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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 18 of 52

Device	Model / Reference	Registries	Class	Status
Aircast	11A01	FDA UDI	Class II	Active
Chattanooga	4248	FDA UDI	Class II	Active
Bell-Horn	11812XL	FDA UDI	Class I	Active
Djo Surgical	804-02-006	FDA UDI	Class I	Active
Non Franchise	88-040000066751	FDA UDI	Class I	Active
Djo Surgical	803-99-015	FDA UDI	Class I	Active
Djo Surgical	802-01-082	FDA UDI	Class I	Active
Djo Surgical	803-50-002	FDA UDI	Class I	Active
Djo Surgical	438-01-007	FDA UDI	Class II	Active
Djo Surgical	803-05-150	FDA UDI	Class I	Active
Djo Surgical	434-28-211	FDA UDI	Class II	Active
Aircast	0146R	FDA UDI	Class I	Active
Bell-Horn	110002X-SHORT	FDA UDI	Class II	Unknown
Non Franchise	88-108000179499	FDA UDI	Class I	Active
Donjoy Performance	DP151KB05-SGR-M-L	FDA UDI	Class I	Active
Djo Surgical	801-01-561	FDA UDI	Class I	Active
Djo Surgical	804-25-147	FDA UDI	Class I	Active
Donjoy Performance	DP151KB07-BLK-XS,S	FDA UDI	Class I	Active
Djo Surgical	803-55-444	FDA UDI	Class I	Active
Chattanooga	59047	FDA UDI	Class II	Active
Bell-Horn	11960S	FDA UDI	Class II	Active
Djo Surgical	803-06-024	FDA UDI	Class I	Active
Compex	11-2143-4	FDA UDI	Class II	Active
Bell-Horn	BH11200L	FDA UDI	Class II	Active
Djo Surgical	324-01-103	FDA UDI	Class II	Active
Aircast	51A11B	FDA UDI	Class II	Active
Djo Surgical	803-06-018	FDA UDI	Class I	Active
Donjoy Performance	DP171KS01-SGR-S	FDA UDI	Class I	Active
Donjoy Performance	DP171AB01-BLK-S	FDA UDI	Class I	Active
Djo Surgical	802-05-003	FDA UDI	Class I	Active
Chattanooga	2802	FDA UDI	Class I	Active
Djo Surgical	801-03-009	FDA UDI	Class I	Active
Donjoy	11-0682-9-00000	FDA UDI	Class II	Active
Bell-Horn	11954XL	FDA UDI	Class II	Active
Djo Surgical	438-01-002	FDA UDI	Class II	Active
Djo Surgical	801-01-240	FDA UDI	Class I	Active
Djo Surgical	803-03-060	FDA UDI	Class I	Active
Bell-Horn	11800XL	FDA UDI	Class II	Active
Djo Surgical	800-01-183	FDA UDI	Class I	Active
Chattanooga	020453267	FDA UDI	Class II	Active
Chattanooga	39-0745	FDA UDI	Class II	Active
Djo Surgical	804-02-015	FDA UDI	Class I	Active
Chattanooga	4766	FDA UDI	Class II	Active
Chattanooga	2866	FDA UDI	Class II	Active
Djo Surgical	80101156	FDA UDI	Class I	Active
Donjoy Performance	DP151KB04-CAM-S	FDA UDI	Class I	Active
Djo Surgical	803-04-098	FDA UDI	Class I	Active
Djo Surgical	804-02-014	FDA UDI	Class I	Active
Procare	155-79-81238	FDA UDI	Class I	Active
Djo Surgical	800-01-052	FDA UDI	Class I	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).