CLASS II ONGOING Device recall · Reported 30 Sep 2026 · FDA Enforcement Report

PowerLED 300 Concealed Lighting System recalled by Maquet SAS

Maquet SAS is recalling PowerLED 300 Concealed Lighting System (PWD30+SF W K3 Spring ARM A2 FC3 50-100nm), distributed nationwide in the US. The recall was initiated on 7 Aug 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes1. 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;

Quantity recalled667

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3224-2026
FDA event ID: 99696
Recalling firm: Maquet SAS, Orleans Cedex 2
Classification: Class II
Status: Ongoing
Recall initiated: 7 Aug 2026
FDA classified: 18 Sep 2026
Reported: 30 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

7 Aug 2026	Recall initiated by company
18 Sep 2026	Classified by FDA	+42 days
30 Sep 2026	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286;

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.

Which lots are affected?

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;

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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