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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89280

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 22, 2021
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Xomed, Inc.

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

1 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 1

NIM TRIVANTAGE EMG Endotracheal Tube

Z-0743-2022
Recall number
Z-0743-2022
Initiated
December 22, 2021
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Xomed, Inc.
Quantity
301,926 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for multiple issues due to a manufacturing nonconformity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is potential for multiple issues due to a manufacturing nonconformity.

Code information

Products: 1) Product Number 8229705 (GTIN 00763000033934); Lots: 0218762694, 0218663943, 0219904500, 0220293429, 0220584798, 0220756285, 0220774358, 0221736070, 0221805033, 0222186741, 0222495993, 0222591367 2) Product Number 8229706 (GTIN 00763000033941); Lots: 0218663944, 0218664146, 0218762695, 0218762699, 0218762698, 0218762697, 0219010138, 0219010139, 0219010142, 0219010140, 0219010141, 0219278186, 0219272545, 0219278189, 0219278188, 0219278190, 0219444156, 0219444157, 0219278187, 0219444160, 0219444158, 0219444159, 0219444161, 0219836614, 0219972527, 0219969085, 0219972526, 0219972528, 0219836616, 0220087597, 0220087596, 0220087598, 0220293430, 0220293432, 0220293434, 0220293431, 0220293433, 0220293435, 0220371534, 0220371535, 0220371537, 0220371536, 0220517619, 0220517618, 0220584803, 0220584804, 0220734720, 0220769468, 0220769470, 0220878556, 0220769469, 0220878557, 0220934885, 0221123594, 0221123639, 0221248868, 0221248867, 0221248869, 0221493241, 0221543453, 0221543452, 0221637121, 0221637122, 0221710524, 0221805030, 0221805031, 0221805039, 0221805041, 0222048142, 0222024594, 0222057391, 0222140123, 0222200982, 0222200983, 0222200984, 0222239875, 0222239874, 0222352848, 0222396630, 0222428754, 0222465659, 0222495994, 0222495995, 0222495996, 0222542347, 0222542348, 0222563000, 0222563288, 0222738659, 0222719941, 0222684388 3) Product Number 8229707 (GTIN 00763000033958); Lots: 0218664151, 0218664148, 0218664149, 0218664157, 0218664156, 0218664155, 0218664150, 0218664154, 0218664158, 0218664153, 0218664152, 0218762700, 0218762705, 0218762701, 0218762704, 0218762703, 0218762806, 0218762702, 0218762807, 0218762812, 0218762809, 0218762814, 0218762815, 0219010143, 0219010144, 0219010145, 0219010806, 0219010807, 0219010809, 0219010813, 0219010811, 0219010810, 0219010808, 0219010812, 0219010814, 0219010816, 0219010818, 0219010819, 0219010817, 0219010820, 0219010815, 0219010821, 0219010822, 0219278191, 0219444374, 0219444375, 0219444376, 0219278193, 0219278196, 0219278195, 0219278192, 0219278197, 0219278194, 0219444369, 0219444370, 0219278198, 0219444371, 0219952959, 0219444372, 0219985176, 0219444373, 0219985177, 0219723502, 0219952958, 0220033883, 0220033885, 0220037915, 0220047459, 0220047460, 0220057008, 0220057009, 0220057010, 0220057011, 0220076607, 0220081032, 0220081037, 0220008824, 0220008823, 0220010546, 0220010547, 0220008825, 0220010548, 0220087591, 0220087602, 0220087599, 0220087601, 0220087600, 0220087603, 0220142052, 0220087886, 0220142053, 0220142054, 0220142055, 0220142060, 0220149776, 0220149778, 0220230467, 0220230468, 0220230472, 0220230469, 0220142057, 0220142058, 0220142059, 0220149779, 0220142063, 0220142064, 0220142062, 0220142065, 0220370784, 0220370785, 0220371526, 0220371528, 0220371527, 0220371530, 0220371529, 0220371531, 0220371532, 0220371533, 0220517189, 0220517190, 0220517620, 0220517621, 0220517191, 0220517193, 0220517194, 0220517192, 0220517195, 0220517196, 0220517197, 0220517199, 0220517200, 0220517198, 0220517201, 0220517202, 0220622252, 0220622253, 0220637407, 0220637408, 0220637409, 0220637410, 0220688264, 0220688265, 0220691509, 0220691510, 0220734718, 0220756281, 0220756282, 0220756283, 0220756284, 0220769471, 0220804919, 0220769472, 0220798476, 0220813969, 0220813970, 0220817687, 0220817686, 0220826216, 0220826217, 0220845825, 0220846126, 0220857889, 0220878558, 0220878559, 0220878561, 0220878560, 0220878562, 0220878563, 0220913062, 0220935486, 0220935487, 0220935488, 0220935489, 0220974382, 0221040035, 0221056071, 0221040036, 0221056072, 0221082044, 0221069155, 0221082126, 0221073627, 0221090328, 0221090327, 0221097604, 0221097605, 0221098067, 0221098066, 0221118571, 0221118572, 0221123591, 0221123638, 0221146333, 0221146457, 0221146458, 0221146460, 0221146459, 0221146461, 0221146462, 0221146463, 0221146879, 0221146889, 0221146901, 0221248875, 0221248876, 0221248877, 0221248878, 0221248879, 0221248880, 0221248881, 0221248882, 0221248883, 0221248884, 0221248885, 0221378722, 0221378724, 0221378725, 0221379386, 0221379387, 0221379388, 0221493665, 0221493866, 0221514981, 0221526915, 0221526917, 0221526918, 0221526920, 0221526919, 0221571421, 0221599118, 0221599117, 0221599181, 0221599119, 0221651974, 0221637118, 0221656119, 0221656118, 0221659143, 0221659144, 0221736003, 0221736005, 0221766209, 0221766208, 0221766211, 0221736786, 0221805043, 0221772984, 0221886337, 0221805044, 0221893434, 0221893435, 0221897719, 0221897720, 0221893433, 0221924396, 0221931540, 0221938902, 0221938901, 0221962166, 0221967955, 0222057392, 0222024589, 0222069694, 0222093329, 0222069692, 0222069693, 0222093330, 0222101075, 0222110921, 0222110922, 0222136940, 0222106107, 0222139599, 0222139600, 0222140118, 0222140119, 0222140125, 0222140446, 0222163047, 0222140120, 0222168488, 0222168489, 0222168491, 0222168492, 0222168493, 0222202227, 0222202226, 0222202228, 0222202230, 0222202231, 0222239881, 0222202232, 0222239878, 0222239882, 0222239883, 0222239884, 0222240046, 0222240047, 0222239885, 0222202229, 0222312293, 0222312878, 0222334222, 0222334223, 0222334220, 0222334221, 0222358414, 0222334224, 0222358415, 0222358416, 0222358417, 0222358418, 0222396631, 0222396632, 0222396634, 0222396633, 0222396635, 0222456848, 0222456849, 0222456850, 0222456851, 0222456852, 0222476127, 0222476128, 0222476130, 0222476131, 0222476129, 0222495997, 0222495998, 0222495999, 0222496000, 0222496001, 0222496002, 0222496003, 0222542350, 0222542349, 0222542352, 0222542351, 0222542353, 0222563004, 0222563286, 0222684391, 0222684395, 0222684394, 0222738663, 0222738660, 0222738661, 0222563287, 0222719938, 0222719943, 0222720028, 0222719945, 0222563002, 0222684393, 0222738665, 0222738664, 0222720029, 0222684392, 0222563001, 0222563005, 0222857893, 0222563003, 0222857891, 0222857894, 0222857892, 0222857896, 0222857895, 0222857897, 0222857898, 0222857900, 0222738662, 0222719944 4) Product Number 8229708 (GTIN 00763000033965); Lots: 0218664160, 0218664159, 0218664163, 0218664161, 0218664162, 0218762816, 0218762821, 0218762820, 0218762818, 0218762819, 0218762822, 0219278200, 0219278201, 0219278199, 0219278202, 0219444162, 0219444163, 0219444165, 0219444164, 0220087592, 0220087593, 0220087594, 0220087595, 0220142108, 0220142106, 0220142109, 0220293438, 0220293439, 0220228325, 0220142110, 0220293440, 0220517617, 0220517616, 0220658898, 0220517614, 0220517615, 0220370781, 0220142111, 0220730554, 0220370782, 0220370783, 0220855164, 0220855449, 0220855447, 0220873204, 0220855448, 0220935503, 0220935651, 0220935648, 0220935505, 0220935654, 0221056080, 0221056081, 0221097602, 0221097603, 0221146446, 0221146343, 0221146448, 0221146951, 0221146936, 0221248874, 0221378720, 0221588082, 0221588083, 0221637123, 0221710525, 0221710926, 0221851581, 0221851580, 0221893436, 0221931647, 0221931648, 0222031317, 0222081991, 0222101073, 0222140122, 0222140121, 0222217071, 0222240048, 0222302776, 0222358419, 0222358421, 0222396636, 0222396637, 0222456853, 0222456854, 0222476133, 0222542354, 0222563290, 0222720030, 0222739006 5) Product Number 8229709 (GTIN 00763000033972); Lots: 0222248291, 0218452814, 0218540733, 0218540734, 0218540735, 0218452815, 0218515807, 0218275886, 0218275305, 0218496850, 0219906760, 0220586086, 0220973095, 0221248873, 0221517237, 0221805028, 0222187092, 0222336506 6) Product Number 8229735 (GTIN 20763000041506); Lots: 0218275302, 0220584797, 0220883592, 0221996821, 0222146974 7) Product Number 8229736 (GTIN 20763000041513); Lots: 0221246105, 0218762830, 0218762829, 0219010518, 0219010517, 0219010516, 0219904499, 0219985174, 0220293436, 0220293437, 0220584799, 0220880266, 0220998690, 0221038763, 0221248866, 0221378719, 0221543451, 0221805267, 0222024592, 0222140124, 0222240053, 0222527962, 0222684399 8) Product Number 8229737 (GTIN 20763000041520); Lots: 0222908102, 0218762831, 0218762833, 0218762832, 0218762835, 0218762834, 0219010519, 0219733959, 0219744709, 0219788607, 0219785665, 0219795301, 0219788608, 0219795296, 0219795302, 0219795303, 0219802959, 0219802960, 0219836612, 0219836613, 0219904496, 0219904497, 0219972534, 0219972535, 0219972536, 0219972537, 0219985178, 0219972538, 0219802958, 0220010550, 0220010551, 0220010554, 0220010552, 0220010555, 0220087604, 0220087605, 0220142112, 0220142116, 0220142113, 0220142114, 0220230480, 0220228945, 0220230481, 0220230426, 0220230427, 0220230428, 0220230429, 0220230430, 0220293443, 0220293444, 0220293442, 0220713083, 0220734719, 0220734721, 0220769475, 0220769474, 0220769476, 0220785122, 0220790899, 0220826214, 0220847263, 0220826215, 0220857890, 0221010990, 0220998691, 0221034442, 0221035008, 0221038764, 0221056079, 0221248870, 0221248871, 0221248872, 0221378718, 0221463272, 0221463273, 0221493867, 0221493869, 0221493238, 0221493240, 0221543449, 0221637119, 0221637120, 0221718467, 0221766210, 0221805034, 0221805035, 0221805037, 0221805038, 0221924395, 0221910040, 0221967715, 0221931646, 0222024596, 0222024590, 0222024595, 0222034111, 0222034109, 0222065770, 0222119577, 0222123196, 0222187098, 0222334225, 0222358420, 0222396638, 0222456855, 0222496004, 0222496005, 0222739007, 0222563291, 0222684396, 0222719939, 0222720026, 0222739008, 0222562999, 0222542355, 0010791039 9) Product Number 8229738 (GTIN 20763000041537); Lots: 0218762837, 0218762838, 0218762840, 0218762842, 0218762841, 0219011550, 0219011551, 0219011552, 0219861141, 0219878783, 0219861136, 0219878782, 0219878784, 0219879026, 0219952951, 0219952952, 0220142117, 0220142118, 0220142119, 0220142120, 0220142121, 0220855453, 0220966544, 0221038762, 0221146339, 0221247365, 0221463276, 0221514982, 0221543448, 0221765700, 0221898348, 0222007804, 0222031318, 0222187101, 0222476134, 0222739009, 0222542356, 0222684398 10) Product Number 8229739 (GTIN 20763000041544); Lots: 0218762824, 0220584805, 0222024591, 0222272928, 0222476135

Distribution pattern

Worldwide distribution - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Faroe Islands, Finland, France, French Guinea, Germany, Greece, Guadeloupe, Guam, Guatemala, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Korea (Republic of), Kuwait, Lebanon, Libya, Luxembourg, Malaysia, Mauritius, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Caledonia, New Zealand, North Macedonia, Norway, Panama, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, and Vietnam.

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