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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 39 of 52

Device	Model / Reference	Registries	Class	Status
Djo Surgical	233-08-107	FDA UDI	Class II	Active
Aircast	501R-2	FDA UDI	Class II	Active
Chattanooga	59006	FDA UDI	Class II	Active
Djo Surgical	201-08-110	FDA UDI	Class II	Active
Lightforce	PRD-000758-010-00-L-L5	FDA UDI	Class II	Active
Donjoy Performance	DP151AB01-SGR-S-L	FDA UDI	Class I	Active
Donjoy Performance	DP151AB01-BLK-XL-L	FDA UDI	Class I	Active
Bell-Horn	99100S	FDA UDI	Class I	Active
Compex	506011	FDA UDI	Class II	Active
Aircast	30B-H	FDA UDI	Class II	Unknown
Compex	506012	FDA UDI	Class II	Active
Chattanooga	020453266	FDA UDI	Class II	Active
Aircast	10A01V1356	FDA UDI	Class II	Active
Non Franchise	88-578000370534	FDA UDI	Class I	Active
Chattanooga	27904K	FDA UDI	Class II	Active
Aircast	3041	FDA UDI	Class II	Active
Compex	CX192WI01	FDA UDI	Class II	Active
Procare	79-87285-0213	FDA UDI	Class I	Active
Procare	79-95525-0213	FDA UDI	Class I	Active
Djo Surgical	402-28-010	FDA UDI	Class II	Active
Donjoy Performance	DP171KS04-SGR-XL	FDA UDI	Class I	Active
Aircast	3008XXXL	FDA UDI	Class II	Active
Dr Comfort	701434	FDA UDI	Class II	Active
Djo Surgical	801-01-550	FDA UDI	Class I	Active
Bell-Horn	11000XL	FDA UDI	Class II	Active
Procare	79-80360	FDA UDI	Class I	Active
Djo Surgical	433-32-211	FDA UDI	Class II	Active
Djo Surgical	803-03-065	FDA UDI	Class I	Active
Chattanooga	1032-B	FDA UDI	Class II	Active
Bell-Horn	20020XL	FDA UDI	Class II	Active
Procare	79-95712	FDA UDI	Class I	Active
Procare	79-95728	FDA UDI	Class I	Active
Procare	79-95517-0100	FDA UDI	Class I	Active
Procare	79-91643	FDA UDI	Class I	Active
Djo Surgical	801-01-548	FDA UDI	Class I	Active
Donjoy Performance	DP147DS01-BLK-450	FDA UDI	Class I	Active
Donjoy Advantage	DA201KW01-BLK-S,M	FDA UDI	Class I	Active
Donjoy	11-0611-9-00000	FDA UDI	Class II	Active
Donjoy Performance	DP151AB01-SGR-M-L	FDA UDI	Class I	Active
Djo Surgical	800-03-035	FDA UDI	Class I	Active
Djo Surgical	800-01-053	FDA UDI	Class I	Active
Donjoy Performance	DP151AB03-BLK-M-R	FDA UDI	Class I	Active
Djo Surgical	803-04-093	FDA UDI	Class I	Active
Djo Surgical	933-36-772	FDA UDI	Class II	Active
Chattanooga	2502	FDA UDI	Class I	Active
Chattanooga	2761-10	FDA UDI	Class II	Active
Procare	155-79-89091	FDA UDI	Class I	Active
Donjoy Performance	DP181KB01-BLK-M	FDA UDI	Class I	Active
Chattanooga	2758	FDA UDI	Class II	Active
Aircast	51A11B-0445	FDA UDI	Class II	Active

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Authorities

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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).