Z-3224-2026 Class II Ongoing
FDA device recall Z-3224-2026 was initiated by Maquet SAS on Aug 7, 2026 and is designated Class II. Reason for recall: The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury. The recall status is ongoing. Affected quantity: 667.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 30, 2026
- Initiation Date
- Aug 7, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 667
Product Description
PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;
Reason for Recall
The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
Distribution Pattern
US Nationwide distribution.
Code Information
1. Model Number: ARD568474114A; UDI-DI: N/A; Serial Numbers: 500190, 500194, 500201, 500203, 500209, 500216, 500218, 500197, 500204, 500210, 500211, 500212, 500213, 500214, 500217, 500206, 500390, 500393, 500397, 500414, 500416, 500417, 500418, 500451, 500266, 500284, 500291, 500293, 500294, 500299, 500300, 500301, 500302, 500306, 500307, 500308, 500117, 500116, 500273, 500274, 500399, 500400, 500402, 500168, 500188, 500192, 500196, 500208, 500219, 500221, 500228, 500233, 500237, 500240, 500247, 500159, 500207, 500215, 500396, 500415, 500419, 500429, 500430, 500433, 500434, 500437, 500439, 500440, 500443, 500478, 500394, 500398, 500403, 500407, 500391, 500404, 500060, 500061, 500062, 500063, 500080, 500081, 500086, 500089, 500094, 500095, 500096, 500099, 500105, 500106, 500111, 500112, 500118, 500119, 500392, 500395, 500405, 500406, 500409, 500427, 500428, 500435, 500436, 500238, 500249, 500251, 500254, 500256, 500258, 500259, 500260, 500261, 500262, 500277, 500278, 500285, 500296, 500304, 500309, 500311, 500312, 500316, 500323, 500328, 500331, 500332, 500338, 500198, 500200, 500067, 500073, 500074, 500076, 500079, 500082, 500069, 500161, 500078, 500051, 500053, 500093, 500100, 500107, 500108, 500113, 500114, 500065, 500070, 500071, 500072, 500075, 500077, 500084, 500085, 500087, 500143, 500145, 500152, 500164, 500167, 500178, 500179, 500253, 500255, 500267, 500268, 500286, 500287, 500292, 500224, 500225, 500229, 500235, 500236, 500128, 500134, 500137, 500148, 500149, 500129, 500173, 500177, 500182, 500184, 500185, 500189, 500195, 500199, 500205, 500169, 500170, 500180, 500142, 500144, 500166, 500172, 500174, 500175, 500181, 500242, 500160, 500162, 500165, 500176, 500157, 500158, 500163, 500171, 500068, 500088, 500131, 500132, 500133, 500151, 500220, 500223, 500226, 500241, 500245, 500248, 500064, 500313, 500315, 500317, 500318, 500320, 500324, 500325, 500326, 500327, 500329, 500330, 500333, 500334, 500335, 500337, 500092, 500097, 500098, 500101, 500102, 500103, 500104, 500109, 500110, 500115, 500120, 500121, 500408, 500359, 500361, 500362, 500363, 500364, 500365, 500368, 500369, 500370, 500372, 500380, 500232, 500239, 500263, 500264, 500269, 500271, 500272, 500373, 500374, 500375, 500386, 500387, 500453, 500454, 500455, 500456, 500461, 500462, 500492, 500493, 500279, 500303, 500305, 500413, 500422, 500425, 500426, 500431, 500438, 500444, 500445, 500446, 500130, 500135, 500136, 500138, 500141, 500146, 500150, 500153, 500154, 500280, 500281, 500282, 500297, 500028, 500029, 500031, 500032, 500033, 500036, 500040, 500041, 500042, 500049, 500056, 500183, 500193, 500257, 500270, 500275, 500276, 500401, 500410, 500411, 500412, 500423, 500424, 500441, 500442, 500447, 500448, 500420, 500421, 500432, 500243, 500037, 500083, 500125, 500126, 500127, 500139, 500140, 500147, 500250, 500252, 500265, 500283, 500288, 500289, 500290, 500295, 500298, 500030, 500034, 500035, 500038, 500039, 500043, 500044, 500045, 500046, 500047, 500048, 500050, 500052, 500054, 500055, 500057, 500227, 500230, 500234, 500244, 500246, 500066, 500222, 500231, 500314, 500319, 500321, 500322, 500336, 500360, 500366, 500367, 500371, 500376, 500377, 500378, 500379, 500381, 500382, 500383, 500384, 500385, 500388, 500186; 2. Model Number: ARD567501286; UDI-DI: 03700712403478; Serial Numbers: 1314H000217400, 4014H000279430, 4014H000279432, 4014H000279433, 4014H000279434, 4014H000279437, 4014H000279438, 4314H000288228, 4314H000288229, 4314H000288232, 4314H000288233, 4314H000288234, 4314H000288237, 4314H000288239, 4314H000288257, 4314H000288258, 4314H000288259, 4714H000296081, 4717H000296095, 1315H000382641, 1715H000392775, 2115H000409030, 2115H000409038, 2115H000409040, 2115H000409062, 2113H000123425, 3613H000150570, 2115H000409063, 3015H000436557, 3015H000436569, 3015H000436571, 2115H000409065, 2115H000409067, 2615H000423256, 3015H000436561, 3015H000436566, 3015H000436570, 1314H000215902, 1314H000215904, 0116H000537022, 0716H000208366, 2816H000647716, 0615H000334882, 0615H000334887, 0615H000334891, 0815H000351763, 0815H000351768, 0815H000351780, 1314H000215893, 1314H000215894, 1314H000215896, 1314H000215900, 1314H000215903, 1314H000215907, 1314H000215885, 2114H000236788, 2613H000132823, 2613H000132825, 2613H000132826, 2613H000132827, 2613H000132828, 2614H000244892, 3613H000150571, 3613H000150572, 4014H000279429, 4014H000279431, 4314H000288230, 4314H000288235, 1314H000215886, 1314H000215895, 1314H000215898, 1314H000215899, 1314H000215908, 2114H000236778, 2114H000236779, 2114H000236787, 2114H000236789, 2114H000236790, 2614H000244886, 2115H000409051, 2115H000409058, 3015H000436556, 3015H000436558, 3015H000436568, 4314H000288231, 1314H000215888, 1314H000215889, 1314H000215906, 1314H000215879, 1314H000215880, 1314H000215881, 1314H000215882, 1314H000215890, 1314H000215892, 1314H000215897, 1314H000215901, 2614H000244885, 2113H000123420, 2113H000123421, 2113H000123423, 2113H000123424, 2113H000123426, 2113H000123427, 2113H000123429, 2613H000132824, 2816H000647710, 2614H000244884, 2614H000244889, 2114H000236777, 2114H000236782, 2114H000236785, 2614H000244877, 2614H000244878, 2614H000244883, 2614H000244890, 1314H000215905, 2115H000409039, 0116H000537017, 0116H000537020, 0116H000537021, 0116H000537023, 0116H000537024, 0116H000537025, 0116H000537026, 0615H000334878, 0615H000334881, 0715H000391839, 0716H000261478, 0716H000561475, 0716H000561479, 0716H000561493, 1314H000217399, 2215H000537018, 2615H000423253, 2816H000647709, 2816H000647712, 2816H000647714, 2916H000647713, 3015H000436560, 3015H000436564, 4314H000288260, 4714H000296097, 1314H000215883, 1314H000215884, 1314H000215887, 0815H000351782, 2115H000409029, 2114H000236780, 2114H000236781, 2114H000236783, 2114H000236784, 2114H000236786, 2614H000244879, 2614H000244880, 2614H000244887, 2614H000244888, 2614H000244891, 2115H000409027, 2115H000409055, 2115H000409032, 2115H000409034, 2115H000409053, 2115H000409064, 2115H000409070, 2615H000423252, 2615H000423254, 3015H000436563, 0116H000537019, 0716H000561481, 3613H000150569, 0615H000334888, 0615H000334889, 0716H000561477, 0716H000561480, 0615H000334883, 0615H000334884, 2115H000409068, 2115H000409069, 2615H000423258, 3015H000436559, 3015H000436562, 3015H000436565, 3015H000436567, 4314H000288236, 4314H000288240, 0615H000334885, 0615H000334886, 0615H000334890, 0815H000351765, 0815H000351767, 0815H000351771, 0815H000351776, 0815H000351777, 0815H000351779, 1314H000215891, 2614H000244881, 2614H000244882, 4014H000279436, 4314H000288238, 4314H000288261, 1813H000118088, 1813H000118093, 2613H000132815, 2613H000132818, 3613H000150533, 3613H000150534, 3613H000150537, 3613H000150538, 3613H000150541, 2613H000132811, 3613H000150544, 3613H000150545, 3613H000150546, 3613H000150547, 3613H000150548, 3613H000150565, 3613H000150566, 3613H000150567, 3613H000150568, 0815H000351774, 4014H000279428, 2115H000409054, 0815H000351773, 1315H000382643, 1315H000382644, 2115H000409028, 2115H000409033, 2115H000409035, 2115H000409036, 2115H000409037, 2115H000409052, 2115H000409056, 2115H000409057, 2115H000409059, 2115H000409060, 2115H000409061, 2816H000647715, 0815H000351775, 0815H000351778, 4014H000279435, 3613H000150535, 3613H000150536, 3613H000150539, 3613H000150540, 3613H000150542, 3613H000150543, 2115H000409031, 0815H000351764, 0815H000351766, 0815H000351769, 0815H000351770, 0815H000351772, 0815H000351781, 1813H000118090, 2113H0001231, 2113H000123428, 2613H000132800, 2613H000132801, 2613H000132802, 2613H000132803, 2613H000132804, 2613H000132806, 2613H000132807, 2613H000132808, 2613H000132809, 2613H000132810, 2613H000132812, 2613H000132813, 2613H000132814, 2813H000132805;