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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 38 of 52
DeviceModel / ReferenceRegistriesClassStatus
Djo Surgical 802-01-065
FDA UDI
Class IActive
Djo Surgical 804-02-017
FDA UDI
Class IActive
Aircast 30B-SB
FDA UDI
Class IIActive
Djo Surgical 803-05-052
FDA UDI
Class IActive
Aircast 500L-2
FDA UDI
Class IIActive
Chattanooga 1030
FDA UDI
Class IIUnknown
Donjoy Performance DP157KS01-BLK-S
FDA UDI
Class IActive
Donjoy Performance DP151EB02-BLK-S
FDA UDI
Class IActive
Djo Surgical 80101165
FDA UDI
Class IActive
Djo Surgical 803-03-064
FDA UDI
Class IActive
Djo Surgical 803-05-078
FDA UDI
Class IActive
Djo Surgical 402-32-000
FDA UDI
Class IIActive
Exos 311-32-1111
FDA UDI
Class IActive
Non Franchise 88-578000235243
FDA UDI
Class IActive
Donjoy 11-1425
FDA UDI
Class IIActive
Aircast 01K-XLR
FDA UDI
Class IActive
Djo Surgical 801-01-562
FDA UDI
Class IActive
Djo Surgical 800-01-031
FDA UDI
Class IActive
Djo Surgical 801-01-558
FDA UDI
Class IActive
Bell-Horn 11934M
FDA UDI
Class IIUnknown
Djo Surgical 80101731
FDA UDI
Class IActive
Chattanooga 20719
FDA UDI
Class IActive
Djo Surgical 233-09-104
FDA UDI
Class IIActive
Procare 155-81-97048
FDA UDI
Class IActive
Djo Surgical S-200860
FDA UDI
Class IActive
Djo Surgical 804-01-037
FDA UDI
Class IActive
Djo Surgical 932-36-772
FDA UDI
Class IIActive
Compex 6250900
FDA UDI
Class IIActive
Djo Surgical 802-01-064
FDA UDI
Class IActive
Compex 506110
FDA UDI
Class IIActive
Chattanooga 2402-1
FDA UDI
Class IActive
Procare 79-95515-0136
FDA UDI
Class IActive
Procare 79-91460
FDA UDI
Class IActive
Djo Surgical 803-61-105
FDA UDI
Class IActive
Djo Surgical 801-01-544
FDA UDI
Class IActive
Djo Surgical 803-05-047
FDA UDI
Class IActive
Donjoy Performance DP151KB05-BLK-XL-R
FDA UDI
Class IActive
Chattanooga 42177
FDA UDI
Class IIActive
Djo Surgical 800-01-075
FDA UDI
Class IActive
Donjoy Performance DP151KS01-CAM-S
FDA UDI
Class IActive
Djo Surgical 803-84-438
FDA UDI
Class IActive
Djo Surgical 802-01-081
FDA UDI
Class IActive
Chattanooga 5951
FDA UDI
Class IIActive
Chattanooga 4002
FDA UDI
Class IActive
Donjoy Performance DP171AV02-SGR-XL
FDA UDI
Class IActive
Djo Surgical 431-22-204
FDA UDI
Class IIActive
Bell-Horn 118103X
FDA UDI
Class IIActive
Djo Surgical 432-28-209
FDA UDI
Class IIActive
Bell-Horn 11970S
FDA UDI
Class IIActive
Djo Surgical 803-20-041
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).