Djo, LLC

United StatesFDA applicant, unverified FDA FEI 3017264244

Devices: 2,605
Registrations: FDA
FDA recalls: 117 ongoing since 2021 (8 open in total); 1 open since before 2021

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA FEI, FDA recalls

What Djo, LLC makes

DJO, LLC manufactures reusable orthopaedic instruments for prosthesis implantation positioning, single-use compression socks and stockings, and custom orthoses for the ankle, foot, and knee. Their portfolio also includes orthopaedic broaches, reusable hot/cold therapy packs, mobile traction systems, and control units for circulating-fluid thermal therapy.

The company’s devices are classified under FDA’s Class I, II, and III categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2,605

Newest first, rows 1-50 of 2,605

Search and filter all 2,605 devices

Rows 1-50 of 2,605

Showing 1-50 of 2,605

Company details

FDA FEI number: 3017264244
DUNS number: 081840873
Address: 5919 Sea Otter Place, Carlsbad, CA, 92010
Email: [email protected]
Phone: 760-734-3161

FDA recalls11

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 11 recalls initiated by DJO, LLC, the earliest on 2013-05-28 and the most recent on 2026-03-19. By recorded status: 8 ongoing and 3 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, electrical or power, mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

2017 0
2018 1
2019 1
2020 0
2021 2
2022 0
2023 0
2024 0
2025 1
2026 4

2 initiated before 2017

Showing the 10 most recent of 11 recalls.

2026
- 19 Mar 2026 Z-2134-2026 Class II Ongoing Due to broken connector which may result in a temporary interruption of prescribed cold therapy. Distribution: Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD,…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.
- 19 Mar 2026 Z-2135-2026 Class II Ongoing Due to broken connector which may result in a temporary interruption of prescribed cold therapy. Distribution: Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD,…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.
- 19 Mar 2026 Z-2136-2026 Class II Ongoing Due to broken connector which may result in a temporary interruption of prescribed cold therapy. Distribution: Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD,…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.
- 19 Mar 2026 Z-2137-2026 Class II Ongoing Due to broken connector which may result in a temporary interruption of prescribed cold therapy. Distribution: Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD,…
  Full distribution text
  Worldwide - U.S. Nationwide distribution in the states of AK, AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, NC, NE. NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. The country of Canada.
2025
- 25 Sep 2025 Z-0722-2026 Class II Ongoing The IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may cause the wrap to leak or break at the seams and/or reach temperatures capable of causing a second degree burn. Distribution: US Nationwide distribution in the states of WI, TN, TX, MD, GA, UT, WA, MI, NC, NE, CA, MA, CO, SC, OH, IN, MN, NM, PA,…
  Full distribution text
  US Nationwide distribution in the states of WI, TN, TX, MD, GA, UT, WA, MI, NC, NE, CA, MA, CO, SC, OH, IN, MN, NM, PA, NY, IL, FL, NJ, VA, AZ, VT, CT, OK.
2021
- 7 Sep 2021 Z-0009-2022 Class I Ongoing Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health. Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of ND, NJ, CO, HI, CA, MA, FL, GA, IN, WA,…
  Full distribution text
  Worldwide distribution - U.S. Nationwide distribution including in the states of ND, NJ, CO, HI, CA, MA, FL, GA, IN, WA, NY, TX, IA, TN, NV, LA, CT, VA, NC, WI, MS, OR, MI, AL, MN, VT, IL, OH, AR, NM, DE, PA, SC, AZ, MD, RI, KY, UT, MO, OK, MT, ID, NE, WY, ME, WV, SD, KS, PR, NH, DC, AK, VI and the countries of France, China, Mexico, Ontario, Australia.
  Submission number: K955246
- 7 Sep 2021 Z-0010-2022 Class I Ongoing Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-letter-health. Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of ND, NJ, CO, HI, CA, MA, FL, GA, IN, WA,…
  Full distribution text
  Worldwide distribution - U.S. Nationwide distribution including in the states of ND, NJ, CO, HI, CA, MA, FL, GA, IN, WA, NY, TX, IA, TN, NV, LA, CT, VA, NC, WI, MS, OR, MI, AL, MN, VT, IL, OH, AR, NM, DE, PA, SC, AZ, MD, RI, KY, UT, MO, OK, MT, ID, NE, WY, ME, WV, SD, KS, PR, NH, DC, AK, VI and the countries of France, China, Mexico, Ontario, Australia.
  Submission number: K962840
2019
- 17 Jan 2019 Z-1985-2019 Class II Open since 2019 The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements. Distribution: Distributed domestically, Oklahoma Submission number: K964238
2018
- 25 Jun 2018 Z-2590-2020 Class II Terminated The device accessories were not labeled with appropriate latex warning. Distribution: Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA,…
  Full distribution text
  Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and WV The countries of Algeria, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Congo, Congo, The Democratic Republic of the, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, England, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea, Republic of, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, T…
2015
- 21 Aug 2015 Z-0121-2016 Class II Terminated Overheating and burning of the wire insulation inside the applicator. Distribution: Worldwide Distribution - US Nationwide in the states of WY, OH, WA, NC, FL, NE, GA, KS CA, MO, IN, MA, IL, OK, AZ, TX,…
  Full distribution text
  Worldwide Distribution - US Nationwide in the states of WY, OH, WA, NC, FL, NE, GA, KS CA, MO, IN, MA, IL, OK, AZ, TX, AR, UT, NJ, WI, PA, SC, WV, NY, MI, MN, VA, AK, TN, OR, NC, NH, KY, CO, NV, ID and the countries of El Salvador, China, Ecuador, South Korea, Chile, Israel, Peru, Nicaragua, Bolivia, Indonesia
  Submission number: K083433

Show all 11 recalls

2013
- 28 May 2013 Z-1661-2013 Class II Terminated DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlow 30B-B and 30 BI-B products. There is a potential for battery leakage which could result in thermal meltdown (fire). Distribution: Worldwide Distribution - USA Nationwide and countries of: Australia, Belgium, China, Guatemala CentroAmeria, France,…
  Full distribution text
  Worldwide Distribution - USA Nationwide and countries of: Australia, Belgium, China, Guatemala CentroAmeria, France, Hong Kong, India,Italy, Korea, Lebanon, Malaysia, Morocco, Pakistan, Paraguay, The Netherlands, Romania, Singapore, Spain, Sweden, Thailand, Turkey, United Arab Emirates, United Kingdom and Venezula.
  Submission number: K091700

Frequently asked questions

How many devices does DJO, LLC have in the registry?

The registry currently lists 2605 devices for DJO, LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list DJO, LLC's devices?

Among its 50 most recently registered devices, DJO, LLC has devices listed in FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do DJO, LLC's devices fall under?

Among its 50 most recently registered devices, the classes recorded for DJO, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for DJO, LLC?

FDA recall records list 11 recalls initiated by DJO, LLC, the most recent initiated on 19 Mar 2026. 8 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 DJO, LLC in the registry?

The most recently registered devices listed for DJO, LLC include PROCARE 155-79-87114, PROCARE 155-79-87117, PROCARE 155-79-87113 and PROCARE 155-79-87050.

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