100623398, 1100623399, 1100623401, 1100623402, 1100623403, 1100623404, 1100626485, 1100626486, 1100626487, 1100626488, 1100626489, 1100626490, 1100626491, 1100626492, 1100626493, 1100653941, 1100653942, 1100653944, 1100653945, 1100653946, 1100653947, 1100653948, 1100653949, 1100653950, 1100653969, 1100653970, 1100653971, 1100653972, 1100653976, 1100653977, 1100653978, 1100655163, 1100655164, 1100655165, 1100655166, 1100655167, 1100655168, 1100655169, 1100655170, 1100655171, 1100655172, 1100655518, 1100655519, 1100655520, 1100655523, 1100655524, 1100655525, 1100655528, 1100655529, 1100655530, 1100655531, 1100655532, 1100655533, 1100655534, 1100655535, 1100655536, 1100655538, 1100655539, 1100655540, 1100655542, 1100655543, 1100655544, 1100658023, 1100658024, 1100658025, 1100658026, 1100658028, 1100658029, 1100658031, 1100658032, 1100658261, 1100658263, 1100658264, 1100658265, 1100658266, 1100658267, 1100658268, 1100659601, 1100659602, 1100659603, 1100659604, 1100659605, 1100659606, 1100659608, 1100659612, 1100659613, 1100659614, 1100659615, 1100659617, 1100659618, 1100659619, 1100659620, 1100659621, 1100659623, 1100659624, 1100659626, 1100659627, 1100659628, 1100659629, 1100659631, 1100659633, 1100659634, 1100659635, 1100659636, 1100659638, 1100659639, 1100660213, 1100660214, 1100660215, 1100660216, 1100660217, 1100660219, 1100660220, 1100660221, 1100660249, 1100660250, 1100660251, 1100660252, 1100660253, 1100660256, 1100660258, 1100660259, 1100660260, 1100660261, 1100660262, 1100660263, 1100660264, 1100660266, 1100660267, 1100663049, 1100663050, 1100663051, 1100663052, 1100663053, 1100663054, 1100663055, 1100663057, 1100663058, 1100665182, 1100665183, 1100665184, 1100665185, 1100665186, 1100665188, 1100665189, 1100665190, 1100665471, 1100665472, 1100665473, 1100665474, 1100665475, 1100665476, 1100665477, 1100665478, 1100666158, 1100666159, 1100666160, 1100666161, 1100666162, 1100666163, 1100666164, 1100666165, 1100666166, 1100666167, 1100667277, 1100667278, 1100667282, 1100667284, 1100667285, 1100667286, 1100667287, 1100667289, 1100667290, 1100667291, 1100667293, 1100667294, 1100667603, 1100667604, 1100667605, 1100667606, 1100667607, 1100667608, 1100667609, 1100667610, 1100667612, 1100668292, 1100669963, 1100669965, 1100669966, 1100669969, 1100669972, 1100670734, 1100670735, 1100670736, 1100670737, 1100670738, 1100670739, 1100670741, 1100670742, 1100670743, 1100673956, 1100673957, 1100673959, 1100673961, 1100673962, 1100673963, 1100673964, 1100673965, 1100675388, 1100675389, 1100675392, 1100675393, 1100675394, 1100675395, 1100675396, 1100676961, 1100676962, 1100676963, 1100676964, 1100676965, 1100676966, 1100676967, 1100681403, 1100681404, 1100681405, 1100681406, 1100681407, 1100681409, 1100681410, 1100681510, 1100681512, 1100681513, 1100681514, 1100681515, 1100681516, 1100681517, 1100692275, 1100692276, 1100692277, 1100692278, 1100692283, 1100692284, 1100692312, 1100692313, 1100692314, 1100692315, 1100692316, 1100692317, 1100692319, 1100692320, 1100692321, 1100692323, 1100692324, 1100692325, 1100692327, 1100692328, 1100692329, 1100693892, 1100693893, 1100693896, 1100693897, 1100693898, 1100693899, 1100693901, 1100694721, 1100694724, 1100694725, 1100694726, 1100694727, 1100694728, 1100694729, 1100702311, 1100702312, 1100702314, 1100702316, 1100702317, 1100702319, 1100702320, 1100709690, 1100709695, 1100709709, 1100710746, 1100710753, 1100710757, 1100710758, 1100710759, 1100712661, 1100712665, 1100712666, 1100713203, 1100713205, 1100713209, 1100713210, 1100713211, 1100723307, 1100723309, 1100723314, 1100723315, 1100723316, 1100726366, 1100726369, 1100726370, 1100726375, 1100532720, 1100573118, 1100579265, 1100491980, 1100579312, 1100530240, 1100573113, 1100653975, 1100617859, 1100623400, 1100653974, 1100655522, 1100621403, 1100621412, 1100595676, 1100655541, 1100653943, 1100655537, 1100622326, 1100670740, 1100658030, 1100673960, 1100659616, 1100667281, 1100663056, 1100675391, 1100692326, 1100692318, 1100669967, 1100693900, 1100667280, 1100667288, 1100694730, 1100692322, 1100693895, 1100692281, 1100659632, 1100676968, 1100667279, 1100673958, 1100669968, 1100693894, 1100669971, 1100669964, 1100660248, 1100665181, 1100659607, 1100675387, 1100676960, 1100681408, 1100709718, 1100710745, 1100710743, 1100709714, 1100702318, 1100723308, 1100710750, 1100712660, 1100709715, 1100710747, 1100709711, 1100732706, 1100713207, 1100723313, 1100723311, 1100723312, 5. UPN: 72404434 (24CM PS IZ); UDI-DI: 00191506021351; Lot numbers: 1100404841, 1100404842, 1100404843, 1100404845, 1100404846, 1100404847, 1100404848, 1100477638, 1100477639, 1100477640, 1100477645, 1100477646, 1100491851, 1100491853, 1100491855, 1100491856, 1100491857, 1100491858, 1100491860, 1100491871, 1100491873, 1100491875, 1100491878, 1100491880, 1100509760, 1100509761, 1100509762, 1100509765, 1100509768, 1100509769, 1100509770, 1100509773, 1100509775, 1100525451, 1100525452, 1100525453, 1100525455, 1100525457, 1100525458, 1100529589, 1100529591, 1100529594, 1100529596, 1100540597, 1100540599, 1100540600, 1100540601, 1100540602, 1100540603, 1100540604, 1100556285, 1100556286, 1100556287, 1100556289, 1100556290, 1100556292, 1100556445, 1100556446, 1100556447, 1100556450, 1100556451, 1100556452, 1100556718, 1100556719, 1100556720, 1100557301, 1100557303, 1100557304, 1100557305, 1100557306, 1100557308, 1100558477, 1100558481, 1100558484, 1100563642, 1100563643, 1100563644, 1100563646, 1100563648, 1100563650, 1100576003, 1100576004, 1100576005, 1100576009, 1100576010, 1100576011, 1100576012, 1100597147, 1100597148, 1100597149, 1100597151, 1100597153, 1100604264, 1100604265, 1100604270, 1100604271, 1100604272, 1100604273, 1100604274, 1100604275, 1100604276, 1100604279, 1100604282, 1100604284, 1100604285, 1100604286, 1100604290, 1100604293, 1100605225, 1100605226, 1100605230, 1100605231, 1100605233, 1100605234, 1100605236, 1100605239, 1100605241, 1100605242, 1100605243, 1100609900, 1100609901, 1100609902, 1100609903, 1100619616, 1100619617, 1100619618, 1100619620, 1100619622, 1100623375, 1100623376, 1100623377, 1100623380, 1100623382, 1100623383, 1100623603, 1100623607, 1100624278, 1100624279, 1100624280, 1100624282, 1100624283, 1100624284, 1100626379, 1100626380, 1100626381, 1100626382, 1100626386, 1100658076, 1100658077, 1100658081, 1100658082, 1100658153, 1100658155, 1100658158, 1100658159, 1100658162, 1100682726, 1100682729, 1100682732, 1100682733, 1100683460, 1100683462, 1100683465, 1100690141, 1100691010, 1100691013, 1100698164, 1100698172, 1100509774, 1100525459, 1100509758, 1100556717, 1100529593, 1100509757, 1100491876, 1100509767, 1100557302, 1100556716, 1100529592, 1100491872, 1100540596, 1100525450, 1100558485, 1100540605, 1100529595, 1100491874, 1100529590, 1100556284, 1100477643, 1100563649, 1100556448, 1100525454, 1100509776, 1100563647, 1100477641, 1100477642, 1100477644, 1100558480, 1100556449, 1100491854, 1100491877, 1100509763, 1100404844, 1100509764, 1100491852, 1100529598, 1100624285, 1100604269, 1100597150, 1100604289, 1100623602, 1100604291, 1100626378, 1100626383, 1100623381, 1100626384, 1100604277, 1100619619, 1100691017, 1100691019, 1100698166, 1100683463, 1100683458, 1100682725, 1100690134, 1100698163, 1100683459, 1100733032, 1100733035, 1100723233, 1100723237, 6. UPN: 72404435 (12CM IP IZ); UDI-DI: 00191506021368; Lot numbers: 1100556756, 1100562739, 1100492138, 1100570210, 1100570206, 1100570209, 1100480148, 1100480143, 1100576373, 1100480151, 1100492133, 1100492134, 1100492135, 1100556757, 1100492130, 1100559507, 1100556758, 1100572095, 1100576374, 1100480145, 1100480144, 1100492131, 1100480147, 1100492129, 1100559511, 1100559509, 1100492137, 1100480150, 1100492136, 1100480149, 1100562742, 1100584865, 1100584845, 1100584840, 7. UPN: 72404436 (15CM IP IZ); UDI-DI: 00191506021375; Lot numbers: 1100490725, 1100490727, 1100490728, 1100490730, 1100490796, 1100490800, 1100490802, 1100490803, 1100490804, 1100490809, 1100490810, 1100490812, 1100490813, 1100490815, 1100510307, 1100510308, 1100510309, 1100510310, 1100510311, 1100510314, 1100511326, 1100511328, 1100511329, 1100511330, 1100511331, 1100511332, 1100511334, 1100529987, 1100529989, 1100529992, 1100529993, 1100573909, 1100573910, 1100573911, 1100573912, 1100573915, 1100573916, 1100573917, 1100573918, 1100573962, 1100573963, 1100573965, 1100573970, 1100573971, 1100591122, 1100591123, 1100591126, 1100591130, 1100608586, 1100608587, 1100608589, 1100609479, 1100609481, 1100609482, 1100609485, 1100609487, 1100626431, 1100626433, 1100626438, 1100627625, 1100667324, 1100667327, 1100667633, 1100667640, 1100669896, 1100672734, 1100672735, 1100676767, 1100676768, 1100676770, 1100676771, 1100676772, 1100755478, 1100755479, 1100755480, 1100755481, 1100755482, 1100755483, 1100755484, 1100755485, 1100755486, 1100755487, 1100756184, 1100756185, 1100756186, 1100756187, 1100756188, 1100756189, 1100756190, 1100756191, 1100756192, 1100756193, 1100490722, 1100490805, 1100510313, 1100573966, 1100490799, 1100490798, 1100490723, 1100573968, 1100490729, 1100511335, 1100490801, 1100490726, 1100490724, 1100490797, 1100490731, 1100573967, 1100490806, 1100510312, 1100627629, 1100627623, 1100608592, 1100591131, 1100609484, 1100667641, 1100672732, 1100667328, 1100667647, 1100672736, 8. UPN: 72404437 (18CM IP IZ); UDI-DI: 00191506021382; Lot numbers: 1100404804, 1100404805, 1100404806, 1100404807, 1100404808, 1100404809, 1100404810, 1100404811, 1100404812, 1100480258, 1100480260, 1100480261, 1100480263, 1100480264, 1100480265, 1100480266, 1100480267, 1100480286, 1100480287, 1100480288, 1100480289, 1100480290, 1100480291, 1100480292, 1100480293, 1100480294, 1100480295, 1100490852, 1100490853, 1100490854, 1100490855, 1100490856, 1100490857, 1100490858, 1100490859, 1100490860, 1100490861, 1100491398, 1100491399, 1100491400, 1100491401, 1100491402, 1100491403, 1100491404, 1100491405, 1100491406, 1100491407, 1100509557, 1100509558, 1100509559, 1100509560, 1100509561, 1100509562, 1100509563, 1100509564, 1100509566, 1100511277, 1100511278, 1100511279, 1100511280, 1100511281, 1100511282, 1100511283, 1100511284, 1100511285, 1100511286, 1100578557, 1100578558, 1100578559, 1100578560, 1100578561, 1100578562, 1100578565, 1100582058, 1100582060, 1100582061, 1100582062, 1100582063, 1100582064, 1100582065, 1100582066, 1100582067, 1100592712, 1100592713, 1100592714, 1100592715, 1100592716, 1100592717, 1100592719, 1100592720, 1100595604, 1100595605, 1100595606, 1100595607, 1100595608, 1100595609, 1100595610, 1100595611, 1100595612, 1100608252, 1100608254, 1100608256, 1100608257, 1100608258, 1100608259, 1100608260, 1100617834, 1100617835, 1100617837, 1100617838, 1100617839, 1100617840, 1100617841, 1100625079, 1100625080, 1100625081, 1100625082, 1100625083, 1100625084, 1100625085, 1100625086, 1100625087, 1100625088, 1100626505, 1100626506, 1100626509, 1100626510, 1100626511, 1100626512, 1100626513, 1100629386, 1100629387, 1100629389, 1100629392, 1100629393, 1100629394, 1100629395, 1100652235, 1100652238, 1100652239, 1100652240, 1100652241, 1100652242, 1100652243, 1100652244, 1100654680, 1100654682, 1100654683, 1100654684, 1100654685, 1100655683, 1100655684, 1100655685, 1100655687, 1100657546, 1100657548, 1100657549, 1100657550, 1100657551, 1100657552, 1100657553, 1100657554, 1100660305, 1100660306, 1100660308, 1100660309, 1100660310, 1100660311, 1100662676, 1100662677, 1100662678, 1100662680, 1100662682, 1100662683, 1100662684, 1100662685, 1100662758, 1100662760, 1100662765, 1100663409, 1100663412, 1100663413, 1100663415, 1100663416, 1100664169, 1100664170, 1100664173, 1100664174, 1100664175, 1100676796, 1100676798, 1100676799, 1100676800, 1100676802, 1100676803, 1100676804, 1100676805, 1100697420, 1100697421, 1100697423, 1100697425, 1100697426, 1100702534, 1100702535, 1100702537, 1100721026, 1100721028, 1100721031, 1100755960, 1100755961, 1100755962, 1100755963, 1100755964, 1100755965, 1100509565, 1100654679, 1100655686, 1100654681, 1100626508, 1100626514, 1100629391, 1100629390, 1100592711, 1100595613, 1100582059, 1100592718, 1100662681, 1100660307, 1100676801, 1100662679, 1100676797, 1100660304, 1100664172, 1100662762, 1100663414, 1100721030, 1100702533, 1100721027, 1100702530, 1100702532, 9. UPN: 72404438 (21CM IP IZ); UDI-DI: 00191506021399; Lot numbers: 1100399001, 1100399002, 1100399003, 1100399004, 1100399005, 1100399006, 1100399007, 1100399008, 1100399009, 1100399010, 1100480612, 1100480613, 1100480614, 1100480615, 1100480616, 1100480618, 1100480619, 1100480620, 1100480621, 1100481570, 1100481571, 1100481572, 1100481573, 1100481574, 1100481575, 1100481576, 1100481577, 1100483215, 1100483216, 1100483217, 1100483218, 1100483219, 1100483220, 1100483221, 1100483222, 1100483223, 1100509468, 1100509469, 1100509470, 1100509471, 1100509472, 1100509473, 1100509474, 1100509475, 1100509485, 1100509486, 1100509487, 1100509488, 1100509489, 1100509490, 1100509491, 1100509492, 1100509493, 1100509529, 1100509530, 1100509531, 1100509532, 1100509533, 1100509534, 1100509535, 1100509536, 1100509537, 1100509538, 1100522035, 1100522036, 1100522037, 1100522038, 1100522039, 1100522040, 1100522041, 1100522042, 1100522043, 1100522044, 1100540606, 1100540607, 1100540608, 1100540609, 1100540610, 1100540611, 1100540612, 1100540613, 1100578391, 1100578392, 1100578393, 1100578394, 1100578395, 1100578396, 1100578397, 1100578398, 1100578399, 1100578400, 1100582121, 1100582122, 1100582123, 1100582124, 1100582125, 1100582126, 1100582127, 1100582128, 1100582129, 1100582130, 1100584349, 1100584350, 1100584351, 1100584352, 1100584354, 1100584355, 1100584357, 1100584358, 1100584904, 1100584905, 1100584906, 1100584907, 1100584908, 1100584909, 1100584910, 1100584911, 1100584912, 1100584913, 1100584934, 1100584935, 1100584936, 1100584937, 1100584938, 1100584939, 1100584940, 1100584941, 1100584942, 1100584943, 1100589998, 1100589999, 1100590000, 1100590001, 1100590003, 1100590005, 1100590006, 1100590007, 1100613893, 1100613894, 1100613895, 1100613896, 1100613897, 1100613898, 1100613899, 1100613900, 1100613901, 1100613902, 1100617890, 1100617891, 1100617893, 1100617895, 1100617897, 1100617898, 1100617899, 1100618997, 1100618998, 1100618999, 1100619000, 1100619001, 1100619003, 1100619004, 1100619005, 1100619006, 1100622334, 1100622335, 1100622336, 1100622337, 1100622338, 1100622339, 1100622341, 1100622342, 1100625099, 1100625100, 1100625101, 1100625102, 1100625104, 1100625106, 1100625107, 1100625108, 1100630645, 1100630646, 1100630647, 1100630648, 1100630649, 1100630650, 1100630651, 1100630652, 1100630653, 1100632103, 1100632104, 1100632105, 1100632106, 1100632107, 1100632108, 1100636846, 1100636847, 1100636849, 1100636851, 1100636852, 1100636853, 1100636854, 1100636855, 1100636876, 1100636877, 1100636878, 1100636879, 1100636880, 1100636882, 1100636883, 1100636884, 1100657390, 1100657391, 1100657393, 1100657394, 1100657399, 1100658033, 1100658034, 1100658035, 1100658036, 1100658037, 1100658038, 1100658039, 1100658041, 1100658042, 1100658921, 1100658922, 1100658923, 1100658924, 1100658925, 1100658926, 1100658927, 1100658928, 1100672665, 1100672666, 1100672667, 1100672670, 1100672672, 1100672673, 1100675958, 1100675964, 1100675967, 1100676951, 1100676952, 1100676953, 1100676954, 1100676955, 1100676956, 1100676957, 1100677576, 1100677577, 1100677578, 1100677580, 1100677582, 1100677583, 1100677584, 1100684979, 1100684980, 1100684981, 1100684984, 1100684985, 1100684986, 1100684987, 1100695734, 1100695738, 1100695739, 1100695741, 1100698582, 1100755429, 1100755430, 1100755431, 1100755432, 1100755433, 1100755434, 1100755435, 1100755436, 1100755437, 1100483214, 1100480617, 1100584353, 1100636881, 1100617896, 1100590004, 1100590002, 1100619002, 1100625103, 1100658929, 1100657398, 1100695736, 1100684983, 1100657396, 1100675959, 1100698581, 1100672671, 1100695740, 1100698578, 1100716476, 10. UPN: 72404439 (24CM IP IZ); UDI-DI: 00191506021405; Lot numbers: 1100398922, 1100398924, 1100398926, 1100398927, 1100398928, 1100398929, 1100398930, 1100491865, 1100491866, 1100491868, 1100492099, 1100492100, 1100492101, 1100509782, 1100509786, 1100509787, 1100509788, 1100509791, 1100511268, 1100511276, 1100557385, 1100557387, 1100559426, 1100559429, 1100571285, 1100571287, 1100571290, 1100571291, 1100572297, 1100572298, 1100576051, 1100576053, 1100576056, 1100576057, 1100576058, 1100576059, 1100579707, 1100579711, 1100579712, 1100579713, 1100579716, 1100585009, 1100585012, 1100585014, 1100595679, 1100595684, 1100595685, 1100595686, 1100595687, 1100606722, 1100606723, 1100606725, 1100606726, 1100624252, 1100624254, 1100624255, 1100624256, 1100624257, 1100624259, 1100673252, 1100673978, 1100673981, 1100675235, 1100675242, 1100398921, 1100571284, 1100492098, 1100557384, 1100491862, 1100509783, 1100511271, 1100492095, 1100509789, 1100572296, 1100492097, 1100491870, 1100491867, 1100511269, 1100398923, 1100491861, 1100398925, 1100576060, 1100511274, 1100509790, 1100491869, 1100572295, 1100571289, 1100511270, 1100492096, 1100557388, 1100576054, 1100509784, 1100509785, 1100572302, 1100585013, 1100585016, 1100579710, 1100595678, 1100585008, 1100606727, 1100595683, 1100585015, 1100579708, 1100624253, 1100595681, 1100673984, 1100675237, 1100673983, 1100669362, 1100675238, 1100669359;
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
6 other products · FDA event 97603This product is part of a recall event; the main page for the event is Tenacio Pump without InhibiZone recalled by Boston Scientific.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Tenacio Pump without InhibiZone recalled by Boston Scientific | Boston Scientific | Other | Nationwide | |
| CLASS II | Tenacio Pump with InhibiZone recalled by Boston Scientific | Boston Scientific | Other | Nationwide | |
| CLASS II | LGX Preconnect with Tenacio Pump without InhibiZone recalled | Boston Scientific | Other | Nationwide | |
| CLASS II | CXR Preconnect with Tenacio Pump with InhibiZone recalled | Boston Scientific | Other | Nationwide | |
| CLASS II | CX Preconnect with Tenacio Pump without InhibiZone recalled | Boston Scientific | Other | Nationwide | |
| CLASS II | LGX Preconnect with Tenacio Pump with InhibiZone recalled | Boston Scientific | Other | Nationwide |
More recalls from Boston Scientific
All 626| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS I | Enroute Transcarotid Neuroprotection System recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS I | Enroute Transcarotid Neuroprotection System Plus recalled | Boston Scientific | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |