Recall archive / FDA device enforcement

CX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404430 (12CM PS IZ), (2) 72404431 (15CM PS IZ), (3)... — FDA record Z-0142-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 11, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: 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);
Reason: The potential for devices to experience inflation and/or deflation performance issues or difficulties.
Classification: Class II
Recalling firm: Boston Scientific Corporation
Quantity: 2288 units
Agency-reported status: Ongoing
Source record identifier: Z-0142-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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, 1...

Label field

Details supplied by the agency

Lot, code or applicability

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, 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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, 1...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Oct 22, 2025
Recall initiation date: Sep 11, 2025
Center classification date: Oct 10, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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Lot and product identifiers

Distribution

Dates in the source

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