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Carestream Medical

Country not established FDA establishment FEI 3010396502

Devices
0
Registrations
FDA
FDA recalls
1

No devices from this company are in the catalogue yet.

Company details

FDA FEI number
3010396502
Address
1201 Upsala Rd, Sanford, FL, 32771

FDA recalls1

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

Recalls initiated per year

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

  • 2018

    • 15 May 2018 Z-2887-2018 Class II Terminated Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing. Distribution: Domestic Distribution: AK, AL, AR ,AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS,…
      Full distribution text Domestic Distribution: AK, AL, AR ,AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV. International Distribution: Canada and Morocco.
      Submission number: K113687

This is an FDA establishment record without devices in deviCERTS.