CLASS II ONGOING Device recall · Reported 21 Aug 2024 · FDA Enforcement Report
Aurora Series, Aurora 7 lighthead recalled by DKK Dai-Ichi Shomei Co
DKK Dai-Ichi Shomei Co is recalling Aurora Series, Aurora 7 lighthead, distributed nationwide in the US. The recall was initiated on 9 Jul 2024 and the FDA has classified it as Class II.
Check your package
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-2618-2024
- FDA event ID
- 94979
- Recalling firm
- DKK Dai-Ichi Shomei Co, Itabashi
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Jul 2024
- FDA classified
- 14 Aug 2024
- Reported
- 21 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Surgical Instruments
Timeline
| 9 Jul 2024 | Recall initiated by company | |
| 14 Aug 2024 | Classified by FDA | +36 days |
| 21 Aug 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
Where it was distributed
Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.
Questions about this recall
Is Aurora Series, Aurora 7 lighthead recalled?
Yes. DKK Dai-Ichi Shomei Co recalled Aurora Series, Aurora 7 lighthead on 9 Jul 2024. The recall is Class II and its status is Ongoing. Recall number Z-2618-2024.
Why was it recalled?
The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching.
Which lots are affected?
Model Number: LED7-LH/7TV-LH; Serial Numbers: 7010002, 7010003, 7010004, 7010005, 7010006, 7030007, 7030008, 7030009, 7030010, 7030011, 7030012, 7030013, 7030014, 7030015, 7030016, 7030017, 7030018, 7030019, 7030020, 7030021, 7040022, 7040023, 7040024, 7040025, 7040026, 7040027, 7040028, 7040029, 7040030, 7040031, 7040032, 7040033, 7040034, 7040035, 7040036, 7040037, 7070039, 7070040, 7070041, 7070042, 7070043, 7070044, 7070045, 7070046, 7070047, 7070048, 7070049, 7070050, 7080053, 7080054, 7080055, 7080056, 7080057, 7080058, 7080059, 7080060, 07080061, 7080062, 7080063, 7080064, 7080065, 7080066, 7080067, 7080068, 7080069, 7080070, 7080071, 7080072, 7080073, 7080074, 7080075, 7080076, 7080077, 7080078, 7080079, 7080080, 7080081, 7090082, 7090083, 7090084, 7090085, 7090086, 7090087, 7090088, 7090089, 7090090, 7090091, 7100092, 7100093, 7100094, 7100095, 7100096, 7100097, 07100098, 7100099, 7100100, 7100101, 7100102, 7100103, 7100104, 7100105, 7100106, 7100107, 7100108, 7100109, 7100110, 7100111, 7110112, 7110113, 7110114, 7110115, 7110116, 7110117, 7110118, 7110119, 7110120, 7110121, 7110122, 7110123, 7110124, 7110125, 7110126, 7110127, 7110128, 7110129, 7110130, 7110131, 7120132, 8010134, 8010135, 8010136, 8010137, 8010138, 8010139, 8010140, 8010141, 8010142, 8010143, 8010144, 8010145, 8010146, 8010147, 8010148, 8010149, 8010150, 8010151, 8010152, 8020153, 8020154, 8020155, 8020156, 8020157, 8020158, 8020159, 8020160, 8020161, 8020162, 8020163, 8020164, 8020165, 8020166, 8020167, 8020168, 8020169, 08020170, 08020171, 08020172, 8020173, 8020174, 8020175, 8020176, 8020177, 8020178, 8020179, 8020180, 8020181, 8020182, 8020183, 8020184, 8020185, 8020186, 8020187, 8020188, 8020189, 8020190, 8020191, 8020192, 8020193, 08020194, 8030195, 8030196, 8030197, 8030198, 8030199, 8030200, 8030201, 8030202, 8030203, 8030204, 8030205, 8030206, 8030207, 8030208, 8030209, 8030210, 8030211, 8030212, 8030213, 8030214, 8030215, 8030216, 8030217, 8030218, 8030219, 8030220, 8030221, 8030222, 8030223, 8030224, 8040225, 8040226, 8040227, 8040228, 8040229, 8040230, 8040231, 8040232, 8040233, 8040234, 8040235, 8040236, 8040237, 8040238, 8040239, 8040240, 8040241, 8040242, 8040243, 8040244, 8040245, 8040246, 8040247, 8050248, 8050249, 8050250, 8050251, 8050252, 8050253, 8050254, 8050255, 8050256, 8050257, 8050258, 8050259, 8050260, 8050261, 8050262, 8050263, 8050264, 8050290, 8050291, 8050292, 8050293, 8050294, 8050295, 8050296, 8050297, 8050298, 8050299, 8050300, 8070301, 8070302, 8070303, 8070304, 8070305, 8070306, 8070307, 8070308, 8070309, 8070310, 8070311, 8070312, 8070313, 8070314, 8070315, 8070316, 8070317, 8070318, 8070319, 8070320, 8080321, 8080322, 8080323, 8080324, 8080325, 8080326, 8080327, 8080328, 8080329, 8080330, 8080331, 8080332, 8080333, 8080334, 8080335, 8080336, 8080337, 8080338, 8080339, 8080340, 8080341, 8080342, 8080343, 8080344, 8080345, 8080346, 8080347, 8080348, 8080349, 8080350, 8090351, 8090352, 8090353, 8090354, 8090355, 8090356, 8090357, 8090358, 8090359, 8090360, 8090361, 8090362, 8090363, 8090364, 8090365, 8100366, 8100367, 8100368, 8100369, 8100370, 8100371, 8100372, 8100373, 8100374, 8100375, 8100376, 8100377, 8100378, 8100379, 8100380, 8100381, 8100382, 8100383, 8100384, 8100385, 8100386, 8100387, 8100388, 8100389, 8100390, 8100391, 8100392, 8100393, 8100394, 8100395, 8100396, 8100397, 8100398, 8110400, 8110401, 8110402, 8110403, 8110404, 8110405, 8110406, 8110407, 8110408, 8120409, 8120410, 8120411, 8120412, 8120413, 8120414, 8120415, 8120416, 8120417, 8120418, 8120419, 8120420, 8120421, 08120422, 8120423, 8120424, 8120425, 8120426, 8120427, 8120428, 8120429, 8120430, 9010431, 9010432, 9010433, 9010434, 9010435, 9010436, 9010437, 9010438, 9010439, 9010440, 9010441, 9010442, 9010443, 9010444, 9010445, 9010446, 9010447, 9010448, 9010449, 9010450, 9020452, 9020453, 9020454, 9020455, 9020456, 9020457, 9020458, 9020459, 9020460, 9020461, 9020462, 9020463, 9020464, 9020465, 9020466, 9020467, 9020468, 9020469, 9020470, 9020471, 9020472, 9020473, 9020474, 9020475, 9020476, 9020477, 9030478, 9030479, 9030480, 9030481, 9030482, 9030483, 9030484, 9030486, 9030487, 9030488, 9030489, 9030490, 9030491, 9030492, 9030493, 9030494, 9030495, 9030496, 9030497, 9030498, 9030499, 9030500, 9030501, 9030502, 9030503, 9030504, 9030505, 9040506, 9040507, 9060509, 9060510, 9060511, 9060512, 9060513, 9060514, 9060515, 9060516, 9070517, 9070518, 9070519, 9070520, 9070521, 9080531, 9080532, 9080533, 9080534, 9080535, 9080536, 9080537, 9080538, 9080539, 9080540, 9080541, 9120543, 9120544, 10010545, 10010546, 10010547, 10010548, 10010549, 10020055, 10020551, 10020552, 10020553, 10020554, 10020555, 10020556, 10020557, 10030558, 10030559, 10030560, 10030561, 10030562, 10030563, 10030564, 10030565, 10030566, 10030567, 10040568, 10040569, 10040570, 10040571, 10040572, 10040573, 10050574, 10050575, 10050576, 10050577, 10050578, 10050579, 10080580, 10080581, 10080582, 10080583, 10080584, 10090585, 10090586, 10090587, 10090588, 10090589, 10090590, 10090591, 12070597, 12070598, 12080599, 12080600, 12080601, 12080602, 12080603, 12080604,
Where was it sold?
Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from DKK Dai-Ichi Shomei Co
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Aurora 2 Series, Aurora 7 lighthead recalled by DKK Dai-Ichi Shomei Co | DKK Dai-Ichi Shomei Co | Foreign Material | Nationwide |
| Device | CLASS II | Aurora 3 Series, Aurora 7 lighthead recalled by DKK Dai-Ichi Shomei Co | DKK Dai-Ichi Shomei Co | Foreign Material | Nationwide |
| Device | CLASS II | Aurora 4 Series, Aurora 7 lighthead recalled by DKK Dai-Ichi Shomei Co | DKK Dai-Ichi Shomei Co | Foreign Material | Nationwide |
| Device | CLASS II | LFS Flat screen arm system with surgical lamp recalled | DKK Dai-Ichi Shomei Co | Device Malfunction | MI |
| Device | CLASS II | LFS Flat screen support arm systems without surgical lamp recalled | DKK Dai-Ichi Shomei Co | Device Malfunction | MI |
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