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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 97603

7 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 11, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Boston Scientific Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

7 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 7

TENACIO Pump with InhibiZone; UPN: 72404429;

Z-0138-2026
Recall number
Z-0138-2026
Initiated
September 11, 2025
Classification
Class II
Status
Ongoing
Quantity
59 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for devices to experience inflation and/or deflation performance issues or difficulties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Code information

UPN: 72404429; UDI-DI: Lot numbers: 1100551131, 1100551132, 1100551134, 1100551135, 1100551136, 1100551137, 1100551139, 1100551145, 1100551149, 1100553579, 1100553580, 1100553582, 1100553583, 1100553584, 1100553585, 1100553586, 1100553588, 1100553589, 1100553590, 1100553591, 1100553594, 1100553595, 1100553596, 1100579593, 1100579596, 1100579598, 1100579599, 1100579600, 1100579639, 1100579640, 1100579642, 1100579643, 1100579646, 1100580141, 1100580143, 1100580144, 1100580145, 1100580146, 1100580149, 1100580598, 1100580599, 1100580600, 1100580601, 1100580605, 1100580608, 1100580609, 1100580610, 1100580612, 1100678770, 1100678774, 1100678775, 1100678776, 1100679129, 1100687128, 1100687130, 1100687133, 1100687134, 1100687135, 1100687140, 1100687142, 1100717769, 1100717773, 1100717774, 1100717775, 1100717776, 1100553592, 1100551147, 1100551138, 1100553597, 1100551146, 1100551142, 1100551148, 1100551141, 1100579595, 1100580147, 1100580606, 1100579641, 1100580607, 1100580595, 1100580603, 1100579601, 1100580148, 1100580597, 1100580596, 1100580613, 1100580611, 1100678777, 1100687129, 1100679130, 1100678773, 1100721233, 1100721238;

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 2 of 7

TENACIO Pump without InhibiZone; UPN: 72404420;

Z-0139-2026
Recall number
Z-0139-2026
Initiated
September 11, 2025
Classification
Class II
Status
Ongoing
Quantity
0 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for devices to experience inflation and/or deflation performance issues or difficulties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Code information

UPN: 72404420; UDI-DI: Lot numbers: 1100720566, 1100720567, 1100720568;

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 3 of 7

CX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404486 (15CM IP), (2) 72404488 (21CM IP);

Z-0140-2026
Recall number
Z-0140-2026
Initiated
September 11, 2025
Classification
Class II
Status
Ongoing
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for devices to experience inflation and/or deflation performance issues or difficulties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Code information

1. UPN: 72404486 (15CM IP); UDI-DI: 00191506021658; Lot numbers: 1100676851, 1100676852; 2. UPN: 72404488 (21CM IP); UDI-DI: 00191506021672; Lot numbers: 1100717673;

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 4 of 7

LGX Preconnect with TENACIO Pump without InhibiZone; UPNs: (1) 72404405 (12CM IP), (2) 72404407 (18CM IP);

Z-0141-2026
Recall number
Z-0141-2026
Initiated
September 11, 2025
Classification
Class II
Status
Ongoing
Quantity
0 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for devices to experience inflation and/or deflation performance issues or difficulties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Code information

1. UPN: 72404405 (12CM IP); UDI-DI: 00191506021252; Lot numbers: 1100687060, 1100687061; 2. UPN: 72404407 (18CM IP); UDI-DI: 00191506021276; Lot numbers: 1100676894, 1100676895;

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 5 of 7

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);

Z-0142-2026
Recall number
Z-0142-2026
Initiated
September 11, 2025
Classification
Class II
Status
Ongoing
Quantity
2288 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for devices to experience inflation and/or deflation performance issues or difficulties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Code information

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;

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 6 of 7

CXR Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404461 (12CM PS IZ), (2) 72404462 (14CM PS IZ), (3) 72404463 (16CM PS IZ), (4) 72404464 (18CM PS IZ), (5) 72404465 (10CM IP IZ), (6) 72404466 (12CM IP IZ), (7) 72404467 (14CM IP IZ), (8) 72404468 (16CM IP IZ), (9) 72404469 (18CM IP IZ);

Z-0143-2026
Recall number
Z-0143-2026
Initiated
September 11, 2025
Classification
Class II
Status
Ongoing
Quantity
172 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for devices to experience inflation and/or deflation performance issues or difficulties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Code information

1. UPN: 72404461 (12CM PS IZ); UDI-DI: 00191506021504; Lot numbers: 1100398868, 1100398869, 1100398870, 1100398871, 1100398872, 1100398873, 1100398874, 1100398875, 1100398876, 1100398877, 1100522368, 1100543829, 1100574579, 1100590200, 1100590204, 1100590209, 1100599084, 1100599107, 1100599108, 1100599109, 1100610211, 1100610217, 1100569383, 1100522373, 1100543834, 1100543827, 1100522371, 1100522370, 1100522369, 1100522365, 1100574581, 1100543831, 1100574584, 1100522367, 1100569385, 1100522374, 1100574582, 1100578423, 1100543828, 1100574580, 1100578426, 1100578429, 1100522372, 1100568487, 1100604371, 1100590208, 1100604359, 1100599081, 1100610213, 1100604362, 2. UPN: 72404462 (14CM PS IZ); UDI-DI: 00191506021511; Lot numbers: 1100489498, 1100489542, 1100489543, 1100489544, 1100489547, 1100489549, 1100543855, 1100543857, 1100599134, 1100599138, 1100599195, 1100599201, 1100599204, 1100602511, 1100602512, 1100602514, 1100602561, 1100602563, 1100602566, 1100605702, 1100605706, 1100605714, 1100605715, 1100609592, 1100613514, 1100621453, 1100621454, 1100625387, 1100625388, 1100625391, 1100522433, 1100489493, 1100489492, 1100489495, 1100543858, 1100489546, 1100489494, 1100489496, 1100543859, 1100543864, 1100489497, 1100625392, 1100625394, 1100613511, 1100605718, 1100625393, 1100602694, 1100599203, 1100609585, 1100602695, 1100605709, 1100605710, 1100602564, 1100599196, 1100677511, 1100677506, 1100677507, 1100677509, 1100715069, 3. UPN: 72404463 (16CM PS IZ); UDI-DI: 00191506021528; Lot numbers: 1100480549, 1100480555, 1100480559, 1100480561, 1100480562, 1100480567, 1100492188, 1100511647, 1100511648, 1100511652, 1100511653, 1100511654, 1100511655, 1100511705, 1100511711, 1100546879, 1100546880, 1100546881, 1100551274, 1100551275, 1100551276, 1100551280, 1100560945, 1100560950, 1100565155, 1100565156, 1100565163, 1100565574, 1100565578, 1100565579, 1100565580, 1100565629, 1100565632, 1100565634, 1100565635, 1100602136, 1100602140, 1100602194, 1100602195, 1100602197, 1100602227, 1100602228, 1100602229, 1100605207, 1100605211, 1100605214, 1100614920, 1100615585, 1100615587, 1100619169, 1100619173, 1100619174, 1100657322, 1100657324, 1100657325, 1100511649, 1100565159, 1100511709, 1100560952, 1100480550, 1100480568, 1100565581, 1100492184, 1100546878, 1100546876, 1100546877, 1100546875, 1100480557, 1100511650, 1100511704, 1100480553, 1100480552, 1100480558, 1100480551, 1100511702, 1100511651, 1100511703, 1100480556, 1100565631, 1100560953, 1100605206, 1100602225, 1100602196, 1100614923, 1100602192, 1100602223, 1100606735, 1100615594, 1100615588, 1100614926, 1100619170, 1100615590, 1100615589, 1100602193, 1100602199, 1100602201, 1100605210, 1100690401, 1100657331, 1100657330, 1100663408, 1100663399, 1100657326, 4. UPN: 72404464 (18CM PS IZ); UDI-DI: 00191506021535; Lot numbers: 1100591058, 1100591064, 1100591059, 5. UPN: 72404465 (10CM IP IZ); UDI-DI: 00191506021542; Lot numbers: 1100590252, 1100557278, 6. UPN: 72404466 (12CM IP IZ); UDI-DI: 00191506021559; Lot numbers: 1100398535, 1100398536, 1100398537, 1100398538, 1100398539, 1100398540, 1100398541, 1100398542, 1100556794, 1100491464, 1100491466, 1100573736, 1100491465, 1100573773, 1100491472, 1100565103, 1100573739, 1100512182, 1100554190, 1100512180, 1100491470, 1100491471, 1100491467, 1100512183, 1100554188, 1100556786, 1100573737, 1100573738, 1100491463, 1100573774, 1100512181, 1100573732, 1100491469, 1100573730, 1100491468, 1100554187, 1100627360, 1100627357, 1100627355, 1100668336, 1100668329, 1100668337, 7. UPN: 72404467 (14CM IP IZ); UDI-DI: 00191506021566; Lot numbers: 1100492102, 1100554145, 1100569162, 1100569187, 1100574563, 1100585072, 1100626261, 1100512197, 1100554148, 1100492110, 1100512198, 1100569181, 1100572069, 1100569180, 1100556843, 1100554150, 1100569165, 1100556842, 1100492104, 1100574559, 1100569179, 1100569161, 1100554146, 1100492103, 1100512202, 1100512196, 1100574566, 1100572068, 1100569159, 1100556839, 1100512201, 1100569184, 1100626262, 1100585076, 1100626260, 8. UPN: 72404468 (16CM IP IZ); UDI-DI: 00191506021573; Lot numbers: 1100524763, 1100524766, 1100554179, 1100554180, 1100560191, 1100560905, 1100560907, 1100569608, 1100569612, 1100569649, 1100569656, 1100573275, 1100574054, 1100574055, 1100574058, 1100574059, 1100574062, 1100624980, 1100624983, 1100624987, 1100624988, 1100626293, 1100626296, 1100554173, 1100560903, 1100524760, 1100573278, 1100569609, 1100490867, 1100569610, 1100524761, 1100560908, 1100554175, 1100560197, 1100574056, 1100569605, 1100554177, 1100574057, 1100574060, 1100490863, 1100560900, 1100569648, 1100573273, 1100573269, 1100569604, 1100560906, 1100569657, 1100524758, 1100626288, 1100626295, 1100626292, 9. UPN: 72404469 (18CM IP IZ); UDI-DI: 00191506021580; Lot numbers: 1100624977, 1100624974, 1100624975, 1100624978, 1100624969, 1100624976, 1100624970, 1100624973,

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.

device · product 7 of 7

LGX Preconnect with TENACIO Pump with InhibiZone; UPNs: (1) UPN: 72404450 (12CM PS IZ), (2) 72404451 (15CM PS IZ), (3) 72404452 (18CM PS IZ), (4) 72404453 (21CM PS IZ), (5) 72404455 (12CM IP IZ), (6) 72404456 (15CM IP IZ), (7) 72404457 (18CM IP IZ), (8) 72404458 (21CM IP IZ);

Z-0144-2026
Recall number
Z-0144-2026
Initiated
September 11, 2025
Classification
Class II
Status
Ongoing
Quantity
490 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The potential for devices to experience inflation and/or deflation performance issues or difficulties.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The potential for devices to experience inflation and/or deflation performance issues or difficulties.

Code information

1. UPN: 72404450 (12CM PS IZ); UDI-DI: 00191506021412; Lot numbers: 1100404813, 1100404817, 1100404818, 1100404819, 1100404820, 1100404821, 1100558512, 1100565086, 1100568924, 1100585061, 1100596471, 1100596473, 1100617027, 1100404816, 1100404814, 1100404815, 1100558509, 1100512315, 1100565093, 1100512387, 1100565088, 1100558508, 1100512313, 1100512388, 1100565084, 1100568927, 1100568926, 1100611812, 1100585059, 1100596478, 1100598982, 1100611809, 1100596324, 1100596477, 1100596472, 1100579740, 1100585066, 1100585064, 1100579739, 1100619111, 1100626304, 1100611810, 2. UPN: 72404451 (15CM PS IZ); UDI-DI: 00191506021429; Lot numbers: 1100480113, 1100480114, 1100480115, 1100480117, 1100480622, 1100480623, 1100480624, 1100480625, 1100480626, 1100480627, 1100480628, 1100511666, 1100511668, 1100511669, 1100511671, 1100511673, 1100558263, 1100558264, 1100558265, 1100563672, 1100563673, 1100563674, 1100563676, 1100563679, 1100563680, 1100584476, 1100584477, 1100584479, 1100584481, 1100584482, 1100584483, 1100592722, 1100592723, 1100592724, 1100592725, 1100592726, 1100592728, 1100595757, 1100595758, 1100595762, 1100595763, 1100595764, 1100595785, 1100595786, 1100595787, 1100595788, 1100609511, 1100609512, 1100609514, 1100613865, 1100613869, 1100613870, 1100613871, 1100613872, 1100613873, 1100614058, 1100614059, 1100614061, 1100614062, 1100614063, 1100614064, 1100614065, 1100615565, 1100615568, 1100615571, 1100615572, 1100615573, 1100636975, 1100636981, 1100636982, 1100636983, 1100656099, 1100656107, 1100666343, 1100666344, 1100666347, 1100666352, 1100670774, 1100670779, 1100683615, 1100683617, 1100683618, 1100683621, 1100685703, 1100685751, 1100685752, 1100686397, 1100686399, 1100686405, 1100687070, 1100687079, 1100692405, 1100692409, 1100695717, 1100695719, 1100695720, 1100695723, 1100723763, 1100723774, 1100563677, 1100558258, 1100592721, 1100609517, 1100592727, 1100595761, 1100609513, 1100636980, 1100614060, 1100614066, 1100636978, 1100592729, 1100584478, 1100584475, 1100595760, 1100595789, 1100615566, 1100695718, 1100666350, 1100656100, 1100685758, 1100656103, 1100685705, 1100685756, 1100666346, 1100692404, 1100685708, 1100695722, 1100692403, 1100685702, 1100656104, 1100685701, 1100656102, 1100685755, 1100692401, 1100656105, 1100686403, 1100723777, 3. UPN: 72404452 (18CM PS IZ); UDI-DI: 00191506021436; Lot numbers: 1100480677, 1100480678, 1100480679, 1100480680, 1100480681, 1100480683, 1100480684, 1100480685, 1100481060, 1100481061, 1100481062, 1100481063, 1100481064, 1100481065, 1100481066, 1100481067, 1100481068, 1100481069, 1100489331, 1100489333, 1100489334, 1100489335, 1100489336, 1100489337, 1100489338, 1100489339, 1100489340, 1100489401, 1100489402, 1100489403, 1100489404, 1100489405, 1100489406, 1100489407, 1100489408, 1100509667, 1100509668, 1100509669, 1100509670, 1100509671, 1100509672, 1100509673, 1100509674, 1100509675, 1100509676, 1100526020, 1100526022, 1100526023, 1100526024, 1100526025, 1100526026, 1100526027, 1100527427, 1100527428, 1100527430, 1100527431, 1100527432, 1100527433, 1100527434, 1100534298, 1100534299, 1100534300, 1100534301, 1100534302, 1100534303, 1100534304, 1100534305, 1100534306, 1100534307, 1100563839, 1100563840, 1100563841, 1100563842, 1100563843, 1100563844, 1100563845, 1100563847, 1100573665, 1100573666, 1100573668, 1100573669, 1100573670, 1100573671, 1100573672, 1100573673, 1100578326, 1100578327, 1100578328, 1100578329, 1100578330, 1100578332, 1100578333, 1100578334, 1100578335, 1100582002, 1100582004, 1100582005, 1100582006, 1100582008, 1100582009, 1100582011, 1100582030, 1100582031, 1100582033, 1100582034, 1100591038, 1100591039, 1100591040, 1100591041, 1100591043, 1100591044, 1100591045, 1100591046, 1100591047, 1100614940, 1100614941, 1100614942, 1100614944, 1100614946, 1100614947, 1100614948, 1100614949, 1100614970, 1100614972, 1100614973, 1100614974, 1100614975, 1100614976, 1100614977, 1100614978, 1100614979, 1100615058, 1100615059, 1100615060, 1100615061, 1100615062, 1100615063, 1100615064, 1100620589, 1100620590, 1100620591, 1100620595, 1100620596, 1100620597, 1100622718, 1100622721, 1100622722, 1100622724, 1100622726, 1100625061, 1100625062, 1100625063, 1100625064, 1100625065, 1100625067, 1100625068, 1100654712, 1100654714, 1100654718, 1100654719, 1100654720, 1100657159, 1100657160, 1100657161, 1100657162, 1100660268, 1100660270, 1100660271, 1100660272, 1100660274, 1100665201, 1100665202, 1100665207, 1100665208, 1100665209, 1100665211, 1100665216, 1100665218, 1100665219, 1100665220, 1100666171, 1100666173, 1100666174, 1100666175, 1100666176, 1100666177, 1100666178, 1100666179, 1100666180, 1100666182, 1100666183, 1100666184, 1100666185, 1100669329, 1100669332, 1100669333, 1100669335, 1100669337, 1100669338, 1100670829, 1100670830, 1100670831, 1100670832, 1100670833, 1100683504, 1100683506, 1100683507, 1100683509, 1100683510, 1100683511, 1100683909, 1100683910, 1100683912, 1100683913, 1100683915, 1100683916, 1100683917, 1100683918, 1100687319, 1100687322, 1100687324, 1100687325, 1100687929, 1100687930, 1100687932, 1100687933, 1100687934, 1100687936, 1100687937, 1100687938, 1100690681, 1100690682, 1100690684, 1100690686, 1100690688, 1100691647, 1100691648, 1100691649, 1100691652, 1100697431, 1100697432, 1100697433, 1100697434, 1100710464, 1100710471, 1100710472, 1100710473, 1100489332, 1100527429, 1100573674, 1100480676, 1100591042, 1100582032, 1100654717, 1100654715, 1100654716, 1100614943, 1100582007, 1100620594, 1100665203, 1100666169, 1100665212, 1100690683, 1100657158, 1100666170, 1100683914, 1100687318, 1100687931, 1100660269, 1100683505, 1100665206, 1100660275, 1100690685, 1100697436, 1100666172, 1100691656, 1100660273, 1100683512, 1100657163, 1100710468, 4. UPN: 72404453 (21CM PS IZ); UDI-DI: 00191506021443; Lot numbers: 1100527254, 1100527256, 1100547607, 1100547610, 1100547613, 1100547615, 1100553676, 1100553680, 1100615799, 1100615802, 1100615806, 1100615807, 1100615808, 1100627337, 1100627340, 1100628656, 1100628657, 1100628658, 1100628659, 1100632123, 1100632124, 1100636857, 1100678269, 1100687081, 1100687084, 1100713232, 1100547611, 1100527260, 1100527263, 1100542413, 1100553678, 1100542412, 1100628651, 1100615800, 1100615805, 1100636859, 1100636860, 1100615801, 1100628655, 1100636864, 1100628650, 1100627339, 1100636865, 1100636862, 1100678264, 1100678267, 1100692151, 1100687083, 1100692146, 5. UPN: 72404455 (12CM IP IZ); UDI-DI: 00191506021450; Lot numbers: 1100491487, 1100573783, 1100581262, 1100581263, 1100581266, 1100581297, 1100573778, 1100573776, 1100573782, 1100491491, 1100569277, 1100573781, 1100491492, 1100570202, 1100491486, 1100596863, 1100581305, 1100596861, 1100581304, 1100596862, 1100581306, 1100581300, 1100584903, 1100596864, 1100581271, 1100596858, 1100581302, 1100581269, 1100584900, 1100581301, 1100584899, 1100581267, 1100584897, 1100679354, 1100679350, 6. UPN: 72404456 (15CM IP IZ); UDI-DI: 00191506021467; Lot numbers: 1100481228, 1100481229, 1100481230, 1100481231, 1100481233, 1100481234, 1100481235, 1100481237, 1100629264, 1100629272, 1100629273, 1100651201, 1100651205, 1100651210, 1100651212, 1100651213, 1100651214, 1100651215, 1100655196, 1100668323, 1100668324, 1100670786, 1100670790, 1100673337, 1100673338, 1100673343, 1100673344, 1100676819, 1100690779, 1100690780, 1100690787, 1100690790, 1100716504, 1100716521, 1100481236, 1100481232, 1100629266, 1100651211, 1100651209, 1100655194, 1100655202, 1100651204, 1100655197, 1100655193, 1100651203, 1100651217, 1100676816, 1100690792, 1100668322, 1100690783, 1100690794, 1100676817, 1100670788, 1100670785, 1100716522, 1100716514, 1100716509, 1100716512, 7. UPN: 72404457 (18CM IP IZ); UDI-DI: 00191506021474; Lot numbers: 1100398489, 1100398490, 1100398491, 1100398492, 1100398493, 1100398494, 1100398495, 1100398496, 1100481311, 1100481312, 1100481314, 1100481316, 1100481317, 1100481318, 1100481319, 1100481320, 1100535385, 1100535386, 1100535387, 1100535388, 1100535389, 1100535390, 1100535391, 1100535392, 1100613884, 1100613885, 1100613886, 1100613887, 1100613888, 1100613889, 1100613890, 1100613891, 1100613892, 1100629807, 1100629809, 1100629810, 1100629811, 1100629812, 1100629813, 1100629814, 1100651802, 1100651803, 1100651804, 1100651808, 1100651837, 1100651838, 1100651839, 1100651840, 1100651845, 1100655625, 1100655626, 1100655627, 1100655628, 1100655629, 1100655631, 1100655632, 1100655633, 1100655634, 1100655710, 1100655711, 1100655712, 1100655713, 1100655716, 1100655717, 1100655718, 1100657357, 1100657358, 1100657359, 1100657361, 1100657364, 1100667614, 1100667615, 1100667616, 1100667617, 1100667618, 1100667619, 1100667620, 1100667623, 1100667624, 1100667626, 1100667627, 1100667628, 1100667631, 1100668311, 1100668313, 1100668315, 1100668316, 1100668317, 1100695663, 1100695665, 1100712622, 1100712630, 1100714749, 1100726414, 1100726417, 1100726418, 1100726419, 1100481315, 1100481313, 1100651807, 1100655714, 1100655709, 1100667613, 1100695659, 1100667630, 1100657360, 1100668312, 1100695666, 1100668318, 1100714743, 1100714751, 1100714748, 1100726416, 1100712631, 8. UPN: 72404458 (21CM IP IZ); UDI-DI: 00191506021481; Lot numbers: 1100401206, 1100401207, 1100401208, 1100401209, 1100401210, 1100401211, 1100401212, 1100401213, 1100401214, 1100527092, 1100527095, 1100527100, 1100538045, 1100545960, 1100545961, 1100545968, 1100556132, 1100556135, 1100556136, 1100579477, 1100579479, 1100579480, 1100579482, 1100579483, 1100579488, 1100579494, 1100603659, 1100603662, 1100620429, 1100620431, 1100621446, 1100621448, 1100621450, 1100658988, 1100658995, 1100658996, 1100688010, 1100688011, 1100688012, 1100579484, 1100579493, 1100556134, 1100579478, 1100579487, 1100579491, 1100556137, 1100579476, 1100527096, 1100579489, 1100527097, 1100556138, 1100603665, 1100603658, 1100603661, 1100621451, 1100621443, 1100621449, 1100621445, 1100636814, 1100603660, 1100658991, 1100688007, 1100658989, 1100658997, 1100688008, 1100688005;

Distribution pattern

Worldwide distribution - US Nationwide and the country of Canada.