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DJO, LLC

Last updated September 17, 2026

Information

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

Catalogue (2587)

Page 5 of 52

Device	Model / Reference	Registries	Class	Status
Bell-Horn	11822L	FDA UDI	Class II	Unknown
Djo Surgical	803-04-094	FDA UDI	Class I	Active
Djo Surgical	803-00-112	FDA UDI	Class I	Active
Djo Surgical	803-04-019	FDA UDI	Class I	Active
Lightforce	PRD-000424-010-01-L-G5	FDA UDI	Class II	Active
Bell-Horn	99100M	FDA UDI	Class I	Active
Djo Surgical	201-08-105	FDA UDI	Class II	Active
Procare	79-87292-0178	FDA UDI	Class I	Active
Aircast	2128	FDA UDI	Class II	Active
Donjoy Advantage	DA161AV01-BLK-S	FDA UDI	Class I	Active
Bell-Horn	11860B	FDA UDI	Class I	Active
Djo Surgical	801-01-308	FDA UDI	Class I	Active
Donjoy Performance	DP151AB02-BLK-S	FDA UDI	Class I	Active
Aircast	51A14A	FDA UDI	Class II	Active
Chattanooga	8201	FDA UDI	Class I	Active
Djo Surgical	933-44-780	FDA UDI	Class II	Active
Procare	155-79-87087	FDA UDI	Class I	Active
Chattanooga	70004	FDA UDI	Class II	Active
Donjoy Performance	DP171AB01-BLK-XL	FDA UDI	Class I	Active
Djo Surgical	400-02-040	FDA UDI	Class II	Active
Donjoy Performance	DP151KS02-CAM-XS	FDA UDI	Class I	Active
Aircast	51A12A	FDA UDI	Class II	Active
Donjoy Performance	DP171KS03-SGR-S	FDA UDI	Class I	Active
Procare	79-91173	FDA UDI	Class I	Active
Djo Surgical	412-01-042	FDA UDI	Class II	Active
Donjoy Performance	DP151KB04-BLK-XL	FDA UDI	Class I	Active
Chattanooga	8205	FDA UDI	Class I	Active
Bell-Horn	11250XL	FDA UDI	Class II	Active
Donjoy	11-1522	FDA UDI	Class II	Active
Djo Surgical	800-01-185	FDA UDI	Class I	Active
Djo Surgical	438-01-006	FDA UDI	Class II	Active
Bell-Horn	11822XL	FDA UDI	Class II	Unknown
Djo Surgical	803-04-003	FDA UDI	Class I	Active
Chattanooga	2797	FDA UDI	Class II	Active
Djo Surgical	80101169	FDA UDI	Class I	Active
Aircast	2125	FDA UDI	Class II	Active
Djo Surgical	804-02-089	FDA UDI	Class I	Active
Donjoy Performance	DP151KB05-BLK-XL-L	FDA UDI	Class I	Active
Djo Surgical	804-00-096	FDA UDI	Class I	Active
Donjoy Performance	DP171AV02-SGR-M	FDA UDI	Class I	Active
Djo Surgical	803-00-110	FDA UDI	Class I	Active
Chattanooga	27377	FDA UDI	Class II	Active
Djo Surgical	800-01-286	FDA UDI	Class I	Active
Djo Surgical	932-40-768	FDA UDI	Class II	Active
Donjoy	3-0494	FDA UDI	Class II	Active
Chattanooga	27799	FDA UDI	Class II	Active
Djo Surgical	803-84-238	FDA UDI	Class I	Active
Chattanooga	2781	FDA UDI	Class II	Active
Bell-Horn	11863D	FDA UDI	Class I	Active
Djo Surgical	804-05-091	FDA UDI	Class I	Active

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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.

Date	Recall No.	Class	Status	Reason
Mar 19, 2026	Z-2134-2026	—	open, classified	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Mar 19, 2026	Z-2135-2026	—	open, classified	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Mar 19, 2026	Z-2136-2026	—	open, classified	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Mar 19, 2026	Z-2137-2026	—	open, classified	Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
Sep 25, 2025	Z-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, 2021	Z-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, 2021	Z-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, 2019	Z-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, 2018	Z-2590-2020	—	terminated	The device accessories were not labeled with appropriate latex warning.
Aug 21, 2015	Z-0121-2016	—	terminated	Overheating and burning of the wire insulation inside the applicator.
May 28, 2013	Z-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).