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Nova Ortho-Med, Inc.

United Statesfrom the FDA registration address FDA establishment FEI 3002329391

Devices
1
Registrations
FDA
FDA recalls
53 ongoing since 2021 (4 open in total)
1 open since before 2021

Catalogue1

Newest first, rows 1-1 of 1

Company details

FDA FEI number
3002329391
Address
410 Smoketree Plaza Suite 100, North Aurora, IL, 60542

FDA recalls5

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 1
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 3
  • 2025 0
  • 2026 0

1 initiated before 2017

  • 2024

    • 26 Aug 2024 Z-0129-2025 Class II Ongoing Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL AZ, CA, CO, CT, FL, GA, Guam, HI, IA, ID, IL,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AL AZ, CA, CO, CT, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI and WY. The country of Canada.
    • 26 Aug 2024 Z-0130-2025 Class II Ongoing Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL AZ, CA, CO, CT, FL, GA, Guam, HI, IA, ID, IL,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AL AZ, CA, CO, CT, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI and WY. The country of Canada.
    • 26 Aug 2024 Z-0131-2025 Class II Ongoing Firm identified a potential risk for a fall hazard. When the end user is readjusting from the slouched seated position to an upright seated position, there is the potential for the movement to cause the backrest to lift out of the backrest holder and disengage from the unit. Distribution: Worldwide - U.S. Nationwide distribution including in the states of AK, AL AZ, CA, CO, CT, FL, GA, Guam, HI, IA, ID, IL,…
      Full distribution text Worldwide - U.S. Nationwide distribution including in the states of AK, AL AZ, CA, CO, CT, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, WA, WI and WY. The country of Canada.

  • 2019

    • 7 Oct 2019 Z-0654-2021 Class II Open since 2019 Walkers within the identified serial range have the potential for the front fork to unscrew itself from the leg. A partially unscrewed fork creates unevenness in the wheelbase, which could cause instability, that if not detected by the user, may result in the front fork falling off the walker. Distribution: U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, OH, OK,…
      Full distribution text U.S.: AK, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NM, NV, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI, WY O.U.S.: Taiwan

  • 2016

    • 1 Oct 2016 Z-0304-2017 Class II Terminated Nova Medical is recalling the Journey Rolling Walker because the screws used to hold the black side support pieces to the frame can become loose over time. This can result in the locking nut coming off and the screw falling out. Distribution: US Nationwide Distribution in the states of: CA, IN, HI, CT, UT, WA, FL, VA, WI, OH, MN, KS, MD, IL, MO, WY, MT, ME, PA,…
      Full distribution text US Nationwide Distribution in the states of: CA, IN, HI, CT, UT, WA, FL, VA, WI, OH, MN, KS, MD, IL, MO, WY, MT, ME, PA, TN, MI, OR, NY, NJ, ID, NC, IA, OK, AR, VT, SC, TX

Frequently asked questions

How many devices does NOVA ORTHO-MED, INC. have in the registry?

The registry currently lists 1 device for NOVA ORTHO-MED, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list NOVA ORTHO-MED, INC.'s devices?

Among its 1 most recently registered device, NOVA ORTHO-MED, INC. has devices listed in FDA 510(k) (1 device).

What risk classes do NOVA ORTHO-MED, INC.'s devices fall under?

Among its 1 most recently registered device, the classes recorded for NOVA ORTHO-MED, INC.'s devices are Class I. Each device page shows its own class and authorisation.

Are there FDA recall records for NOVA ORTHO-MED, INC.?

FDA recall records list 5 recalls initiated by NOVA ORTHO-MED, INC., the most recent initiated on 26 Aug 2024. 4 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from NOVA ORTHO-MED, INC. in the registry?

The most recently registered devices listed for NOVA ORTHO-MED, INC. include 7000 SERIES LIGHTWEIGHT WHEELCHAIR, MODELS 7160L, 7180L AND 7200L.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.