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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 25 of 52

Device	Model / Reference	Registries	Class	Status
Djo Surgical	804-02-078	FDA UDI	Class I	Active
Chattanooga	02200002	FDA UDI	Class II	Active
Bell-Horn	11952L	FDA UDI	Class I	Active
Bell-Horn	11864B	FDA UDI	Class II	Unknown
Bell-Horn	11800L	FDA UDI	Class II	Active
Compex	42223	FDA UDI	Class II	Active
Procare	155-79-87083	FDA UDI	Class I	Active
Donjoy	11-0021-4	FDA UDI	Class I	Active
Djo Surgical	800-04-087	FDA UDI	Class I	Active
Procare	79-95522-0213	FDA UDI	Class I	Active
Djo Surgical	800-01-386	FDA UDI	Class I	Active
Donjoy Performance	DP151KS02-CAM-XL	FDA UDI	Class I	Active
Aircast	10P	FDA UDI	Class II	Active
Chattanooga	2102-2	FDA UDI	Class I	Active
Cmf	OL1000 Dual Coil	FDA UDI	Class II	Active
Donjoy	11-1629	FDA UDI	Class II	Active
Chattanooga	6878-6	FDA UDI	Class II	Active
Chattanooga	19365	FDA UDI	Class II	Active
Chattanooga	4738	FDA UDI	Class II	Active
Compex	42214	FDA UDI	Class II	Active
Djo Surgical	803-53-381	FDA UDI	Class I	Active
Procare	79-87307-4074	FDA UDI	Class I	Active
Chattanooga	2841	FDA UDI	Class II	Active
Donjoy Advantage	DA161WB01-GRY-M,L-R	FDA UDI	Class I	Active
Djo Surgical	803-00-030	FDA UDI	Class I	Active
Bell-Horn	BH11350XL	FDA UDI	Class II	Active
Chattanooga	6878-1-X	FDA UDI	Class II	Active
Bell-Horn	BH112002X-SHORT	FDA UDI	Class II	Active
Bell-Horn	11940XL	FDA UDI	Class II	Active
Bell-Horn	11110S-SHORT	FDA UDI	Class II	Active
Djo Surgical	233-09-102	FDA UDI	Class II	Active
Chattanooga	42171	FDA UDI	Class II	Active
Djo Surgical	803-04-067	FDA UDI	Class I	Active
Donjoy	25-1139-0-00000	FDA UDI	Class I	Active
Compex	CX192WI02	FDA UDI	Class II	Active
Djo Surgical	802-05-004	FDA UDI	Class I	Active
Donjoy	11-9098	FDA UDI	Class II	Active
Non Franchise	88-814000004021	FDA UDI	Class I	Active
Donjoy Performance	DP171ES01-SGR-XL	FDA UDI	Class I	Active
Compex	601131	FDA UDI	Class II	Active
Djo Surgical	201-08-102	FDA UDI	Class II	Active
Djo Surgical	435-28-209	FDA UDI	Class II	Active
Djo Surgical	933-36-780	FDA UDI	Class II	Active
Non Franchise	88-002000080704	FDA UDI	Class I	Active
Chattanooga	FLU115D	FDA UDI	Class II	Active
Bell-Horn	BH11200XL	FDA UDI	Class II	Active
Djo Surgical	803-05-008	FDA UDI	Class I	Active
Djo Surgical	800-99-009	FDA UDI	Class I	Active
Raw Material	30M	FDA UDI	Class II	Active
Djo Surgical	804-00-037	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).