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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

DKK Dai-Ichi Shomei Co., Ltd.: Aurora Series Surgical Light Heads Recalled for Risk of Detaching

Agency Publication Date: August 14, 2024
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Summary

DKK Dai-Ichi Shomei Co., Ltd. has recalled approximately 2,208 Aurora Series surgical light heads because a weld on the light head frame can crack. This structural failure can cause the light head to sag, the plastic housing to crack, or the light head to detach entirely and fall. These units were distributed nationwide and are used to illuminate surgical fields during medical procedures. Consumers should contact their healthcare provider or the manufacturer to address this safety issue.

Risk

A cracked weld can cause the surgical light head to detach and fall from its mounting, posing a direct impact injury risk to patients and medical staff during a procedure. Additionally, sagging or cracking can interfere with the visibility of the surgical site.

What You Should Do

  1. Identify your equipment by checking the model and serial numbers on the Aurora series light head. Affected models include Aurora Series LED7, Aurora 2 Series AUR7, Aurora 3 Series AUT7, and Aurora 4 Series AUA7.
  2. For Model LED7-LH/7TV-LH (Aurora Series), check for serial numbers including 7010002 through 12080604. There are 555 units affected in this specific series.
  3. For Model AUR7-LH/7TV-LH (Aurora 2 Series), check for serial numbers including 09010002 through 20040831 and prototype 08120001. There are 822 units affected.
  4. For Model AUT7-LH/TV-LH (Aurora 3 Series), check for serial numbers ranging from 13040011 through 14080303. There are 293 units affected.
  5. For Model AUA7-LH/7TV-LH (Aurora 4 Series), check for UDI-DI 10841736100025 and serial numbers ranging from 07120133 through 2023-11-0555. There are 538 units affected.
  6. Contact your healthcare provider, facility manager, or the manufacturer, DKK Dai-Ichi Shomei Co., Ltd., immediately to schedule an inspection or receive further instructions regarding repairs or replacements.
  7. Contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions or need to report an incident.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction/instruction

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Aurora Series, Aurora 7 lighthead; Model LED7
Model / REF:
LED7-LH/7TV-LH
Lot Numbers (555):
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
Product: Aurora 2 Series, Aurora 7 lighthead; Model AUR7
Model / REF:
AUR7-LH/7TV-LH
Lot Numbers (822):
09010002
9020003
9020004
9020007
9020008
9020009
9020010
9020011
9020012
9020013
9020014
9020015
9020016
9030017
9030018
9030019
9030020
9030021
9030022
9040023
9040024
9040025
9040026
9040027
9040028
9040029
9040030
9040031
9040032
9040033
9040034
9040035
9040036
9040037
9040038
9040039
9040040
9040041
9040042
9050043
9050044
9050045
9050046
9050047
9050048
9050049
9050050
9050051
9050052
9050053
Product: Aurora 3 Series, Aurora 7 lighthead; Model AUT7
Model / REF:
AUT7-LH/TV-LH
Lot Numbers (293):
13040011
13040012
13040013
13040014
13040015
13040016
13040017
13040018
13040019
13040020
13040021
13040022
13040023
13040024
13070025
13070026
13070027
13070028
13070029
13070030
13070031
13070032
13070033
13070034
13070035
13070036
13070037
13070038
13070039
13070040
13070041
13070042
13070043
13080044
13080045
13080046
13080047
13080048
13080049
13080050
13080051
13080052
13080053
13090054
13090055
13090056
13090057
13090058
13090059
13090060
Product: Aurora 4 Series, Aurora 7 lighthead; Model AUA7
Model / REF:
AUA7-LH/7TV-LH
Lot Numbers (538):
07120133
2015-03-0001
2015-03-0002
2015-03-0003
2015-03-0004
2015-03-0005
2015-03-0006
2015-03-0007
2015-03-0008
2015-03-0009
2015-03-0010
2015-04-0011
2015-04-0012
2015-04-0013
2015-04-0014
2015-04-0015
2015-04-0016
2015-04-0017
2015-04-0018
2015-04-0019
2015-04-0020
2015-04-0021
2015-04-0022
2015-04-0023
2015-04-0024
2015-04-0025
2015-05-0026
2015-05-0027
2015-05-0028
2015-05-0029
2015-05-0030
2015-05-0031
2015-05-0032
2015-05-0033
2015-05-0034
2015-05-0035
2015-05-0036
2015-05-0037
2015-05-0038
2015-05-0039
2015-05-0040
2015-06-0041
2015-06-0042
2015-06-0043
2015-06-0044
2015-06-0045
2015-06-0046
2015-06-0047
2015-06-0048
2015-06-0049

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94979
Status: Active
Manufacturer: DKK Dai-Ichi Shomei Co., Ltd.
Sold By: medical equipment distributors
Manufactured In: Japan
Units Affected: 4 products (555 units; 822 units; 293 units; 538 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.