Dkk Dai-Ichi Shomei Co, Ltd

Country not established FDA establishment FEI 3006437518

Devices: 0
Registrations: FDA
FDA recalls: 66 ongoing

No devices from this company are in the catalogue yet.

Company details

FDA FEI number: 3006437518
Address: 1-32-26, SAKASHITA, ITABASHI-KU Tokyo

FDA recalls6

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

2017 0
2018 0
2019 0
2020 0
2021 0
2022 0
2023 2
2024 4
2025 0
2026 0

2024
- 9 Jul 2024 Z-2618-2024 Class II Ongoing 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. Distribution: Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan,…
  Full distribution text
  Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.
  Submission number: K071698
- 9 Jul 2024 Z-2619-2024 Class II Ongoing 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. Distribution: Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan,…
  Full distribution text
  Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.
  Submission number: K071698
- 9 Jul 2024 Z-2620-2024 Class II Ongoing 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. Distribution: Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan,…
  Full distribution text
  Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.
  Submission number: K071698
- 9 Jul 2024 Z-2621-2024 Class II Ongoing 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. Distribution: Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan,…
  Full distribution text
  Domestic: Nationwide Distribution International: Australia, Canada, Egypt, Hong Kong, Indonesia, Japan, Jordan, Netherlands, New Zealand, Philippines, Singapore, South America, South Korea, Thailand, UAE.
  Submission number: K071698
2023
- 23 Aug 2023 Z-0071-2024 Class II Ongoing The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the flat screen attached to the LFS flat screen system can rotate beyond the original angle limit and it could cause excessive force to be given to the spring shaft of the LFS bracket. Due to the excessive force given to the spring shaft, the spring shaft could break and shear off. Distribution: US States: MI
- 23 Aug 2023 Z-0072-2024 Class II Ongoing The stopper block on the LFS bracket could be broken or missing. Without this stopper block, the flat screen attached to the LFS flat screen system can rotate beyond the original angle limit and it could cause excessive force to be given to the spring shaft of the LFS bracket. Due to the excessive force given to the spring shaft, the spring shaft could break and shear off. Distribution: US States: MI

This is an FDA establishment record without devices in deviCERTS.