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DJO, LLC

US

Last updated September 17, 2026

Information

Country
US
Address
5919 Sea Otter Place, Carlsbad, CA, 92010
Website
djoglobal.com
LinkedIn
—
Facebook
—
Phone
760-734-3161
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
3017264244
DUNS Number
081840873

Catalogue (2587)

Page 40 of 52
DeviceModel / ReferenceRegistriesClassStatus
Lightforce PRD-000758-010-00-L-G5
FDA UDI
Class IIActive
Djo Surgical 803-00-115
FDA UDI
Class IActive
Djo Surgical 804-05-116
FDA UDI
Class IActive
Bell-Horn 118102X
FDA UDI
Class IIActive
Djo Surgical 800-01-164
FDA UDI
Class IActive
Djo Surgical 803-03-061
FDA UDI
Class IActive
Donjoy 11-1636
FDA UDI
Class IIActive
Djo Surgical 804-33-105
FDA UDI
Class IActive
Aircast 1209
FDA UDI
Class IIActive
Djo Surgical 804-25-045
FDA UDI
Class IActive
Aircast 15A
FDA UDI
Class IIActive
Aircast 3007XL
FDA UDI
Class IIActive
Aircast 31M
FDA UDI
Class IIActive
Bell-Horn 113103X-LONG
FDA UDI
Class IIUnknown
Chattanooga 2302-3
FDA UDI
Class IActive
Exos 311-31-1111
FDA UDI
Class IActive
Chattanooga 28501
FDA UDI
Class IIActive
Chattanooga 199723
FDA UDI
Class IIActive
Procare 155-79-87082
FDA UDI
Class IActive
Chattanooga 13-8083
FDA UDI
Class IIActive
Bell-Horn 11310XL-LONG
FDA UDI
Class IIUnknown
Aircast 3012
FDA UDI
Class IIActive
Chattanooga 77598
FDA UDI
Class IIActive
Procare 79-84005-0213
FDA UDI
Class IActive
Chattanooga 2789-10
FDA UDI
Class IIActive
Chattanooga 78048
FDA UDI
Class IIActive
Djo Surgical 804-05-148
FDA UDI
Class IActive
Djo Surgical 801-01-547
FDA UDI
Class IActive
Djo Surgical 803-61-209
FDA UDI
Class IActive
Djo Surgical 803-04-336
FDA UDI
Class IActive
Chattanooga 4767
FDA UDI
Class IIActive
Djo Surgical 233-08-104
FDA UDI
Class IIActive
Procare 79-90180
FDA UDI
Class IActive
Procare 79-91220
FDA UDI
Class IActive
Exos 311-31-4444
FDA UDI
Class IActive
Djo Surgical 803-05-085
FDA UDI
Class IActive
Djo Surgical 803-55-381
FDA UDI
Class IActive
Djo Surgical 802-01-074
FDA UDI
Class IActive
Donjoy Performance DP171KS01-SGR-M
FDA UDI
Class IActive
Chattanooga 42189
FDA UDI
Class IIActive
Bell-Horn 11814M
FDA UDI
Class IActive
Chattanooga 13332
FDA UDI
Class IIActive
Djo Surgical 801-01-050
FDA UDI
Class IActive
Bell-Horn 11950L
FDA UDI
Class IIActive
Djo Surgical 801-01-551
FDA UDI
Class IActive
Donjoy 11-0493-1978
FDA UDI
Class IIActive
Djo Surgical 803-00-098
FDA UDI
Class IActive
Djo Surgical 803-00-037
FDA UDI
Class IActive
Chattanooga 6874-2
FDA UDI
Class IIActive
Djo Surgical 800-01-146
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (11)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Mar 19, 2026Z-2134-2026—open, classified

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Mar 19, 2026Z-2135-2026—open, classified

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Mar 19, 2026Z-2136-2026—open, classified

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Mar 19, 2026Z-2137-2026—open, classified

Due to broken connector which may result in a temporary interruption of prescribed cold therapy.

Sep 25, 2025Z-0722-2026—open, classified

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.

Sep 7, 2021Z-0009-2022—open, classified

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.

Sep 7, 2021Z-0010-2022—open, classified

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.

Jan 17, 2019Z-1985-2019—open, classified

The product may not meet sterility requirements. Product labeled as sterile, however all units do not appear to meet sterility requirements.

Jun 25, 2018Z-2590-2020—terminated

The device accessories were not labeled with appropriate latex warning.

Aug 21, 2015Z-0121-2016—terminated

Overheating and burning of the wire insulation inside the applicator.

May 28, 2013Z-1661-2013—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).