Recall archive / FDA device enforcement

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ... — FDA record Z-1728-2022

Reported ongoing

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

Source date Aug 11, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

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

What the record says

Product: GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMATCH GXL 0 DEGREE LINER 28MM SZ F, REF 130-28-26 c. ACUMATCH GXL 0 DEGREE LINER 28MM SZ G, REF 130-28-27 d. ACUMATCH GXL 0 DEGREE LINER 28MM SZ H, REF 130-28-28 e. ACUMATCH GXL 0 DEGREE LINER 28MM SZ J, REF 130-28-29 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ G, REF 130-32-27 g. ACUMATCH GXL 0 DEGREE LINER 32MM SZ H, REF 130-32-28 f. ACUMATCH GXL 0 DEGREE LINER 32MM SZ J, REF 130-32-29 g. ACUMATCH GXL 0 DEGREE LINER 36MM SZ H, REF 130-36-28 h. ACUMATCH GXL 0 DEGREE LINER 36MM SZ J, REF 130-36-29 i. ACUMATCH GXL 0 DEGREE LINER 36MM SZ K, REF 130-36-30 j. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ E, REF 138-28-25 k. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ F, REF 138-28-26 l. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ G, REF 138-28-27 m. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ H, REF 138-28-28 n. ACUMATCH GXL 15 DEG +5 LAT LINER 28MM SZ J, REF 138-28-29 o. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ H, REF 138-36-28 p. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ J, REF 138-36-29 q. ACUMATCH GXL 15 DEG +5 LAT LINER 36MM SZ K, REF 138-36-30 r. ACUMATCH GXL 15 DEG +5 LAT LINER SZG 38MM, REF 138-36-27 s. ACUMATCH GXL 15DEG LINER 28MM SZ D, REF 132-28-24 t. ACUMATCH GXL 15DEG LINER 28MM SZ E, REF 132-28-25 u. ACUMATCH GXL 15DEG LINER 28MM SZ F, REF 132-28-26 v. ACUMATCH GXL 15DEG LINER 28MM SZ G, REF 132-28-27 w. ACUMATCH GXL 15DEG LINER 28MM SZ H, REF 132-28-28 x. ACUMATCH GXL 15DEG LINER 28MM SZ J, REF 132-28-29 y. ACUMATCH GXL 15DEG LINER 28MM SZ K, REF 132-28-30 z. ACUMATCH GXL 15DEG LINER 32MM SZ G, REF 132-32-27 aa. ACUMATCH GXL 15DEG LINER 32MM SZ H, REF 132-32-28 bb. ACUMATCH GXL 15DEG LINER 32MM SZ J, REF 132-32-29 cc. ACUMATCH GXL 15DEG LINER 32MM SZ K, REF 132-32-30 dd.ACUMATCH GXL 15DEG LINER 36MM SZ H, REF 132-36-28 ee. ACUMATCH GXL 15DEG LINER 36MM SZ J, REF 132-36-29 ff. ACUMATCH GXL 15DEG LINER 36MM SZ K, REF 132-36-30 gg. ACUMATCH GXL EXT COV LINER 28MM SZ E, REF 134-28-25 hh. ACUMATCH GXL EXT COV LINER 28MM SZ F, REF 134-28-26 ii. ACUMATCH GXL EXT COV LINER 28MM SZ G, REF 134-28-27 jj. ACUMATCH GXL EXT COV LINER 28MM SZ H, REF 134-28-28 kk. ACUMATCH GXL EXT COV LINER 28MM SZ J, REF 134-28-29 ll. ACUMATCH GXL EXT COV LINER 28MM SZ K, REF 134-28-30 mm. MCS GXL LINER 5/15 DEG 4448X28, REF 104-28-43 nn. MCS GXL LINER 5/15 DEG 5052X28, REF 104-28-44 oo. MCS GXL LINER 5/15 DEG 5458X28, REF 104-28-45 pp. MCS GXL LINER 5/15 DEG 5458X32, REF 104-32-45 qq. MCS GXL LINER 5/15 DEG 6064X32, REF 104-32-46 rr. MCS GXL LINER 5/15 DEG 6064X36, REF 104-36-46 ss. MCS GXL LINER 5/15 DEG 6670X36, REF 104-36-47
Reason: Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
Classification: Class II
Recalling firm: Exactech, Inc.
Quantity: 11143 DEVICES
Agency-reported status: Ongoing
Source record identifier: Z-1728-2022

Open the official record

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

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	a. REF 130-28-25, GUDID 10885862021984, Serial Numbers: 802593, 802599, 803717, 803737, 841318, 841321, 1572107, 1579369, 1580046, 1583363, 1613871, 1613872, 1613873, 1618998, 1638490, 1638492, 1638494, 1990100, 2282432, 2282433, 2282434; b. REF 130-28-26, GUDID 10885862021991, Serial Numbers: 801865, 801867, 801870, 801872, 801882, 801883, 801886, 801902, 803686, 803690, 803691, 803694, 803695, 803701, 848210, 848213, 848217, 848221, 848222, 848223, 848226, 848232, 848233, 848236, 1677105, 1677106, 1677108, 1677109, 1677110, 1677112, 1677113, 1677114, 1677115, 1677116, 1677118, 1677119, 1677121, 1677122, 1677123, 1677124, 1677126, 1677127, 1677128, 1677129, 1677130, 1677131, 2515330, 2787553, 3871934, 3871935, 3871943; c. REF 130-28-27, GUDID 10885862022004, Serial Numbers: 801542, 801544, 801546, 801547, 801554, 801571, 801572, 801578, 801580, 804033, 804034, 804035, 804036, 862139, 862144, 862146, 1681578, 1681579, 1681580, 1681581, 1681583, 1703643, 1727491, 1727492, 1727493, 1727495, 1727496, 1727497, 1727498, 1727499, 1727500, 1727501, 1727502, 1727503, 1727504, 1727505, 1727506, 1727507, 1727508; d. REF 130-28-28, GUDID 10885862022011, Serial Numbers: 801765; e. REF 130-28-29, GUDID 10885862022028, Serial Numbers: 801654; f. REF 130-32-27, GUDID 10885862022097, Serial Numbers: 966203, 966204, 966205, 966207, 966208, 966209, 966210, 966211, 966212, 966213, 966215, 966216, 966217, 966218, 966219, 966220, 966221, 966222, 966223, 966224, 966225, 966226, 966227, 966228, 966229, 966230, 966231, 966232, 966233, 1042377, 1042378, 1042379, 1042381, 1042382, 1042383, 1042384, 1042385, 1042387, 1042388, 1042391, 1042392, 1042394, 1042395, 1042396, 1042397, 1042398, 1042399, 1042400, 1042401, 1042402, 1042405, 1042406, 1042407, 1042408, 1095431, 1095432, 1095433, 1095434, 1095435, 1095436, 1095437, 1095438, 1095439, 1095440, 1095441, 1095443, 1095444, 1095445, 1095446, 1095447, 1095448, 1095449, 1095537, 1095538, 1095539, 1095541, 1095542, 1095545, 1095546, 1095547, 1095548, 1095550, 1308088, 1308090, 1308092, 1308093, 1308094, 1308095, 1308096, 1308098, 1308102, 1308103, 1308104, 1308105, 1308106, 1308109, 1308111, 1308113, 1308115, 1308116, 1308117, 1308118, 1308119, 1308120, 1984610, 1984611, 1984612, 1984613, 1984614, 1984616, 2053081, 2075035, 2075037, 2075038, 2075039, 2075040, 2075041, 2075042, 2075043, 2075044, 2075045, 2075046, 2075048, 2075049, 2075050, 2075051, 2398494, 2398496, 2398499, 2517474, 2517476, 2517478, 3818434, 3818437, 3818439, 3818444, 3818447; g. REF 130-32-28, GUDID 10885862022103, Serial Numbers: 966299, 966302, 966305, 966307, 966308, 966312, 966313, 966316, 966317, 966318, 966321, 966322, 966327, 1090743, 1090745; f. REF 130-32-29, GUDID 10885862022110, Serial Numbers: 969025, 969026, 969031, 969043; g. REF 130-36-28, GUDID 10885862022202, Serial Numbers: 967669, 967670, 967671, 967672, 967673, 967674, 967675, 967676, 967677, 967678, 967680, 967681, 967683, 967684, 967685, 967686, 967687, 967688, 967689, 967690, 967691, 967692, 967693, 967694, 967695, 967698, 967699, 967700, 967701, 1051661, 1051662, 1051663, 1051664, 1051665, 1051666, 1051667, 1051669, 1051670, 1085957, 1085959, 1085960, 1085961, 1085962, 1085963, 1085964, 1085965, 1085966, 1116002, 1116003, 1116005, 1116006, 1116007, 1116008, 1116009, 1116010, 1116011, 1116012, 1160079, 1160080, 1160081, 1160082, 1160083, 1160084, 1160085, 1160086, 1160087, 1160089, 1206218, 1206219, 1206223, 1206224, 1206225, 1206226, 1668596, 1668597, 1668598, 1668599, 1668600, 1668601, 1668602, 1668603, 1668604, 1668605, 2112376, 2112377, 2112381, 2112382, 2112383, 2112384, 2140027, 2140028, 2504302, 2537040, 2710341, 3871865, 4984351; h. REF 130-36-29, GUDID 10885862022219, Serial Numbers: 975034, 975035, 975036, 975037, 975038, 975040, 975041, 975042, 975043, 975044, 975046, 975047, 975048, 975049, 975050, 975053, 975054, 975055, 975057, 975059, 975063, 1111355, 1111357, 1111358, 1111359, 1111361, 1121576, 1121578, 1121584, 1300472, 1300476, 1300477, 1984741, 1984743, 1984744, 3877076, 3877077, 3877094; i. REF 130-36-30, GUDID 10885862022226, Serial Numbers: 1880259, 1880260, 1880261, 1880262, 1880263, 1880264, 1880265, 1880266, 1880267, 1880268; j. REF 138-28-25, GUDID 10885862024589, Serial Numbers: 805443, 805445, 830281, 830311, 1093756, 1093757, 1632712, 1632713, 1632714, 1632715, 1632716, 1632717, 1662735, 1662736, 1662737, 1667712, 1667715, 1667716, 1667717, 1667718, 1667723, 1667725, 1667726, 1667727, 1667728, 3873889; k. REF 138-28-26, GUDID 10885862024596, Serial Numbers: 805410, 805413, 805421, 805431, 830169, 830177, 830179, 830183, 830184, 830203, 830207, 830209, 830214, 1063813, 1063818, 1063821, 1063830, 1063831, 1737026, 1737027, 1737028, 1737029, 1737030, 1737031, 1737032, 1737033, 2042361, 2042363, 2042364, 2042366, 2042369, 2042372, 2042373, 3840141; l. REF 138-28-27, GUDID 10885862024602, Serial Numbers: 805797, 805799, 805802, 805805, 805806, 805807, 805809, 805810, 805811, 805812, 805816, 805818, 805819, 805820, 805821, 825944, 825949, 825951, 825956, 825961, 825967, 825969, 825970, 825973, 825977, 825978, 825982, 825987, 1063928, 1063941, 2077678, 2077685, 2089964, 3641016, 3873936, 3949986, 3949987; m. REF 138-28-28, GUDID 10885862024619, Serial Numbers: 805355, 805363, 805370, 826263, 826270, 826272, 826275, 1063978; n. REF 138-28-29, GUDID 10885862024626, Serial Numbers: 805827, 805831, 826312, 1063872, 1063889; o. REF 138-36-28, GUDID 10885862024824, Serial Numbers: 807111, 807112, 807113, 807114, 807116, 807119, 807120, 807121, 807122, 807123, 807124, 807125, 807126, 807127, 807128, 807129, 832731, 832732, 832733, 832734, 832735, 832736, 832737, 832738, 832739, 832740, 832742, 832745, 832747, 832748, 832750, 832752, 832754, 832756, 832757, 832758, 832759, 832761, 832763, 832764, 832765, 832767, 832768, 832769, 832770, 832771, 832772, 832773, 832774, 832775, 1019498, 1019499, 1019500, 1019501, 1062910, 1062911, 1062912, 1062913, 1062915, 1062917, 1062918, 1062919, 1062925, 1062927, 1062928, 1223016, 1223017, 1223018, 1223019, 1223022, 1223024, 1223025, 1223026, 1223030, 1223032, 1223033, 1223035, 1223038, 1223039, 1223041, 1900707, 1900708, 1900709, 1900710, 1900711, 1900712, 1920463, 1920464, 1920466, 1920467, 1920468, 1920469, 1920470, 1920471, 1973173, 1973174, 1973175, 1973176, 1973177, 2042392, 2042394, 2313822, 2515477, 2515478, 2800310, 2914514, 2914515, 2914516, 2914517, 2914519, 2914520, 4127080, 4127085, 4127087, 4127089; p. REF 138-36-29, GUDID 10885862024831, Serial Numbers: 807004, 807006, 807013, 807014, 807015, 807017, 807018, 807022, 832683, 832684, 832685, 832686, 832687, 832688, 832690, 832692, 832693, 832694, 832695, 832697, 832698, 832699, 832700, 832706, 832715, 832716, 832717, 832718, 832722, 832723, 832724, 832730, 1086653, 1086658, 1086660, 1086662, 1086665, 1086666, 1086668, 1086672, 1086673, 1636898, 1636900, 1636905, 1636906, 1636908, 1636912, 2102752, 2102757, 2102768, 4127096; q. REF 138-36-30, GUDID 10885862024848, Serial Numbers: 1601226, 1619050, 1619053, 1619054, 1619055. 1619056, 1781527; r. REF 138-36-27, GUDID 10885862024817, Serial Numbers: 1803304; s. REF 132-28-24, GUDID 10885862023063, Serial Numbers: 774713, 775770, 780332, 780345, 780350, 780361, 832888, 832889, 832892, 832893, 832895, 832896, 832897, 832898, 832899, 832907, 832910, 832911, 832913, 832916, 832917, 832918, 832919, 832920, 832921, 832927, 832928, 1425136, 1425137, 1425138, 1425139, 1425140, 1425141, 1425142, 1425143, 1425144, 1461022, 1461023, 1461024, 1461025, 1461026, 1461027, 1461028, 1461029, 1461030, 1461031, 1468006, 1468007, 1468008, 1468011, 1468013, 1500600, 1500601, 1500604, 1500605, 1500606, 1500607, 1506186, 1506187, 1506189, 1506191, 1506193, 1506709, 1506711, 1506712, 1506713, 1506715, 1539850, 1539851, 1547645, 1547646, 1547647, 1547650, 1553669, 1553670, 1553671, 1553673, 1583122, 1583123, 1583124, 1606151, 1606152, 1606155, 1606156, 1606162, 1606163, 1606164, 1606165, 1606166, 1606167, 1606169, 1606170, 1606173, 1606174, 1606175, 1726208, 1726209, 1726211, 1726212, 1726213, 1726214, 1726216, 1726217, 1726218, 1726219, 1726220, 1726221, 1726222, 1726224, 1726225, 1726226, 1726227, 1726228, 1726229, 1726230, 1726232, 1726233, 1726234, 1797506, 1797509, 1797510, 1797511, 1797513, 1797515, 1797516, 1797519, 1797520, 1797521, 1797522, 1797523, 1797524, 1797525, 1797527, 1797528, 1857368, 1857369, 1857370, 1945042, 1945043, 1945044, 1945046, 1945047, 1945048, 1945049, 1945052, 1945054, 1945055, 1945056, 1945057, 1945058, 1945059, 1945061, 1945062, 2420338, 2420339, 2420340, 2420341, 2420342, 2420343, 2574499, 2574500, 2574501, 2574502, 2574503, 2574504, 2574505, 2673229, 2673231, 2673233, 2673235, 2673236, 2673237, 2673238, 2673239, 2673240, 2767967, 2767981, 3863516; t. REF 132-28-25, GUDID 10885862023070, Serial Numbers: 772272, 772273, 772274, 772275, 772277, 772278, 772280, 772281, 772283, 772284, 772285, 774527, 774530, 774531, 774534, 774535, 774536, 780857, 780858, 780859, 780860, 780861, 780862, 780863, 780867, 780870, 781762, 781763, 781765, 781767, 781768, 781769, 795983, 795984, 795987, 795988, 795989, 795990, 795991, 795994, 795996, 795998, 795999, 796001, 796002, 796003, 796005, 796006, 796007, 796008, 796009, 796011, 796012, 796013, 796014, 796015, 796016, 796017, 796019, 796020, 848240, 848242, 848243, 848244, 848245, 848246, 848248, 848252, 848254, 848256, 848258, 848260, 848526, 848527, 848529, 848530, 848534, 848536, 848537, 848538, 848539, 848541, 848542, 848543, 848545, 848546, 848547, 848549, 848550, 848551, 848554, 848555, 848556, 848558, 848560, 848562, 848563, 848565, 848566, 848567, 848568, 848569, 848570, 848571, 848572, 848573, 848575, 848576, 848577, 1061548, 1061549, 1061550, 1061551, 1061552, 1061553, 1061554, 1061555, 1061556, 1061557, 1061558, 1061559, 1061561, 1061562, 1061567, 1061568, 1061569, 1061570, 1061571, 1061572, 1061573, 1061574, 1061575, 1061576, 1061577, 1061578, 1061579, 1061580, 1160004, 1160005, 1160006, 1160007, 1160008, 1160009, 1160010, 1160011, 1160012, 1160013, 1160014, 1160015, 1160016, 1160017, 1160018, 1160019, 1160020, 1160021, 1160022, 1160023, 1160024, 1160025, 1160026, 1160027, 1160028, 1160029, 1160030, 1160031, 1160032, 1160033, 1160034, 1160035, 1160036, 1202519, 1202520, 1202521, 1202522, 1202523, 1202524, 1202525, 1202526, 1202527, 1202528, 1202529, 1202530, 1202531, 1202532, 1202533, 1202534, 1202535, 1202536, 1202537, 1202538, 1202539, 1202540, 1202541, 1202542, 1202543, 1202544, 1202545, 1202546, 1202547, 1202548, 1202549, 1202550, 1202551, 1202552, 1202553, 1202554, 1202555, 1202556, 1377964, 1377965, 1377966, 1377967, 1377968, 1377969, 1377970, 1377971, 1377972, 1377973, 1380135, 1380136, 1380137, 1380138, 1380139, 1431888, 1431889, 1431890, 1431891, 1431892, 1431893, 1431894, 1431895, 1431896, 1431897, 1433056, 1433057, 1433058, 1433059, 1433060, 1433061, 1433062, 1458382, 1458383, 1458384, 1458385, 1458386, 1458387, 1458388, 1458389, 1458390, 1458391, 1458392, 1458393, 1458394, 1458395, 1458396, 1458847, 1458848, 1458849, 1458850, 1458851, 1458852, 1458853, 1489124, 1489125, 1489126, 1489128, 1489129, 1489130, 1489131, 1489132, 1489133, 1489134, 1489135, 1489136, 1489137, 1489138, 1489140, 1489141, 1489142, 1489143, 1489144, 1489145, 1489146, 1489147, 1489148, 1489149, 1489150, 1502678, 1502679, 1502683, 1502684, 1502685, 1502686, 1502687, 1502688, 1502689, 1502690, 1502693, 1502694, 1502695, 1502696, 1502698, 1502699, 1502700, 1502701, 1527446, 1527447, 1527448, 1527449, 1527450, 1527452, 1527453, 1527454, 1527455, 1527456, 1527457, 1527458, 1527459, 1527460, 1527461, 1527462, 1527463, 1527464, 1527465, 1527466, 1527468, 1527469, 1527470, 1586106, 1586108, 1586109, 1586110, 1586111, 1586112, 1586113, 1586114, 1586115, 1586116, 1586117, 1586118, 1586119, 1586120, 1586121, 1586122, 1586123, 1586125, 1586127, 1586128, 1586129, 1586130, 1586131, 1586133, 1586134, 1586135, 1586136, 1586137, 1586138, 1586139, 1586140, 1586141, 1586142, 1586143, 1586144, 1586145, 1586146, 1587461, 1587462, 1587...

Label field

Details supplied by the agency

Lot, code or applicability

a. REF 130-28-25, GUDID 10885862021984, Serial Numbers: 802593, 802599, 803717, 803737, 841318, 841321, 1572107, 1579369, 1580046, 1583363, 1613871, 1613872, 1613873, 1618998, 1638490, 1638492, 1638494, 1990100, 2282432, 2282433, 2282434; b. REF 130-28-26, GUDID 10885862021991, Serial Numbers: 801865, 801867, 801870, 801872, 801882, 801883, 801886, 801902, 803686, 803690, 803691, 803694, 803695, 803701, 848210, 848213, 848217, 848221, 848222, 848223, 848226, 848232, 848233, 848236, 1677105, 1677106, 1677108, 1677109, 1677110, 1677112, 1677113, 1677114, 1677115, 1677116, 1677118, 1677119, 1677121, 1677122, 1677123, 1677124, 1677126, 1677127, 1677128, 1677129, 1677130, 1677131, 2515330, 2787553, 3871934, 3871935, 3871943; c. REF 130-28-27, GUDID 10885862022004, Serial Numbers: 801542, 801544, 801546, 801547, 801554, 801571, 801572, 801578, 801580, 804033, 804034, 804035, 804036, 862139, 862144, 862146, 1681578, 1681579, 1681580, 1681581, 1681583, 1703643, 1727491, 1727492, 1727493, 1727495, 1727496, 1727497, 1727498, 1727499, 1727500, 1727501, 1727502, 1727503, 1727504, 1727505, 1727506, 1727507, 1727508; d. REF 130-28-28, GUDID 10885862022011, Serial Numbers: 801765; e. REF 130-28-29, GUDID 10885862022028, Serial Numbers: 801654; f. REF 130-32-27, GUDID 10885862022097, Serial Numbers: 966203, 966204, 966205, 966207, 966208, 966209, 966210, 966211, 966212, 966213, 966215, 966216, 966217, 966218, 966219, 966220, 966221, 966222, 966223, 966224, 966225, 966226, 966227, 966228, 966229, 966230, 966231, 966232, 966233, 1042377, 1042378, 1042379, 1042381, 1042382, 1042383, 1042384, 1042385, 1042387, 1042388, 1042391, 1042392, 1042394, 1042395, 1042396, 1042397, 1042398, 1042399, 1042400, 1042401, 1042402, 1042405, 1042406, 1042407, 1042408, 1095431, 1095432, 1095433, 1095434, 1095435, 1095436, 1095437, 1095438, 1095439, 1095440, 1095441, 1095443, 1095444, 1095445, 1095446, 1095447, 1095448, 1095449, 1095537, 1095538, 1095539, 1095541, 1095542, 1095545, 1095546, 1095547, 1095548, 1095550, 1308088, 1308090, 1308092, 1308093, 1308094, 1308095, 1308096, 1308098, 1308102, 1308103, 1308104, 1308105, 1308106, 1308109, 1308111, 1308113, 1308115, 1308116, 1308117, 1308118, 1308119, 1308120, 1984610, 1984611, 1984612, 1984613, 1984614, 1984616, 2053081, 2075035, 2075037, 2075038, 2075039, 2075040, 2075041, 2075042, 2075043, 2075044, 2075045, 2075046, 2075048, 2075049, 2075050, 2075051, 2398494, 2398496, 2398499, 2517474, 2517476, 2517478, 3818434, 3818437, 3818439, 3818444, 3818447; g. REF 130-32-28, GUDID 10885862022103, Serial Numbers: 966299, 966302, 966305, 966307, 966308, 966312, 966313, 966316, 966317, 966318, 966321, 966322, 966327, 1090743, 1090745; f. REF 130-32-29, GUDID 10885862022110, Serial Numbers: 969025, 969026, 969031, 969043; g. REF 130-36-28, GUDID 10885862022202, Serial Numbers: 967669, 967670, 967671, 967672, 967673, 967674, 967675, 967676, 967677, 967678, 967680, 967681, 967683, 967684, 967685, 967686, 967687, 967688, 967689, 967690, 967691, 967692, 967693, 967694, 967695, 967698, 967699, 967700, 967701, 1051661, 1051662, 1051663, 1051664, 1051665, 1051666, 1051667, 1051669, 1051670, 1085957, 1085959, 1085960, 1085961, 1085962, 1085963, 1085964, 1085965, 1085966, 1116002, 1116003, 1116005, 1116006, 1116007, 1116008, 1116009, 1116010, 1116011, 1116012, 1160079, 1160080, 1160081, 1160082, 1160083, 1160084, 1160085, 1160086, 1160087, 1160089, 1206218, 1206219, 1206223, 1206224, 1206225, 1206226, 1668596, 1668597, 1668598, 1668599, 1668600, 1668601, 1668602, 1668603, 1668604, 1668605, 2112376, 2112377, 2112381, 2112382, 2112383, 2112384, 2140027, 2140028, 2504302, 2537040, 2710341, 3871865, 4984351; h. REF 130-36-29, GUDID 10885862022219, Serial Numbers: 975034, 975035, 975036, 975037, 975038, 975040, 975041, 975042, 975043, 975044, 975046, 975047, 975048, 975049, 975050, 975053, 975054, 975055, 975057, 975059, 975063, 1111355, 1111357, 1111358, 1111359, 1111361, 1121576, 1121578, 1121584, 1300472, 1300476, 1300477, 1984741, 1984743, 1984744, 3877076, 3877077, 3877094; i. REF 130-36-30, GUDID 10885862022226, Serial Numbers: 1880259, 1880260, 1880261, 1880262, 1880263, 1880264, 1880265, 1880266, 1880267, 1880268; j. REF 138-28-25, GUDID 10885862024589, Serial Numbers: 805443, 805445, 830281, 830311, 1093756, 1093757, 1632712, 1632713, 1632714, 1632715, 1632716, 1632717, 1662735, 1662736, 1662737, 1667712, 1667715, 1667716, 1667717, 1667718, 1667723, 1667725, 1667726, 1667727, 1667728, 3873889; k. REF 138-28-26, GUDID 10885862024596, Serial Numbers: 805410, 805413, 805421, 805431, 830169, 830177, 830179, 830183, 830184, 830203, 830207, 830209, 830214, 1063813, 1063818, 1063821, 1063830, 1063831, 1737026, 1737027, 1737028, 1737029, 1737030, 1737031, 1737032, 1737033, 2042361, 2042363, 2042364, 2042366, 2042369, 2042372, 2042373, 3840141; l. REF 138-28-27, GUDID 10885862024602, Serial Numbers: 805797, 805799, 805802, 805805, 805806, 805807, 805809, 805810, 805811, 805812, 805816, 805818, 805819, 805820, 805821, 825944, 825949, 825951, 825956, 825961, 825967, 825969, 825970, 825973, 825977, 825978, 825982, 825987, 1063928, 1063941, 2077678, 2077685, 2089964, 3641016, 3873936, 3949986, 3949987; m. REF 138-28-28, GUDID 10885862024619, Serial Numbers: 805355, 805363, 805370, 826263, 826270, 826272, 826275, 1063978; n. REF 138-28-29, GUDID 10885862024626, Serial Numbers: 805827, 805831, 826312, 1063872, 1063889; o. REF 138-36-28, GUDID 10885862024824, Serial Numbers: 807111, 807112, 807113, 807114, 807116, 807119, 807120, 807121, 807122, 807123, 807124, 807125, 807126, 807127, 807128, 807129, 832731, 832732, 832733, 832734, 832735, 832736, 832737, 832738, 832739, 832740, 832742, 832745, 832747, 832748, 832750, 832752, 832754, 832756, 832757, 832758, 832759, 832761, 832763, 832764, 832765, 832767, 832768, 832769, 832770, 832771, 832772, 832773, 832774, 832775, 1019498, 1019499, 1019500, 1019501, 1062910, 1062911, 1062912, 1062913, 1062915, 1062917, 1062918, 1062919, 1062925, 1062927, 1062928, 1223016, 1223017, 1223018, 1223019, 1223022, 1223024, 1223025, 1223026, 1223030, 1223032, 1223033, 1223035, 1223038, 1223039, 1223041, 1900707, 1900708, 1900709, 1900710, 1900711, 1900712, 1920463, 1920464, 1920466, 1920467, 1920468, 1920469, 1920470, 1920471, 1973173, 1973174, 1973175, 1973176, 1973177, 2042392, 2042394, 2313822, 2515477, 2515478, 2800310, 2914514, 2914515, 2914516, 2914517, 2914519, 2914520, 4127080, 4127085, 4127087, 4127089; p. REF 138-36-29, GUDID 10885862024831, Serial Numbers: 807004, 807006, 807013, 807014, 807015, 807017, 807018, 807022, 832683, 832684, 832685, 832686, 832687, 832688, 832690, 832692, 832693, 832694, 832695, 832697, 832698, 832699, 832700, 832706, 832715, 832716, 832717, 832718, 832722, 832723, 832724, 832730, 1086653, 1086658, 1086660, 1086662, 1086665, 1086666, 1086668, 1086672, 1086673, 1636898, 1636900, 1636905, 1636906, 1636908, 1636912, 2102752, 2102757, 2102768, 4127096; q. REF 138-36-30, GUDID 10885862024848, Serial Numbers: 1601226, 1619050, 1619053, 1619054, 1619055. 1619056, 1781527; r. REF 138-36-27, GUDID 10885862024817, Serial Numbers: 1803304; s. REF 132-28-24, GUDID 10885862023063, Serial Numbers: 774713, 775770, 780332, 780345, 780350, 780361, 832888, 832889, 832892, 832893, 832895, 832896, 832897, 832898, 832899, 832907, 832910, 832911, 832913, 832916, 832917, 832918, 832919, 832920, 832921, 832927, 832928, 1425136, 1425137, 1425138, 1425139, 1425140, 1425141, 1425142, 1425143, 1425144, 1461022, 1461023, 1461024, 1461025, 1461026, 1461027, 1461028, 1461029, 1461030, 1461031, 1468006, 1468007, 1468008, 1468011, 1468013, 1500600, 1500601, 1500604, 1500605, 1500606, 1500607, 1506186, 1506187, 1506189, 1506191, 1506193, 1506709, 1506711, 1506712, 1506713, 1506715, 1539850, 1539851, 1547645, 1547646, 1547647, 1547650, 1553669, 1553670, 1553671, 1553673, 1583122, 1583123, 1583124, 1606151, 1606152, 1606155, 1606156, 1606162, 1606163, 1606164, 1606165, 1606166, 1606167, 1606169, 1606170, 1606173, 1606174, 1606175, 1726208, 1726209, 1726211, 1726212, 1726213, 1726214, 1726216, 1726217, 1726218, 1726219, 1726220, 1726221, 1726222, 1726224, 1726225, 1726226, 1726227, 1726228, 1726229, 1726230, 1726232, 1726233, 1726234, 1797506, 1797509, 1797510, 1797511, 1797513, 1797515, 1797516, 1797519, 1797520, 1797521, 1797522, 1797523, 1797524, 1797525, 1797527, 1797528, 1857368, 1857369, 1857370, 1945042, 1945043, 1945044, 1945046, 1945047, 1945048, 1945049, 1945052, 1945054, 1945055, 1945056, 1945057, 1945058, 1945059, 1945061, 1945062, 2420338, 2420339, 2420340, 2420341, 2420342, 2420343, 2574499, 2574500, 2574501, 2574502, 2574503, 2574504, 2574505, 2673229, 2673231, 2673233, 2673235, 2673236, 2673237, 2673238, 2673239, 2673240, 2767967, 2767981, 3863516; t. REF 132-28-25, GUDID 10885862023070, Serial Numbers: 772272, 772273, 772274, 772275, 772277, 772278, 772280, 772281, 772283, 772284, 772285, 774527, 774530, 774531, 774534, 774535, 774536, 780857, 780858, 780859, 780860, 780861, 780862, 780863, 780867, 780870, 781762, 781763, 781765, 781767, 781768, 781769, 795983, 795984, 795987, 795988, 795989, 795990, 795991, 795994, 795996, 795998, 795999, 796001, 796002, 796003, 796005, 796006, 796007, 796008, 796009, 796011, 796012, 796013, 796014, 796015, 796016, 796017, 796019, 796020, 848240, 848242, 848243, 848244, 848245, 848246, 848248, 848252, 848254, 848256, 848258, 848260, 848526, 848527, 848529, 848530, 848534, 848536, 848537, 848538, 848539, 848541, 848542, 848543, 848545, 848546, 848547, 848549, 848550, 848551, 848554, 848555, 848556, 848558, 848560, 848562, 848563, 848565, 848566, 848567, 848568, 848569, 848570, 848571, 848572, 848573, 848575, 848576, 848577, 1061548, 1061549, 1061550, 1061551, 1061552, 1061553, 1061554, 1061555, 1061556, 1061557, 1061558, 1061559, 1061561, 1061562, 1061567, 1061568, 1061569, 1061570, 1061571, 1061572, 1061573, 1061574, 1061575, 1061576, 1061577, 1061578, 1061579, 1061580, 1160004, 1160005, 1160006, 1160007, 1160008, 1160009, 1160010, 1160011, 1160012, 1160013, 1160014, 1160015, 1160016, 1160017, 1160018, 1160019, 1160020, 1160021, 1160022, 1160023, 1160024, 1160025, 1160026, 1160027, 1160028, 1160029, 1160030, 1160031, 1160032, 1160033, 1160034, 1160035, 1160036, 1202519, 1202520, 1202521, 1202522, 1202523, 1202524, 1202525, 1202526, 1202527, 1202528, 1202529, 1202530, 1202531, 1202532, 1202533, 1202534, 1202535, 1202536, 1202537, 1202538, 1202539, 1202540, 1202541, 1202542, 1202543, 1202544, 1202545, 1202546, 1202547, 1202548, 1202549, 1202550, 1202551, 1202552, 1202553, 1202554, 1202555, 1202556, 1377964, 1377965, 1377966, 1377967, 1377968, 1377969, 1377970, 1377971, 1377972, 1377973, 1380135, 1380136, 1380137, 1380138, 1380139, 1431888, 1431889, 1431890, 1431891, 1431892, 1431893, 1431894, 1431895, 1431896, 1431897, 1433056, 1433057, 1433058, 1433059, 1433060, 1433061, 1433062, 1458382, 1458383, 1458384, 1458385, 1458386, 1458387, 1458388, 1458389, 1458390, 1458391, 1458392, 1458393, 1458394, 1458395, 1458396, 1458847, 1458848, 1458849, 1458850, 1458851, 1458852, 1458853, 1489124, 1489125, 1489126, 1489128, 1489129, 1489130, 1489131, 1489132, 1489133, 1489134, 1489135, 1489136, 1489137, 1489138, 1489140, 1489141, 1489142, 1489143, 1489144, 1489145, 1489146, 1489147, 1489148, 1489149, 1489150, 1502678, 1502679, 1502683, 1502684, 1502685, 1502686, 1502687, 1502688, 1502689, 1502690, 1502693, 1502694, 1502695, 1502696, 1502698, 1502699, 1502700, 1502701, 1527446, 1527447, 1527448, 1527449, 1527450, 1527452, 1527453, 1527454, 1527455, 1527456, 1527457, 1527458, 1527459, 1527460, 1527461, 1527462, 1527463, 1527464, 1527465, 1527466, 1527468, 1527469, 1527470, 1586106, 1586108, 1586109, 1586110, 1586111, 1586112, 1586113, 1586114, 1586115, 1586116, 1586117, 1586118, 1586119, 1586120, 1586121, 1586122, 1586123, 1586125, 1586127, 1586128, 1586129, 1586130, 1586131, 1586133, 1586134, 1586135, 1586136, 1586137, 1586138, 1586139, 1586140, 1586141, 1586142, 1586143, 1586144, 1586145, 1586146, 1587461, 1587462, 1587...

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

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

Distribution

Worldwide distribution: US (nationwide) and OUS (foreign) countries of: ARGENTINA, BRAZIL, CHILE, CHINA, COLOMBIA, ECUADOR, GREECE, GUATEMALA, INDIA, LEBANON PORTUGAL,PUERTO RICO,SPAIN

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

Dates in the source

Report date: Sep 21, 2022
Recall initiation date: Aug 11, 2022
Center classification date: Sep 9, 2022

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

What the record says

Lot and product identifiers

Distribution

Dates in the source

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