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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 22 of 52

Device	Model / Reference	Registries	Class	Status
Dr Comfort	702414	FDA UDI	Class II	Active
Djo Surgical	804-01-008	FDA UDI	Class I	Active
Aircast	3010-PL	FDA UDI	Class II	Active
Djo Surgical	801-01-533	FDA UDI	Class I	Active
Procare	155-79-96021	FDA UDI	Class I	Active
Chattanooga	27813	FDA UDI	Class II	Active
Non Franchise	88-814000000019	FDA UDI	Class I	Active
Djo Surgical	804-01-060	FDA UDI	Class I	Active
Non Franchise	88-040000064132	FDA UDI	Class I	Active
Chattanooga	59043	FDA UDI	Class II	Active
Djo Surgical	803-04-140	FDA UDI	Class I	Active
Procare	79-87288-0213	FDA UDI	Class I	Active
Djo Surgical	804-00-139	FDA UDI	Class I	Active
Dr Comfort	132313	FDA UDI	Class I	Active
Djo Surgical	804-25-126	FDA UDI	Class I	Active
Djo Surgical	801-05-103	FDA UDI	Class I	Active
Chattanooga	39-0701	FDA UDI	Class II	Active
Bell-Horn	BH11200L-LONG	FDA UDI	Class II	Active
Djo Surgical	803-73-144	FDA UDI	Class I	Active
Donjoy Performance	DP171WW01-SGR-XL-L	FDA UDI	Class I	Active
Chattanooga	199754	FDA UDI	Class II	Active
Aircast	11-1633-0175	FDA UDI	Class II	Active
Djo Surgical	804-05-052	FDA UDI	Class I	Active
Compex	CX182BW01-L,XL	FDA UDI	Class II	Active
Donjoy Performance	DP151KB04-SGR-L	FDA UDI	Class I	Active
Djo Surgical	202-09-102	FDA UDI	Class II	Active
Donjoy Performance	DP171KS04-SGR-L	FDA UDI	Class I	Active
Djo Surgical	425-99-013S	FDA UDI	Class II	Active
Chattanooga	27382	FDA UDI	Class II	Active
Procare	155-BH-194	FDA UDI	Class I	Active
Chattanooga	5000052	FDA UDI	Class II	Active
Chattanooga	5923-3	FDA UDI	Class II	Active
Bell-Horn	11340XL	FDA UDI	Class II	Unknown
Djo Surgical	801-01-509	FDA UDI	Class I	Active
Djo Surgical	800-01-281	FDA UDI	Class I	Active
Donjoy	11-1422	FDA UDI	Class II	Active
Djo Surgical	803-03-069	FDA UDI	Class I	Active
Djo Surgical	S-200698	FDA UDI	Class I	Active
Chattanooga	10631	FDA UDI	Class I	Active
Djo Surgical	802-01-089	FDA UDI	Class I	Active
Djo Surgical	803-54-445	FDA UDI	Class I	Active
Chattanooga	27840	FDA UDI	Class II	Active
Donjoy	11-1631-8485	FDA UDI	Class II	Active
Chattanooga	5020013	FDA UDI	Class II	Active
Dr Comfort	702413	FDA UDI	Class II	Active
Compex	11-9119	FDA UDI	Class II	Active
Procare	155-81-82395	FDA UDI	Class I	Active
Djo Surgical	803-05-229	FDA UDI	Class I	Active
Chattanooga	27814	FDA UDI	Class II	Active
Aircast	3008XXL	FDA UDI	Class II	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).