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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 48 of 52

Device	Model / Reference	Registries	Class	Status
Raw Material	13-4024	FDA UDI	Class II	Active
Procare	79-84015-0178	FDA UDI	Class I	Active
Djo Surgical	801-04-060	FDA UDI	Class I	Active
Chattanooga	42195	FDA UDI	Class II	Active
Chattanooga	42200	FDA UDI	Class II	Active
Donjoy Performance	DP151KB05-BLK-L-R	FDA UDI	Class I	Active
Djo Surgical	800-01-261	FDA UDI	Class I	Active
Djo Surgical	800-01-116	FDA UDI	Class I	Active
Aircast	11B01	FDA UDI	Class II	Active
Djo Surgical	804-25-134	FDA UDI	Class I	Active
Chattanooga	6876-2	FDA UDI	Class II	Active
Djo Surgical	803-00-086	FDA UDI	Class I	Active
Chattanooga	70005	FDA UDI	Class II	Active
Chattanooga	2502-3	FDA UDI	Class I	Active
Dr Comfort	132315	FDA UDI	Class I	Active
Chattanooga	42211	FDA UDI	Class II	Active
Non Franchise	88-002000080604	FDA UDI	Class I	Active
Djo Surgical	803-33-105	FDA UDI	Class I	Active
Djo Surgical	800-01-041	FDA UDI	Class I	Active
Bell-Horn	20020L	FDA UDI	Class II	Active
Djo Surgical	803-05-101	FDA UDI	Class I	Active
Djo Surgical	803-04-132	FDA UDI	Class I	Active
Bell-Horn	11860D	FDA UDI	Class I	Active
Djo Surgical	803-04-344	FDA UDI	Class I	Active
Bell-Horn	BH112003X	FDA UDI	Class II	Active
Bell-Horn	11970M	FDA UDI	Class II	Active
Chattanooga	77595	FDA UDI	Class II	Active
Djo Surgical	803-00-099	FDA UDI	Class I	Active
Procare	79-87298-0178	FDA UDI	Class I	Active
Djo Surgical	803-03-075	FDA UDI	Class I	Active
Donjoy Performance	DP151LS02-BLK-L	FDA UDI	Class I	Active
Djo Surgical	803-51-445	FDA UDI	Class I	Active
Bell-Horn	11935M	FDA UDI	Class I	Active
Djo Surgical	801-01-406	FDA UDI	Class I	Active
Djo Surgical	801-01-125	FDA UDI	Class I	Active
Djo Surgical	803-04-053	FDA UDI	Class I	Active
Exos	311-31-2388	FDA UDI	Class I	Active
Djo Surgical	433-32-212	FDA UDI	Class II	Active
Cmf	11-1520	FDA UDI	Class III	Unknown
Bell-Horn	11250L	FDA UDI	Class II	Active
Djo Surgical	800-01-171	FDA UDI	Class I	Active
Procare	79-91440	FDA UDI	Class I	Active
Bell-Horn	11831XL	FDA UDI	Class II	Unknown
Bell-Horn	11821M	FDA UDI	Class II	Unknown
Donjoy Performance	DP163CT06	FDA UDI	Class I	Active
Djo Surgical	80101140	FDA UDI	Class I	Active
Procare	155-79-89210	FDA UDI	Class I	Active
Djo Surgical	233-01-106S	FDA UDI	Class II	Active
Djo Surgical	402-32-005	FDA UDI	Class II	Active
Aircast	3011	FDA UDI	Class II	Unknown

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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).