Drug & Device Safety Atlas
Class II FDA device recall · Z-0706-2024

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

XScribe Cardiac Stress Testing System, version 6, with below product names and codes: a) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-BXXXX; b) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-DXXXX; c) XS6/RS6 REVIEW WKSTN KIT, XR-6AC-XXXXX; d) XS6 WAM TTL KIT IEC XML BRAZIL, XSCRIBE-5AX-XXBRZ; e) XS6 WAM TTL SYS Z200 AHA XML, XSCRIBE-6AA-AAAAA; f) XS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-ADBXX; g) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAAA; h) XS6 WAM TTL SYS Z200 PCRT AHA SVR, XSCRIBE-6AA-AFAAC; i) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-AFAXA; j) XS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-AFAXB; k) XS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AA-BCAAB; l) XS6 WAM TTL SYS AHA XML, XSCRIBE-6AA-BXAAA; m) XS6 WAM TTL SYS AHA DICOM, XSCRIBE-6AA-BXAAB; n) XS6 WAM TTL SYS AHA, XSCRIBE-6AA-BXAXX; o) XS6 WAM TTL SYS Z200 BCRT IEC XML, XSCRIBE-6AA-CDBAA; p) XS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-CDBAB; q) XS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AA-CDBAC; r) XS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AA-CDBAX; s) XS6 WAM TTL SYS BCRT AHA DICOM, XSCRIBE-6AA-CEAAB; t) XS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AA-CEBAB; u) XS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AA-DDBAB; v) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-DGAAA; w) XS6 WAM TTL SYS Z200 PCRT IEC DICOM, XSCRIBE-6AA-DGBAB; x) XS6 WAM TTL SYS Z200 PCRT IEC, XSCRIBE-6AA-DGBAX; y) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAAA; z) XS6 WAM TTL SYS Z200 PCRT AHA DICOM, XSCRIBE-6AA-XFAAB; aa) XS6 WAM TTL SYS Z200 PCRT AHA XML, XSCRIBE-6AA-XFAXA; bb) XS6 WAM TTL SYS Z200 PCRT IEC XML, XSCRIBE-6AA-XFBXA; cc) XS6 WAM TTL SYS BCRT AHA, XSCRIBE-6AB-BEAXX; dd) XS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-BXAXA; ee) XS6 WAM TTL SYS Z200 BCRT AHA XML, XSCRIBE-6AB-CDAAA; ff) XS6 WAM TTL SYS Z200 BCRT AHA DICOM, XSCRIBE-6AB-CDAAB; gg) XS6 WAM TTLSYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAA; hh) XS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-CDBAB; ii) XS6 WAM TTL SYS Z200 BCRT IEC SVR, XSCRIBE-6AB-CDBAC; jj) XS6 WAM TTL SYS BCRT AHA XML, XSCRIBE-6AB-CEAAA; kk) XS6 WAM TTL SYS BCRT IEC, XSCRIBE-6AB-CEBAX; ll) XS6 WAM TTL SYS Z200 BCRT IEC DICOM, XSCRIBE-6AB-DDBAB; mm) XS6 WAM TTL SYS Z200 BCRT IEC, XSCRIBE-6AB-DDBAX; nn) XS6 WAM TTL SYS BCRT IEC XML, XSCRIBE-6AB-DEBAA; oo) XS6 WAM TTL SYS BCRT IEC DICOM, XSCRIBE-6AB-DEBAB; pp) XS6 WAM TTL SYS BCRT IEC SVR, XSCRIBE-6AB-DEBAC; qq) XS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAAA; rr) XS6 WAM TTL SYS AHA XML, XSCRIBE-6AB-DXAXA; ss) XS6 WAM TTLSYS Z200 BCRT AHA XML, XSCRIBE-6AB-XCAAA; tt) XS6 WAM TTLKIT Z200 AHA DICOM, XSCRIBE-6AC-AAAAB; uu) XS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAAX; vv) XS6 WAM TTL KIT Z200 AHA, XSCRIBE-6AC-AAAXX; ww) XS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAAX; xx) XS6 WAM TTL KIT Z200 BCRT AHA, XSCRIBE-6AC-ACAXX; yy) XS6 WAM TTL KIT BCRT AHA XML, XSCRIBE-6AC-AEAAA; zz) XS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-AEAXX; aaa) XS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAAA; bbb) XS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-AXAXA; ccc) XS6 WAM TTL KIT AHA, XSCRIBE-6AC-AXAXX; ddd) XS6 WAM TTL KIT Z200 BCRT AHA DICOM, XSCRIBE-6AC-BDAAB; eee) XS6 WAM TTL KIT BCRT AHA SVR, XSCRIBE-6AC-BEAAC; fff) XS6 WAM TTL KIT BCRT AHA, XSCRIBE-6AC-BEAXX; ggg) XS6 WAM TTL KIT AHA XML, XSCRIBE-6AC-BXAXA; hhh) XS6 WAM TTL KIT AHA, XSCRIBE-6AC-BXAXX; iii) XS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-CDBAA; jjj) XS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-CDBAB; kkk) XS6 WAM TTL KIT BCRT IEC, XSCRIBE-6AC-CEBAX; lll) XS6 WAM TTL KIT IEC XML, XSCRIBE-6AC-CXBAA; mmm) XS6 WAM TTL KIT IEC DICOM, XSCRIBE-6AC-CXBAB; nnn) XS6 WAM TTL KIT Z200 IEC XML, XSCRIBE-6AC-DBBXA; ooo) XS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DCBXA; ppp) XS6 WAM TTL KIT Z200 BCRT IEC XML, XSCRIBE-6AC-DDBAA; qqq) XS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBAB; rrr) XS6 WAM TTL KIT Z200 BCRT IEC DICOM, XSCRIBE-6AC-DDBXB; sss) XS6 WAM TTL KIT BCRT IEC XML, XSCRIBE-6AC-DEBAA; ttt) XS6 WAM TTL KIT BCRT IEC

Why it was recalled

Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information 
Product Code, UDI/DI Number, Serial Numbers  a) 41000-030-50, UDI/DI None, Serial Numbers:  110120039437, 110120039438, 110120039439, 110190044556, 110190044557, 110190044558, 110190044559, 110190044560, 110190044561, 110190044562, 110190044563, 110190044564, 110190044565, 110190044566, 110190044567, 110200045831, 110200045832, 110200045833, 110200045834, 110200045835, 110260052818, 110260052819, 110260052820, 110260052821, 110260052822, 110260052823, 110420061166, 110420061167, 110420061168, 110420061169, 110460064753, 110460064754, 110460064755, 110460064697, 110460064698, 110460064699, 110460064700, 110460064702, 110460064703, 110460064704, 110460064705, 110460064706, 111150077803, 111150077804, 111150077805, 111150077806, 111150077807, 111150077808, 111150077809, 111200081334, 111200081335, 111200081336, 111200081337, 111200081338, 111200081339, 111200081340, 111200081341, 111300088621, 111300088622, 111300088623, 111300088624, 111300088625, 111300088626, 111300088627, 111340091242, 111340091243, 111360092140, 111360092141, 111360092142, 111360092143, 111360092144, 111340091246, 111340091247, 111340091248, 111340091249, 111340091250, 111420097839, 111420097840, 111420097841, 111420097842, 111420097843, 111500103083, 111500103084, 111500103085, 111500103086, 111530104948, 111530104949, 111530104950, 111530104951, 112020106363, 112020106364, 112020106365, 112020106366, 112020106367, 112020106368, 112020106369, 112020106370, 112180115629, 112180115630, 112180115631, 112180115632, 112180115633, 112180115634, 112180115635, 112200117094, 112200117095, 112200117096, 112200117097, 112200117098, 112200117099, 112200117100, 112200117101, 112200117102, 112200117103, 112320128027, 112320128028, 112320128029, 112320128030, 112320128031, 112350130930, 112350130931, 112350130932, 112350130933, 112350130934, 112350130935, 112350130936, 112350130937, 112440138921, 112440138922, 112440138923, 112440138924, 112440138925, 112440138926, 112440138927, 112440138928, 112440138929, 112440138930, 112440138931, 112440138932, 113010147090, 113010147091, 113010147092, 113010147093, 113070153116, 113070153117, 113070153118, 113070153119, 113070153120, 113070153121, 113070153122, 113070153123, 113070153124, 113070153125, 113070153126, 113070153127, 113070153128, 113070153129, 113270168996, 113270168997, 113270168998, 113270168999, 113270169000, 113310172113, 113310172114, 113310172115, 113310172116, 113350174038, 113350174039, 113350174040, 113350174041, 113350174046, 113350174047, 113350174042, 113350174043, 113350174044, 113350174045, 113410177775, 113410177776, 113410177777, 113410177778, 113410177779, 113410177780, 113410177781, 113440180951, 113440180952, 113440180953, 113470184299, 113470184300, 113470184301, 113530189429, 113530189430, 113530189431, 113530189432, 113530189433, 113530189434, 114050192901, 114050192902, 114050192903, 114090196065, 114090196066, 114090196067, 113460182788, 113460182789, 113460182790, 113460182791, 113460182792, 113460182793, 114420232656, 114420232657, 114420232658, 114420232659, 114420232660, 114420232661, 114480237409, 114480237410, 114420232662, 114420232663, 114420232664, 114420232665, 114520240984, 114520240985, 114520240986, 114520240987, 114520240988, 114520240989, 115050243901, 115050243902, 115050243903, 114470236646, 114470236647, 114470236648, 115230258572, 115230258573, 115230258574, 115230258575, 115230258576, 115230258424, 115230258425, 115230258426, 115280263454, 115280263455, 115280263456, 115280263457, 115280263458, 115280263459, 115280264206, 115280264207, 115280264208, 115280264209, 115280264210, 115280264211, 115330268899, 115330268900, 115330268901, 115330268902, 115330268903, 115330268904, 115400275479, 115400275480, 115400275481, 115400275482, 115400275483, 115400275484, 115400275485, 115400275486, 115400275487, 115400275488, 116020287198, 116020287199, 116020287200, 116100335156, 116100335157, 116100335158, 116130382423, 116130382424, 116130382425, 116130382426, 116130382427, 116180422043, 116180422044, 116180422045, 116180422046, 116180422047, 116240477718, 116240477719, 116240477720, 116240477721, 116270497993, 116270497994, 116270497995, 116270497996, 116380527123, 116380527124, 116380527125, 116380527126, 116380527127, 116380527128, 116380527129, 116380527130;  b) 41000-030-51, UDI/DI None, Serial Numbers:  110120039425, 110120039426, 110120039427, 110190044568, 110190044569, 110190044570, 110200045836, 110200045837, 110200045838, 110330056675, 110330056676, 110370059009, 110370059010, 110370059011, 110390059824, 110420060941, 110420060942, 110500066898, 110500066899, 110500066900, 111060071714, 111060071715, 111060071716, 111150077462, 111150077463, 111200081342, 111200081343, 111270086404, 111270086405, 111270086406, 111270086407, 111380093553, 111380093554, 111380093555, 111380093556, 111380093557, 111470101214, 111470101215, 111500103087, 111500103088, 111500103089, 112030106627, 112030106628, 112050108028, 112050108029, 112100110764, 112100110765, 112050108026, 112050108027, 112220118711, 112220118712, 112220118713, 112270124286, 112270124287, 112270124288, 112320128032, 112320128033, 112320128034, 112410137135, 112410137136, 112410137137, 112440139667, 112440139668, 112440138933, 112440138934, 112440138935, 112440138936, 112440138937, 112440138938, 113020147730, 113020147731, 113020147732, 113020147733, 113020147734, 113020147735, 113020147736, 113020147737, 113130159216, 113130159217, 113130159218, 113130159219, 113130159220, 113130159221, 113130159222, 113130159223, 113130159224, 113130159225, 113130159226, 113130159227, 113130159228, 113130159229, 113130159230, 113450181907, 113450181908, 113480185307, 113480185308, 113450181644, 113450181645, 113450181646, 113450181647, 113450181648, 113450181649, 113450181650, 113450181651, 113450181652, 113450181653, 114380229638, 114380229639, 114440234317, 114440234325, 114470236649, 114470236650, 114480237351, 114480237352, 114480237353, 114480237354, 114480237349, 114480237350, 115060244042, 115060244043, 115100247551, 115100247552, 115100247553, 115140251901, 115140251902, 115140251903, 115140251904, 115140251905, 115140251906, 115140251907, 115140251908, 115200256104, 115200256105, 115230258565, 115230258566, 115230258567, 115230258568, 115240258971, 115240258972, 115240258973, 115240258974, 115200256100, 115200256101, 115200256102, 115200256103, 116020287201, 116020287202, 116050291262, 116050291263, 116100335159, 116100335160, 116140387942, 116140387943, 116140387944, 116180423551, 116180423552;  c) 41000-030-52, UDI/DI None, Serial Numbers:  110120039363, 110120039364, 110230049218, 110230049219, 110230049220, 110230049221, 110280053721, 110280053722, 110280053723, 110280053724, 110280053725, 110330056793, 110330056794, 110370059012, 110370059013, 110370059014, 110410060508, 110410060509, 110410060510, 110410060511, 110440063042, 110440063043, 110440063044, 110440063045, 110460064750, 110460064751, 110460064752, 110460064707, 110460064708, 110460064709, 110460064710, 110460064711, 110460064712, 110460064713, 110460064714, 111060071710, 111060071711, 111060071712, 111060071713, 111200081535, 111200081536, 111200081537, 111230083963, 111230083964, 111230083965, 111330090559, 111330090560, 111330090561, 111330090562, 111330090563, 111330090564, 111330090565, 111450099468, 111450099469, 111450099470, 111450099471, 111450099472, 111450099473, 111450099474, 111450099475, 111460100779, 111460100780, 111460100781, 111490102399, 111490102400, 111490102401, 111460100426, 111460100427, 111460100428, 112020105816, 112020105817, 112020105818, 112020105819, 112020105820, 112020105821, 112130112152, 112130112153, 112130112154, 112130112155, 112130112156, 112130112157, 112280125032, 112280125033, 112280125034, 112280125035, 112280125036, 112280125037, 112250123314, 112250123315, 112250123316, 112250123317, 113100155571, 113100155572, 113130159201, 113130159202, 113130159203, 113130159204, 113130159205, 113130159206, 113130159207, 113130159208, 113130159209, 113130159210, 113130159211, 113130159212, 113130159213, 113130159214, 113130159215, 114020190211, 114020190212, 114020190213, 114020190214, 114020190215, 114020190216, 114020190217, 114180209245, 114180209246, 114020190218, 114020190219, 114180209247, 114180209248, 114180209249, 114180209250, 114180209251, 114180209252, 114250218419, 114460236532, 114460236533, 114460236534, 114460236529, 114460236530, 114460236531, 114460236526, 114460236527, 114460236528, 115260260562, 115260260563, 115260260564, 115360271118, 115360271119, 115360271120, 115440278666, 115440278667, 115440278668, 115500283264, 115500283265, 115500283266, 116050290129, 116050290130, 116050290131, 116050290132, 116110349285, 116110349286, 116110349287, 116110349288, 116110349289, 116200433074, 116200433075, 116230452680, 116230452681, 116230452682, 116280504772, 116280504773, 116280504774;  d) 41000-030-53, UDI/DI None, Serial Numbers:  110120039428, 110120039429, 110120039430, 110120039431, 110120039432, 110120039433, 110120039434, 110120039435, 110120039436;  e) 41000-030-60, UDI/DI 00817655020051, Serial Numbers:  118060611436, 118060611438, 118060611439, 118080615013, 118080615022, 118180634934, 118080615011, 118180634932, 118180634933, 118180634936, 118060611447, 118080615017, 118080615018, 118080615021, 118080615019, 118080615020, 118180634938, 118180634939, 118180634940, 118160628568, 118160628569, 118160628570, 118180634931, 118180634935, 118160628577, 118160628578, 118160628579, 118160628580, 118160628581, 118160628583, 118160628564, 118160628565, 118160628566, 118160628567, 118160628571, 118160628572, 118160628573, 118160628582, 118160628574, 118160628575, 118160628576, 118340001391, 118340001392, 118340001393, 118340001394, 118340001395, 118340001396, 118340001397, 118340001388, 118340001389, 118340001390, 119110000129, 119110000130, 119110000132, 119110000133, 119110000134, 119110000135, 119110000136, 119110000137, 119130001327, 119130001328, 119130001331, 119110000128, 119110000131, 119130001329, 119130001330, 119170000064, 119170000066, 119170000067, 119170000068, 119190000633, 119190000634, 119190000635, 119190000629, 119190000630, 119190000636, 119190000637, 119170000054, 119170000061, 119190000628, 119190000631, 119190000632, 119170000055, 119170000056, 119170000062, 119170000063, 119170000065, 119170000057, 119170000058, 119170000059, 119170000060, 119240001197, 119240001198, 119340000071, 119340000072, 119340000073, 119340000074, 119340000075, 119340000076, 119340000077, 119340000078, 119340000079, 119340000080, 119350002675, 119350002676, 119350002677, 119350002678, 119350002679, 119350002680, 119350002681, 119350002682, 119350002683, 119350002684, 119380001144, 119380001145, 119380001146, 119380001147, 119380001148, 119380001149, 119430001324, 119430001325, 119430001326, 119430001327, 119430001328, 119430001329, 119430001330, 119430001331, 119430001332, 119430001333, 119470001107, 119470001108, 119470001109, 119470001110, 119470001111, 119470001112, 119470001113, 119470001114, 119470001115, 119470001116, 119500000427, 119500000428, 119500000429, 119500000430, 119500000431, 119500000432, 119500000433, 119500000434, 120080000436, 120080000437, 120080000438, 120080000439, 120080000440, 120080000441, 120080000442, 120080000443, 120080000444, 120080000445, 120080000446, 120080000447, 120080000448, 120080000449, 120080000450, 120080000451, 120080000452, 120080000453, 120080000454, 120080000455, 120260000436, 120260000437, 120260000438, 120370001869, 120370001870, 120370001872, 120260000439, 120260000440, 120370001871, 120370001873, 120370001874, 120370001875, 120370001876, 120370001877, 120370001878, 120410001420, 120410001421, 120410001422, 120410001423, 120410001424, 120410001425, 120410001426, 120410001427, 120480000382, 120480000383, 120480000384, 120480000385, 120480000386, 120480000387, 120480000388, 120480000389, 120480000390, 120480000391, 120480000392, 120480000393, 120480000394, 120480000395, 120520000178, 120520000179, 120520000180, 120520000181, 120520000182, 120520000183, 120520000184, 120520000185, 120520000186, 120520000187, 120520000188, 120520000189, 121060001022, 121060001023, 121060001024, 121060001025, 121060001026, 121060001027, 121060001028, 121060001029, 121060001030, 121060001031, 121080000918, 121080000919, 121080000920, 121080000921, 121080000922, 121080000923, 121080000924, 121130001105, 121130001106, 121130001107, 121130001108, 121130001109, 121130001110, 121130001111, 121130001112, 121130001113, 121130001114, 121130001115, 121130001116, 121130001117, 121130001118, 121130001119, 121140001520, 121140001521, 121140001522, 121140001523, 121140001524, 121170000316, 121170000317, 121170000318, 121170000319, 121170000320, 121170000321, 121170000322, 121170000323, 121170000324, 121170000325, 118050609197, 121210002553, 121210002554, 121210002555, 121210002556, 121210002557, 121210002558, 121210002559, 121210002560, 121210002561, 121210002562, 121250000651, 121250000652, 121250000653, 121250000654, 121250000655, 121250000656, 121250000657, 121250000658, 121250000659, 121250000660, 121250000661, 121250000662, 121300001879, 121300001880, 121300001881, 121300001882, 121300001883, 121300001884, 121300001885, 121300001886, 121300001887, 121300001888, 121320000722, 121320000723, 121320000724, 121320000725, 121320000726, 121320000727, 121320000728, 121320000729, 121390000580, 121390000581, 121390000582, 121390000583, 121390000584, 121390000585, 121390000586, 121390000587, 121390000588, 121390000589, 121390000590, 121390000591, 121430000457, 121430000458, 121430000459, 121430000460, 121430000461, 121430000462, 121430000463, 121430000464, 121430000465, 121430000466, 121430000467, 121430000468, 121450000127, 121450000128, 121460000618, 121490000525, 121490000526, 121490000527, 121490000528, 121490000529, 121490000530, 121490000531, 121490000532, 121490000533, 121490000534, 121490000535, 121490000536, 122130000539, 122130000540, 122130000541, 122130000542, 122130000543, 122130000544, 122130000545, 122130000546, 122190000029, 122190000030, 122190000031, 122190000032, 122190000033, 122190000034, 122200001921, 122200001922, 122200001923, 122200001924, 122200001925, 122200001926, 122200001927, 122200001928, 122200001929, 122200001930, 122200001931, 12200001930, 122240001466, 122240001467, 122240001468, 122240001469, 122240001470, 122240001471, 122230000033, 122230000036, 122230000039, 122230000040, 122230000042, 122230000044, 122230000037, 122230000038, 122230000041, 122230000043, 122230000034, 122260001174, 122260001175, 122260001176, 122260001177, 122260001178, 122260001179, 122280000876, 122280000877, 122280000878, 122280000879, 122280000880, 122280000881, 122340001204, 122340001205, 122340001206, 122340001207, 122390000370, 122390000371, 122390000372, 122390000373, 122390000374, 122390000375, 122420000196, 122420000197, 122420000198, 122420000199, 122420000200, 122420000203, 122420000192, 122420000193, 122420000194, 122420000195, 122420000201, 122420000202, 122450001786, 122450001787, 122450001788, 122450001789, 122450001790, 122450001791, 123100000063, 123100000069, 123100000070, 123100000071, 123100000064, 123100000065, 123100000066, 123100000067, 123100000068, 123130001066, 123130001067, 123210000710, 123210000711, 123340001553, 123340001554, 123320000551, 123320000552, 123370000077, 123370000078, 123370000079, 123370000080, 118050610039, 118180634937, 118050609198, 118180634937, 121450000127, 121450000128, 121460000618, 122230000033, 122230000034, 122230000035, 122230000036, 122230000037, 122230000038, 122230000039, 122230000040, 122230000041, 122230000042, 122230000043, 122230000044, 122500000829, 122500000830, 122500000831, 116480540886, 116480540887, 116480540885, 116480540888, 116480540889, 116480540890, 116480540891, 116500543972, 116530547195, 116530547196, 116530547197, 116530547198, 116530547199, 116530547200, 116530547201, 116530547207, 116530547208, 116530547209, 116530547202, 116530547203, 116530547204, 116530547205, 116530547206, 117050552991, 117050552992, 117140561292, 117140561293, 117140561294, 117140561295, 117140561296, 117140561297, 117140561299, 117140561300, 117140561301, 117140561302, 117190567099, 117190567100, 117140561298, 117190567101, 117190567102, 117190567103, 117190567104, 117190568321, 117190568322, 117190568323, 117210570066, 117250575592, 117250575593, 117250575594, 117250575595, 117250575596, 117250575597, 117260576261, 117260576262, 117260576263, 117250575598, 117250575599, 117250575600, 117250575601, 117310581178, 117310581179, 117350584646, 117350584647, 117350584648, 117350584649, 117350584650, 117350584642, 117350584643, 117400589264, 117400589265, 117400589266, 117400589267, 117400589268, 117400589293, 117400589294, 117400589295, 117400589296, 117400589297, 117400589298, 117400589299, 117400589269, 117400589270, 117400589271, 117400589272, 117400589273, 117400589274, 117430591637, 117430591638, 117430591639, 117430591640, 117430591980, 117430591981, 117490599622, 117490599623, 117490599624, 117490599625, 117490599627, 117490599628, 117490599630, 117490599619, 117490599620, 117490599621, 117490599626, 117490599629, 117490599631, 117490599632, 117490599633, 117510602851, 117510602852, 117510602853, 117510602854, 117520603151, 117520603152, 117520603153, 117520603154, 118030606983, 118030606984, 118030606985, 118030606986, 118030606987, 118030606988, 118030606989, 118030606990, 118030606991, 118030606992, 118050609193, 118050609194, 118050609195, 118050609196, 118050609199, 118050609200, 118050609201, 118050609202, 118060611433, 118060611429, 118060611430, 118060611431, 118060611432, 118060611434, 118060611435, 118060611437, 118060611440, 118080615016, 118080615015, 118080615014, 118080615012, 118080615010, 118080615009, 118080615008, 118080615007, 118080615006, 118080615005, 118080615004, 118080615003, 118060611448, 118060611446, 118060611445, 118060611444, 118060611443, 118060611442, 118060611441, 41000-030-60, 118180634941, 118180634942, 118340001398, 118340001399, 118340001400, 118340001401, 118340001402, 118340001403, 118340001404, 118340001405, 118340001406, 118340001407, 118340001408, 118340001409, 118340001410, 118340001411, 118340001412, 120180001027, 120180001028, 120180001029, 120180001030, 120180001031, 10081765502005100, 121040002235, 121040002236, 121040002237, 121040002238, 121040002239, 121040002240, 121040002241, 121040002242, 121040002243, 121040002244, 121050001674, 121050001675, 121050001676, 121050001677, 121050001678, 121050001679, 121050001680, 121050001681, 121050001682, 121050001683, 121080000925, 121080000926, 121080000927, 122200001932, 10081765502005100, 123390000815, 123390000816, 123390000817, 123390000818, 123400000181, 123400000182, 123400000183, 123400000184, 123420000969, 123420000970, 123420000971, 123420000972, 123430002087, 123440000214, 123440000215, 123440000216, 123440000217, 123450001456, 123450001457, 123450001458, 123450001459, 123480000269, 123480000270, 123480000271, 123480000272;  f) 41000-030-62, UDI/DI 00817655020068, Serial Numbers:  118160628584, 118160628585, 118320000033, 118330000323, 118330000325, 118320000032, 118330000324, 118330000326, 118330000320, 118330000321, 118330000322, 118450000081, 118450000082, 118330000319, 118470000102, 118470000406, 118470000407, 118470000408, 118480000446, 118480000447, 118480000448, 118480000449, 118500001826, 118500001827, 118500001834, 118500001835, 118500001828, 118500001830, 118500001829, 118500001831, 118500001832, 119190000641, 119190000642, 119190000638, 119190000639, 119190000640, 118500001825, 118500001833, 119250001407, 119320001005, 119320001006, 119320001007, 119320001002, 119320001003, 119320001004, 119350002522, 119350002523, 119350002524, 119350002525, 119430001320, 119430001321, 119430001322, 119430001323, 119430001318, 119430001319, 119470002142, 119470002144, 119470002146, 119470002143, 119470002145, 119470002147, 120040000343, 120040000344, 120050001743, 120050001744, 120050001745, 120080000456, 120080000457, 120080000458, 120080000459, 120080000460, 120080000461, 120080000462, 120080000463, 120080000464, 120080000465, 120080000466, 120080000467, 120080000468, 120080000469, 120080000470, 120080000471, 120080000472, 120080000473, 120080000474, 120330000674, 120330000676, 120050001744, 120050001745, 120330000671, 120330000672, 120330000673, 120330000675, 120330000677, 120330000678, 120330000679, 120330000680, 120050001743, 120480000397, 120480000396, 120520000680, 120520000681, 120520000682, 121060001019, 121060001020, 121060001021, 121080000928, 121080000929, 121130001120, 121130001121, 121130001122, 121170000326, 121170000327, 121170000328, 121210002563, 121210002564, 121210002565, 121250000663, 121250000664, 121250000665, 121300001889, 121300001890, 121300001891, 121340000858, 121340000859, 121340000860, 121420001162, 121420001163, 121420001164, 121420001165, 121470000236, 121470000237, 121470000238, 121510001415, 121510001416, 121510001417, 122050001914, 122050001915, 122050001916, 122080000224, 122080000225, 122080000226, 122130000547, 122130000548, 122130000549, 122240001057, 122240001061, 122240001062, 122240001058, 122240001059, 122240001060, 122240001063, 122310000395, 122310000396, 122310000397, 122320000145, 122320000146, 122320000147, 122320000881, 122320000882, 122320000883, 122380000624, 122380000625, 122380000626, 122450001792, 122450001793, 122450001794, 122480001906, 122480001909, 123020001482, 123020001483, 123070001510, 123070001513, 123070001514, 123070001515, 123100001935, 123100001936, 123070001509, 123070001511, 123070001512, 123190000747, 123190000749, 123150002638, 123190000748, 123200000231, 123150002639, 123220001435, 123220001436, 123300001463, 123300001464, 123300000098, 123300000099, 123370000075, 123370000076, 122480001907, 122480001908, 123320000988, 123300001462, 123320000989, 123320000986, 123320000987, 120050001743, 120050001744, 120050001745, 120330000674, 120330000676, 120480000396, 113400177568, 116480540898, 116530547192, 116530547193, 116530547194, 117010549589, 117010549590, 117110556514, 117110556515, 117110556516, 117130560456, 117130560457, 117130560458, 117150562750, 117150562748, 117150562749, 117180567076, 117180567077, 117190568320, 117210570063, 117210570064, 117210570065, 117260575996, 117260575997, 117260575998, 117310581180, 117310581181, 117350584629, 117350584630, 117350584631, 117350584632, 117350584633, 117400589290, 117400589291, 117400589292, 117430592542, 117430592543, 117430592544, 117490599636, 117490599637, 117490599639, 117490599634, 117490599635, 117490599638, 118070612685, 118070612687, 118070612686, 118080614439, 118080614440, 118090617067, 118090617068, 118090617071, 118090617070, 118090617069, 118160628588, 118160628587, 118160628586, 118160628589, 118160628590, 118320000034, 118320000035, 118330000327, 118330000328, 118330000329, 120040000345, 120040000346, 120040000347, 120480000398, 120480000399, 120480000400, 120480000401, 120480000402, 120480000403, 120480000404, 120480000405, 120480000406, 120480000407, 120480000408, 123400000068, 123400000069;  g) 41000-030-64, UDI/DI 00817655021423, Serial Numbers:  119490000440, 119500001335, 121350001043, 120070000730, 119490000439, 120070000732, 118380003022, 118380003023, 118470000103, 118470000104, 119500001336, 118380003022, 118380003023, 118470000103, 118470000104, 120070000731, 123150002068, 123150002069, 123150002070, 123160000556, 123150002055, 123200001669, 123150002057, 123150002058, 123200001670, 123200001671, 123150002066, 123150002067, 120070000733, 123150002056, 123150002061, 123150002062, 123150002063, 123150002064, 123150002065, 123150002059, 123150002060, 123160000552, 123160000553, 123160000554, 123160000555, 119500001335, 121350001043, 120070000730, 119490000439, 120070000732, 117320582006, 120070000734, 120070000735, 120070000736, 120070000737, 11847000104, 120070000738, 120070000739, 121350001044, 121350001045.

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

United States (including Puerto Rico), Canada, Australia, Bangladesh, Brunei, Chia, Hong Kong, India, Indonesia, Korea, Malaysia, New Zealand, Philippines, Singapore, Sri Lanka, Thailand, Algeria, Angola, Austria, Bahrain, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Hungary, Iceland, Iran, Iraq, Ireland, Israel, Italy, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Morocco, Namibia, Netherlands, Norway, Oman, Pakistan, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, South Africa, Spain, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Argentina, Bahamas, Bolivia, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, Guatemala, Honduras, Mexico, Panama, Paraguay, Peru, and Trinidad and Tobago.

Recall record

Recalling firm
Baxter Healthcare Corporation
Product type
Devices
Recall number
Z-0706-2024
Voluntary / mandated
Voluntary: Firm initiated
Initial notification
Letter
Origin
Deerfield, IL
Recall initiated
2023-12-08

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-0706-2024 · Source: openFDA enforcement.