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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 8 of 52

Device	Model / Reference	Registries	Class	Status
Djo Surgical	435-28-207	FDA UDI	Class II	Active
Chattanooga	28098	FDA UDI	Class II	Active
Djo Surgical	803-73-140	FDA UDI	Class I	Active
Djo Surgical	932-36-756	FDA UDI	Class II	Active
Procare	79-91179	FDA UDI	Class I	Active
Procare	79-87293-0213	FDA UDI	Class I	Active
Chattanooga	42176	FDA UDI	Class II	Active
Donjoy Performance	DP151AB05-WHT-M-R	FDA UDI	Class I	Active
Djo Surgical	802-01-072	FDA UDI	Class I	Active
Djo Surgical	803-04-018	FDA UDI	Class I	Active
Djo Surgical	80101422	FDA UDI	Class I	Active
Djo Surgical	652-07-195R	FDA UDI	Class II	Active
Bell-Horn	11831L	FDA UDI	Class II	Unknown
Bell-Horn	11310M-SHORT	FDA UDI	Class II	Unknown
Donjoy	11-1317-0-02000	FDA UDI	Class II	Unknown
Djo Surgical	800-01-095	FDA UDI	Class I	Active
Non Franchise	88-578000372183	FDA UDI	Class I	Active
Djo Surgical	801-01-549	FDA UDI	Class I	Active
Djo Surgical	804-05-047	FDA UDI	Class I	Active
Donjoy Performance	DP151KB02-BLK-L	FDA UDI	Class I	Active
Chattanooga	15-0162	FDA UDI	Class II	Active
Aircast	3016-PL	FDA UDI	Class II	Active
Aircast	500R-4	FDA UDI	Class II	Active
Donjoy	11-1268-9-00000	FDA UDI	Class II	Active
Djo Surgical	494-01-054	FDA UDI	Class II	Active
Bell-Horn	BH11200L-SHORT	FDA UDI	Class II	Active
Djo Surgical	801-01-516	FDA UDI	Class I	Active
Djo Surgical	803-05-231	FDA UDI	Class I	Active
Aircast	3013	FDA UDI	Class II	Active
Procare	155-81-87307	FDA UDI	Class I	Active
Donjoy Performance	DP181KS01-SGR-S	FDA UDI	Class I	Active
Djo Surgical	800-01-100	FDA UDI	Class I	Active
Chattanooga	12661	FDA UDI	Class II	Active
Donjoy Performance	DP191KS01-SGR-M	FDA UDI	Class I	Active
Chattanooga	42202	FDA UDI	Class II	Active
Djo Surgical	801-01-527	FDA UDI	Class I	Active
Chattanooga	59054	FDA UDI	Class II	Active
Djo Surgical	801-01-661	FDA UDI	Class I	Active
Donjoy Performance	DP151KS04-SGR-L	FDA UDI	Class I	Active
Bell-Horn	11340S	FDA UDI	Class II	Unknown
Companion	PRD-001005-000	FDA UDI	Class I	Active
Bell-Horn	11853A	FDA UDI	Class II	Unknown
Djo Surgical	233-09-106	FDA UDI	Class II	Active
Donjoy Performance	DP171AV02-SGR-L	FDA UDI	Class I	Active
Bell-Horn	11320L	FDA UDI	Class II	Active
Donjoy Performance	DP151LS03-BLK-S	FDA UDI	Class I	Active
Chattanooga	70008	FDA UDI	Class II	Active
Djo Surgical	803-04-044	FDA UDI	Class I	Active
Aircast	502S-5	FDA UDI	Class II	Active
Bell-Horn	11110XL-LONG	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).