EDAN Diagnostics, Inc.

Country not established FDA establishment FEI 3009499478

Devices: 0
Registrations: FDA
FDA recalls: 1816 ongoing

No devices from this company are in the catalogue yet.

Company details

FDA FEI number: 3009499478
Address: 9918 Via Pasar, San Diego, CA, 92126

FDA recalls18

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

Recalls initiated per year

2017 1
2018 0
2019 0
2020 0
2021 0
2022 0
2023 0
2024 0
2025 16
2026 0

1 initiated before 2017

Showing the 10 most recent of 18 recalls.

2025
- 24 Oct 2025 Z-1140-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission numbers: K102140, K173042
- 24 Oct 2025 Z-1141-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission numbers: K173042, K150901
- 24 Oct 2025 Z-1142-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission number: K131818
- 24 Oct 2025 Z-1143-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission number: K180380
- 24 Oct 2025 Z-1144-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission numbers: K202892, K233038
- 24 Oct 2025 Z-1145-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission numbers: K131971, K202336, K113623
- 24 Oct 2025 Z-1146-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission number: K160981
- 24 Oct 2025 Z-1147-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission number: K152552
- 24 Oct 2025 Z-1148-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission number: K192514
- 24 Oct 2025 Z-1149-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission number: K232962

Show all 18 recalls

2025
- 24 Oct 2025 Z-1150-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission numbers: K120727, K232694
- 24 Oct 2025 Z-1151-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission number: K171178
- 24 Oct 2025 Z-1152-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission number: K101539
- 24 Oct 2025 Z-1153-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission number: K131818
- 24 Oct 2025 Z-1154-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission number: K113653
- 24 Oct 2025 Z-1155-2026 Class II Ongoing As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. Distribution: Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of CA, KY, PR, FL, CT, IL, PA, RI, NC, NY, LA, TX, MI and the country of Mexico.
  Submission number: K161056
2017
- 17 Nov 2017 Z-1256-2020 Class II Terminated Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA. Distribution: U.S. Nationwide distribution in the state of CA. Submission number: K161056
2016
- 23 Jun 2016 Z-2388-2016 Class II Terminated Incorrect CO2 readings with some patient monitors. Distribution: Worldwide Distribution-U.S (nationwide) distribution to the following states; FL, KY, CA; and countries of: Argentina,…
  Full distribution text
  Worldwide Distribution-U.S (nationwide) distribution to the following states; FL, KY, CA; and countries of: Argentina, China, Colombia, , Ethiopia, France, Germany, Guatemala, India, Italy, Lao People's Democratic Republic, Lithuania, Malaysia, Macedonia, Nepal, New Caledonia, Nicaragua, Pakistan, Poland, Portugal, Russia, Saudi Arabia, South Africa, Sudan, Senegal, Sri Lanka, Thailand, Turkey, United Kingdom, and Uruguay.
  Submission numbers: K110922, K113623, K113653, K131971

This is an FDA establishment record without devices in deviCERTS.