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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 19 of 52

Device	Model / Reference	Registries	Class	Status
Donjoy	11-0813-9-00000	FDA UDI	Class II	Active
Djo Surgical	803-04-134	FDA UDI	Class I	Active
Chattanooga	2402-4	FDA UDI	Class I	Active
Aircast	500R-7	FDA UDI	Class II	Active
Chattanooga	73636	FDA UDI	Class II	Active
Bell-Horn	11932XL	FDA UDI	Class I	Active
Compex	001062-SP	FDA UDI	Class II	Active
Djo Surgical	400-02-050	FDA UDI	Class II	Active
Chattanooga	020453217	FDA UDI	Class II	Active
Djo Surgical	801-05-016	FDA UDI	Class I	Active
Donjoy Performance	DP151EB01-BLK-XL	FDA UDI	Class I	Active
Procare	79-91110	FDA UDI	Class I	Active
Djo Surgical	931-40-760	FDA UDI	Class II	Active
Djo Surgical	804-06-012	FDA UDI	Class I	Active
Bell-Horn	113103X	FDA UDI	Class II	Unknown
Chattanooga	27900K-SP	FDA UDI	Class II	Active
Djo Surgical	803-05-006	FDA UDI	Class I	Active
Procare	79-87285-0178	FDA UDI	Class I	Active
Djo Surgical	801-01-536	FDA UDI	Class I	Active
Djo Surgical	801-01-121	FDA UDI	Class I	Active
Djo Surgical	804-05-112	FDA UDI	Class I	Active
Chattanooga	8245-X	FDA UDI	Class II	Active
Chattanooga	2796	FDA UDI	Class II	Active
Djo Surgical	652-05-165L	FDA UDI	Class II	Active
Djo Surgical	800-01-378	FDA UDI	Class I	Active
Djo Surgical	801-01-414	FDA UDI	Class I	Active
Donjoy	11-1633	FDA UDI	Class II	Active
Chattanooga	2760	FDA UDI	Class II	Active
Aircast	01F231	FDA UDI	Class I	Active
Djo Surgical	80101152	FDA UDI	Class I	Active
Procare	79-87282-0213	FDA UDI	Class I	Active
Dr Comfort	131333	FDA UDI	Class I	Active
Donjoy Performance	DP151AB03-BLK-S-L	FDA UDI	Class I	Active
Aircast	32B	FDA UDI	Class II	Unknown
Djo Surgical	802-01-083	FDA UDI	Class I	Active
Djo Surgical	233-08-108	FDA UDI	Class II	Active
Aircast	3008XL	FDA UDI	Class II	Active
Chattanooga	2782-2	FDA UDI	Class II	Active
Compex	11-2142	FDA UDI	Class II	Active
Djo Surgical	932-36-760	FDA UDI	Class II	Active
Aircast	01EF-L-0178	FDA UDI	Class I	Active
Bell-Horn	200103X	FDA UDI	Class II	Active
Bell-Horn	11812M	FDA UDI	Class I	Active
Djo Surgical	802-01-069	FDA UDI	Class I	Active
Chattanooga	12214	FDA UDI	Class II	Active
Djo Surgical	80101420	FDA UDI	Class I	Active
Procare	79-95732	FDA UDI	Class I	Active
Chattanooga	57007	FDA UDI	Class II	Active
Donjoy Performance	DP171KS03-SGR-L	FDA UDI	Class I	Active
Djo Surgical	801-03-011	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).