DKK Dai-Ichi Shomei Co., Ltd.
FDA Regulatory Profile
DKK Dai-Ichi Shomei Co., Ltd. has 6 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- Z-2621-2024 · Class II · Jul 9, 2024
- Latest inspection
- Jul 20, 2018 · OAI
Reviewing DKK Dai-Ichi Shomei Co., Ltd. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Check this supplier
Or check DKK Dai-Ichi Shomei Co., Ltd. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Get a free API key
Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 6 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 2 | Nov 10, 2026 | Newest record Nov 5, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2621-2024 | Class II | Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is… | Jul 9, 2024 |
| Z-2618-2024 | Class II | Aurora Series, Aurora 7 lighthead; Models: LED7 (including TV models). The Aurora Series is… | Jul 9, 2024 |
| Z-2620-2024 | Class II | Aurora 3 Series, Aurora 7 lighthead; Models: AUT7 (including TV models). The Aurora Series is… | Jul 9, 2024 |
| Z-2619-2024 | Class II | Aurora 2 Series, Aurora 7 lighthead; Models: AUR7 (including TV models). The Aurora Series is… | Jul 9, 2024 |
| Z-0071-2024 | Class II | LFS Flat screen arm system with surgical lamp for Models Aurora series, Aurora 2 series, Aurora 3… | Aug 23, 2023 |
| Z-0072-2024 | Class II | LFS Flat screen support arm systems without surgical lamp for models Aurora series, Aurora 2 series… | Aug 23, 2023 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3006437518 | Itabashi, Japan | 2 | Jul 20, 2018 |