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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 28 of 52

Device	Model / Reference	Registries	Class	Status
Chattanooga	48083	FDA UDI	Class II	Active
Djo Surgical	201-08-103	FDA UDI	Class II	Active
Djo Surgical	801-04-104	FDA UDI	Class I	Active
Chattanooga	42173	FDA UDI	Class II	Active
Aircast	501L-3	FDA UDI	Class II	Active
Donjoy Performance	DP181KB01-BLK-XL	FDA UDI	Class I	Active
Chattanooga	70010	FDA UDI	Class II	Active
Djo Surgical	801-01-515	FDA UDI	Class I	Active
Djo Surgical	801-01-525	FDA UDI	Class I	Active
Aircast	3045	FDA UDI	Class II	Active
Donjoy	11-0021-7	FDA UDI	Class I	Active
Djo Surgical	803-00-032	FDA UDI	Class I	Active
Djo Surgical	804-00-135	FDA UDI	Class I	Active
Chattanooga	8202	FDA UDI	Class I	Active
Chattanooga	42174	FDA UDI	Class II	Active
Chattanooga	1031	FDA UDI	Class II	Unknown
Djo Surgical	801-01-531	FDA UDI	Class I	Active
Donjoy Advantage	DA161FB01-BLK-L,XL	FDA UDI	Class I	Active
Djo Surgical	803-01-100	FDA UDI	Class I	Active
Bell-Horn	110003X-LONG	FDA UDI	Class II	Unknown
Djo Surgical	801-01-500	FDA UDI	Class I	Active
Chattanooga	4238	FDA UDI	Class II	Active
Donjoy Performance	DP161KB02-SGR-XS,S	FDA UDI	Class I	Active
Aircast	3007-PL	FDA UDI	Class II	Unknown
Aircast	10P01	FDA UDI	Class II	Active
Procare	79-84017-0178	FDA UDI	Class I	Active
Donjoy Performance	DP171WW01-SGR-XL-R	FDA UDI	Class I	Active
Djo Surgical	80101419	FDA UDI	Class I	Active
Djo Surgical	652-06-180L	FDA UDI	Class II	Active
Djo Surgical	233-09-103	FDA UDI	Class II	Active
Bell-Horn	11864C	FDA UDI	Class II	Unknown
Aircast	01EF-XS-0178	FDA UDI	Class I	Active
Donjoy Performance	DP171ES01-SGR-L	FDA UDI	Class I	Active
Djo Surgical	412-01-050	FDA UDI	Class II	Active
Djo Surgical	803-05-064	FDA UDI	Class I	Active
Donjoy Performance	DP171WW01-SGR-XS,S-L	FDA UDI	Class I	Active
Bell-Horn	11863C	FDA UDI	Class I	Active
Djo Surgical	804-02-009	FDA UDI	Class I	Active
Non Franchise	88-578000370511	FDA UDI	Class I	Active
Donjoy	11-1438	FDA UDI	Class II	Active
Aircast	01EF-XL-0178	FDA UDI	Class I	Active
Non Franchise	88-021000010381	FDA UDI	Class I	Active
Donjoy Performance	DP171AW02-BLK-L	FDA UDI	Class I	Active
Procare	79-81523	FDA UDI	Class I	Active
Donjoy Performance	DP161WW01-BLK-Y	FDA UDI	Class I	Active
Chattanooga	6874-6-X	FDA UDI	Class II	Active
Chattanooga	42193	FDA UDI	Class II	Active
Chattanooga	59005	FDA UDI	Class II	Active
Djo Surgical	801-01-552	FDA UDI	Class I	Active
Bell-Horn	11950S	FDA UDI	Class II	Active

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Importers

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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).