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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 35 of 52
DeviceModel / ReferenceRegistriesClassStatus
Lightforce PRD-000424-010-01-L-L5
FDA UDI
Class IIActive
Chattanooga 42203
FDA UDI
Class IIActive
Djo Surgical 804-25-129
FDA UDI
Class IActive
Aircast 3007XXL
FDA UDI
Class IIUnknown
Djo Surgical 803-73-142
FDA UDI
Class IActive
Djo Surgical 504-42-027
FDA UDI
Class IIActive
Bell-Horn 11310M
FDA UDI
Class IIUnknown
Aircast 12A01
FDA UDI
Class IIActive
Procare 79-91333-900
FDA UDI
Class IActive
Aircast 10A
FDA UDI
Class IIActive
Bell-Horn 11832L
FDA UDI
Class IIUnknown
Djo Surgical 801-05-104
FDA UDI
Class IActive
Aircast 51A12A-0445
FDA UDI
Class IIActive
Bell-Horn 11810M
FDA UDI
Class IIActive
Bell-Horn 113102X-LONG
FDA UDI
Class IIUnknown
Djo Surgical 803-04-095
FDA UDI
Class IActive
Djo Surgical 433-32-207
FDA UDI
Class IIActive
Bell-Horn 11310M-LONG
FDA UDI
Class IIUnknown
Bell-Horn 11810XL
FDA UDI
Class IIActive
Donjoy 11-1426
FDA UDI
Class IIActive
Donjoy Performance DP151KB05-BLK-L-L
FDA UDI
Class IActive
Djo Surgical 800-01-297
FDA UDI
Class IActive
Djo Surgical 801-01-532
FDA UDI
Class IActive
Donjoy Performance DP151LS03-CAM-XL
FDA UDI
Class IActive
Chattanooga 27841
FDA UDI
Class IIActive
Djo Surgical 804-00-035
FDA UDI
Class IActive
Djo Surgical 412-01-052
FDA UDI
Class IIActive
Chattanooga 77619
FDA UDI
Class IIActive
Chattanooga 6878-4-X
FDA UDI
Class IIActive
Donjoy Performance DP151KB06-BLK-XL
FDA UDI
Class IActive
Donjoy 11-1315-0-02000
FDA UDI
Class IIActive
Chattanooga 3114
FDA UDI
Class IActive
Bell-Horn 11000XL-LONG
FDA UDI
Class IIUnknown
Djo Surgical 800-01-036
FDA UDI
Class IActive
Chattanooga 27384
FDA UDI
Class IIActive
Bell-Horn 200102X
FDA UDI
Class IIActive
Bell-Horn 11800M
FDA UDI
Class IIActive
Djo Surgical 800-01-180
FDA UDI
Class IActive
Chattanooga 2302-2
FDA UDI
Class IActive
Djo Surgical 801-01-655
FDA UDI
Class IActive
Djo Surgical 803-00-116
FDA UDI
Class IActive
Dr Comfort 132335
FDA UDI
Class IActive
Djo Surgical 800-01-295
FDA UDI
Class IActive
Compex 11-2144-2
FDA UDI
Class IIActive
Djo Surgical 494-00-050
FDA UDI
Class IIActive
Djo Surgical 803-99-018
FDA UDI
Class IActive
Donjoy 11-2015-1
FDA UDI
Class IActive
Djo Surgical 803-73-148
FDA UDI
Class IActive
Bell-Horn 11800S
FDA UDI
Class IIUnknown
Djo Surgical 804-01-036
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).