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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 50 of 52

Device	Model / Reference	Registries	Class	Status
Aircast	12B01	FDA UDI	Class II	Active
Djo Surgical	80101151	FDA UDI	Class I	Active
Djo Surgical	803-73-146	FDA UDI	Class I	Active
Donjoy	11-0802-9-00000	FDA UDI	Class II	Active
Djo Surgical	400-02-058	FDA UDI	Class II	Active
Aircast	502R-3	FDA UDI	Class II	Active
Djo Surgical	801-01-241	FDA UDI	Class I	Active
Donjoy	11-0746	FDA UDI	Class II	Unknown
Donjoy	11-1630	FDA UDI	Class II	Active
Djo Surgical	804-25-127	FDA UDI	Class I	Active
Bell-Horn	11811S	FDA UDI	Class II	Unknown
Donjoy Performance	DP151LS01-SGR-L	FDA UDI	Class I	Active
Donjoy Performance	DP151LS01-SGR-XL	FDA UDI	Class I	Active
Donjoy Performance	DP151AB05-WHT-L-L	FDA UDI	Class I	Active
Donjoy Performance	DP151KB03-BLK-L,XL	FDA UDI	Class I	Active
Donjoy Performance	DP151LS03-BLK-L	FDA UDI	Class I	Active
Djo Surgical	803-05-013	FDA UDI	Class I	Active
Bell-Horn	11000L-LONG	FDA UDI	Class II	Active
Djo Surgical	803-99-016	FDA UDI	Class I	Active
Bell-Horn	11340M	FDA UDI	Class II	Unknown
Procare	79-80390	FDA UDI	Class I	Active
Chattanooga	27381	FDA UDI	Class II	Active
Djo Surgical	434-28-206	FDA UDI	Class II	Active
Djo Surgical	402-32-010	FDA UDI	Class II	Active
Djo Surgical	801-01-659	FDA UDI	Class I	Active
Aircast	3046	FDA UDI	Class II	Active
Donjoy	11-4000-0-06000	FDA UDI	Class I	Active
Donjoy Performance	DP151EB01-SGR-S	FDA UDI	Class I	Active
Donjoy Performance	DP151KB05-BLK-S-R	FDA UDI	Class I	Active
Procare	79-95525-0136	FDA UDI	Class I	Active
Bell-Horn	BH112003X-SHORT	FDA UDI	Class II	Active
Donjoy Performance	DP163CT03-BLK-L,XL	FDA UDI	Class I	Active
Bell-Horn	11931S	FDA UDI	Class I	Active
Procare	79-81102	FDA UDI	Class I	Active
Donjoy Performance	DP151KB02-SGR-S	FDA UDI	Class I	Active
Bell-Horn	11210XL-SHORT	FDA UDI	Class II	Active
Cmf	Spinalogic	FDA UDI	Class II	Active
Non Franchise	88-814000006293	FDA UDI	Class I	Active
Donjoy Performance	DP161KB02-SGR-M,L	FDA UDI	Class I	Active
Bell-Horn	11832S	FDA UDI	Class II	Unknown
Bell-Horn	11863E	FDA UDI	Class I	Active
Cmf	OL1000 Single Coil Size 2	FDA UDI	Class III	Active
Procare	79-91221	FDA UDI	Class I	Active
Procare	79-90800	FDA UDI	Class I	Active
Donjoy Performance	DP151LS03-CAM-S	FDA UDI	Class I	Active
Donjoy Performance	DP151LS02-CAM-XS	FDA UDI	Class I	Active
Bell-Horn	11570S	FDA UDI	Class II	Unknown
Procare	79-91400	FDA UDI	Class I	Active
Bell-Horn	113003X-SHORT	FDA UDI	Class II	Unknown
Bell-Horn	11960M	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).