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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 51 of 52

Device	Model / Reference	Registries	Class	Status
Procare	79-81525	FDA UDI	Class I	Active
Procare	79-87287-0213	FDA UDI	Class I	Active
Bell-Horn	11853B	FDA UDI	Class II	Unknown
Procare	79-87295-0178	FDA UDI	Class I	Active
Bell-Horn	11850D	FDA UDI	Class I	Active
Bell-Horn	11560S	FDA UDI	Class II	Active
Bell-Horn	11550S	FDA UDI	Class II	Active
Procare	79-90870	FDA UDI	Class I	Active
Procare	79-95518-0100	FDA UDI	Class I	Active
Donjoy Performance	DP151EB01-CAM-M	FDA UDI	Class I	Active
Bell-Horn	11960L	FDA UDI	Class II	Active
Bell-Horn	111102X	FDA UDI	Class II	Active
Procare	79-91490	FDA UDI	Class I	Active
Procare	79-91100	FDA UDI	Class I	Active
Procare	79-90177	FDA UDI	Class I	Active
Donjoy Performance	DP151KB01-BLK-S	FDA UDI	Class I	Active
Procare	155-BH82710	FDA UDI	Class I	Active
Donjoy	11-1269-9-00000	FDA UDI	Class II	Active
Procare	79-95703	FDA UDI	Class I	Active
Non Franchise	88-040000048494	FDA UDI	Class I	Active
Donjoy Performance	DP151KS02-BLK-S	FDA UDI	Class I	Active
Bell-Horn	11850A	FDA UDI	Class I	Active
Donjoy Performance	DP151KB05-BLK-M-L	FDA UDI	Class I	Active
Non Franchise	88-040000038387	FDA UDI	Class I	Active
Procare	79-91430	FDA UDI	Class I	Active
Bell-Horn	11340L	FDA UDI	Class II	Active
Donjoy Performance	DP151AB01-SGR-M-R	FDA UDI	Class I	Active
Non Franchise	88-021000010383	FDA UDI	Class I	Active
Donjoy Performance	DP171AV01-SGR-S	FDA UDI	Class I	Active
Donjoy Advantage	DA201KW01-BLK-L,XL	FDA UDI	Class I	Active
Procare	79-91480	FDA UDI	Class I	Active
Donjoy Performance	DP151KB01-BLK-XL	FDA UDI	Class I	Active
Procare	155-79-87072	FDA UDI	Class I	Active
Donjoy Performance	DP151EB01-BLK-L	FDA UDI	Class I	Active
Bell-Horn	BH11200M-SHORT	FDA UDI	Class II	Active
Bell-Horn	11831S	FDA UDI	Class II	Unknown
Dr Comfort	131315	FDA UDI	Class I	Active
Bell-Horn	11000M-LONG	FDA UDI	Class II	Unknown
Bell-Horn	113003X-LONG	FDA UDI	Class II	Unknown
Procare	79-90173	FDA UDI	Class I	Active
Donjoy	11-1316-0-02000	FDA UDI	Class II	Active
Procare	155-81-87313	FDA UDI	Class I	Active
Bell-Horn	112483X	FDA UDI	Class II	Active
Donjoy Performance	DP151KS01-CAM-XS	FDA UDI	Class I	Active
Donjoy	11-1638-1978	FDA UDI	Class II	Active
Donjoy Performance	DP151LS01-SGR-M	FDA UDI	Class I	Active
Donjoy Performance	DP171KS02-SGR-XL	FDA UDI	Class I	Active
Bell-Horn	11934L	FDA UDI	Class II	Unknown
Donjoy	11-0612-9-00000	FDA UDI	Class II	Active
Donjoy Advantage	5548250	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).