Aurora 4 Series — Class II medical device recall Z-2621-2024
Ongoing recall by DKK Dai-Ichi Shomei Co., Ltd., reported 2024-08-21, distributed nationwide. The weld on the light head frame can crack which could lead to problems such as the light head frame sagging,
| Recall number | Z-2621-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DKK Dai-Ichi Shomei Co., Ltd., Itabashi, Japan |
| Recall initiated | 2024-07-09 |
| Classified | 2024-08-14 |
| Reported by FDA | 2024-08-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CA, EG, HK, ID, JO, JP, KR, NL, NZ, PH, SG, TH |
| Quantity | 538 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 10841736100025 |
| Serial numbers | 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 and 475 more |
| Model numbers | AUA7, AUA7-LH/7TV-LH |
Product
Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2621-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.