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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 12 of 52
DeviceModel / ReferenceRegistriesClassStatus
Djo Surgical 80101142
FDA UDI
Class IActive
Aircast 01EF-M-0178
FDA UDI
Class IActive
Chattanooga 2764
FDA UDI
Class IIActive
Djo Surgical 803-06-015
FDA UDI
Class IActive
Chattanooga 2102-3
FDA UDI
Class IActive
Djo Surgical 803-04-092
FDA UDI
Class IActive
Chattanooga 2407
FDA UDI
Class IActive
Procare 79-91175
FDA UDI
Class IActive
Djo Surgical 803-04-096
FDA UDI
Class IActive
Procare 155-79-87077
FDA UDI
Class IActive
Bell-Horn 112103X
FDA UDI
Class IIActive
Compex 11-2139
FDA UDI
Class IIActive
Aircast 24-3042
FDA UDI
Class IIActive
Djo Surgical 803-00-108
FDA UDI
Class IActive
Donjoy Performance DP151KB02-SGR-L
FDA UDI
Class IActive
Donjoy Performance DP151AB02-BLK-M
FDA UDI
Class IActive
Chattanooga 2772MC
FDA UDI
Class IIActive
Donjoy 11-0471-9
FDA UDI
Class IActive
Bell-Horn 11310XL-SHORT
FDA UDI
Class IIUnknown
Djo Surgical 800-01-358
FDA UDI
Class IActive
Djo Surgical 933-44-776
FDA UDI
Class IIActive
Chattanooga 5900
FDA UDI
Class IIActive
Djo Surgical 494-00-066
FDA UDI
Class IIActive
Non Franchise 88-040000484823
FDA UDI
Class IActive
Procare 155-14040S-M
FDA UDI
Class IActive
Chattanooga 77630
FDA UDI
Class IIActive
Bell-Horn 11813L
FDA UDI
Class IActive
Donjoy 11-1371-4-7797
FDA UDI
Class IActive
Djo Surgical 800-99-011
FDA UDI
Class IActive
Chattanooga 28495
FDA UDI
Class IIActive
Chattanooga 27802
FDA UDI
Class IIActive
Chattanooga 199753
FDA UDI
Class IIActive
Donjoy Performance DP211KB01-USA-M
FDA UDI
Class IActive
Djo Surgical 803-20-040
FDA UDI
Class IActive
Donjoy Performance DP151LS01-BLK-M
FDA UDI
Class IActive
Bell-Horn 11310S
FDA UDI
Class IIUnknown
Procare 155-79-84027
FDA UDI
Class IActive
Compex 506012TENS
FDA UDI
Class IIActive
Chattanooga 42206
FDA UDI
Class IIActive
Bell-Horn 11248L
FDA UDI
Class IIActive
Djo Surgical 802-01-102
FDA UDI
Class IActive
Bell-Horn 11811XL
FDA UDI
Class IIActive
Donjoy Performance DP151AB05-BLK-XS-L
FDA UDI
Class IActive
Djo Surgical 803-05-086
FDA UDI
Class IActive
Donjoy Performance DP151KB05-SGR-M-R
FDA UDI
Class IActive
Djo Surgical 803-04-091
FDA UDI
Class IActive
Djo Surgical 932-44-772
FDA UDI
Class IIActive
Cmf OL1000 Single Coil Size 4
FDA UDI
Class IIIActive
Procare 79-91647
FDA UDI
Class IActive
Dr Comfort 131314
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).