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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 1 of 52
DeviceModel / ReferenceRegistriesClassStatus
Chattanooga 42178
FDA UDI
Class IIActive
Djo Surgical 236-01-101
FDA UDI
Class IIActive
Chattanooga 2864
FDA UDI
Class IIActive
Procare 155-79-84300
FDA UDI
Class IActive
Djo Surgical 800-01-019
FDA UDI
Class IActive
Donjoy Performance DP151KS01-BLK-L
FDA UDI
Class IActive
Djo Surgical 803-05-009
FDA UDI
Class IActive
Djo Surgical 803-04-047
FDA UDI
Class IActive
Aircast 502L-4
FDA UDI
Class IIActive
Bell-Horn 113202X
FDA UDI
Class IIActive
Chattanooga 5000044
FDA UDI
Class IIActive
Djo Surgical 800-01-062
FDA UDI
Class IActive
Djo Surgical 803-88-126
FDA UDI
Class IActive
Chattanooga 1510-1
FDA UDI
Class IIActive
Chattanooga 27313
FDA UDI
Class IIActive
Chattanooga 15-0160
FDA UDI
Class IIActive
Aircast 501L-5
FDA UDI
Class IIActive
Aircast 13A01
FDA UDI
Class IIActive
Donjoy 11-0021-1
FDA UDI
Class IActive
Donjoy Performance DP151EB01-BLK-M
FDA UDI
Class IActive
Donjoy Performance DP171KS03-SGR-XL
FDA UDI
Class IActive
Procare 79-87305-4074
FDA UDI
Class IActive
Djo Surgical 803-05-077
FDA UDI
Class IActive
Donjoy Performance DP163CT04
FDA UDI
Class IActive
Procare 79-91420
FDA UDI
Class IActive
Chattanooga 77723
FDA UDI
Class IIActive
Procare 79-95727
FDA UDI
Class IActive
Djo Surgical 494-01-066
FDA UDI
Class IIActive
Djo Surgical 803-04-103
FDA UDI
Class IActive
Donjoy Performance DP181KS01-SGR-L
FDA UDI
Class IActive
Compex 11-9132
FDA UDI
Class IIActive
Bell-Horn 200003X
FDA UDI
Class IIActive
Chattanooga 27469
FDA UDI
Class IIActive
Djo Surgical 801-01-572
FDA UDI
Class IActive
Aircast 501R-4
FDA UDI
Class IIActive
Djo Surgical 431-32-207
FDA UDI
Class IIActive
Djo Surgical 801-01-645
FDA UDI
Class IActive
Procare 155-81-82393
FDA UDI
Class IActive
Procare 79-87283-0178
FDA UDI
Class IActive
Djo Surgical 803-00-091
FDA UDI
Class IActive
Djo Surgical 801-01-559
FDA UDI
Class IActive
Chattanooga 2402-2
FDA UDI
Class IActive
Djo Surgical 800-01-017
FDA UDI
Class IActive
Donjoy Performance DP151AB04-BLK-L
FDA UDI
Class IActive
Djo Surgical 803-05-069
FDA UDI
Class IActive
Bell-Horn 11935S
FDA UDI
Class IActive
Donjoy Performance DP151AB01-BLK-L-L
FDA UDI
Class IActive
Chattanooga 42159
FDA UDI
Class IIActive
Procare 79-84003-0213
FDA UDI
Class IActive
Bell-Horn 200004X
FDA UDI
Class IIActive

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).