Is this your brand? Sign in to claim ownership.

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 10 of 52

Device	Model / Reference	Registries	Class	Status
Djo Surgical	431-28-206	FDA UDI	Class II	Active
Chattanooga	42205	FDA UDI	Class II	Active
Procare	79-81318-900	FDA UDI	Class I	Active
Procare	79-87318-4074	FDA UDI	Class I	Active
Djo Surgical	412-01-046	FDA UDI	Class II	Active
Chattanooga	2795-2	FDA UDI	Class II	Active
Djo Surgical	803-00-120	FDA UDI	Class I	Active
Djo Surgical	800-01-139	FDA UDI	Class I	Active
Donjoy	11-0450-3-06000	FDA UDI	Class I	Active
Chattanooga	42194	FDA UDI	Class II	Active
Djo Surgical	800-01-181	FDA UDI	Class I	Active
Aircast	25-0238	FDA UDI	Class II	Active
Empi	3217	FDA UDI	Class II	Active
Donjoy Performance	DP151EB02-SGR-L	FDA UDI	Class I	Active
Djo Surgical	202-09-104	FDA UDI	Class II	Active
Djo Surgical	800-01-144	FDA UDI	Class I	Active
Procare	155-81-97045	FDA UDI	Class I	Active
Aircast	52A11B	FDA UDI	Class II	Active
Djo Surgical	804-25-041	FDA UDI	Class I	Active
Djo Surgical	803-05-068	FDA UDI	Class I	Active
Djo Surgical	803-04-090	FDA UDI	Class I	Active
Aircast	502L-6	FDA UDI	Class II	Active
Donjoy	11-1422-9	FDA UDI	Class II	Active
Bell-Horn	111103X	FDA UDI	Class II	Active
Donjoy	11-1636-1978	FDA UDI	Class II	Active
Donjoy Advantage	DA161AV02-TAN-M	FDA UDI	Class I	Active
Djo Surgical	800-01-113	FDA UDI	Class I	Active
Bell-Horn	11300M	FDA UDI	Class II	Active
Bell-Horn	11812S	FDA UDI	Class I	Active
Djo Surgical	434-28-207	FDA UDI	Class II	Active
Bell-Horn	11955M	FDA UDI	Class I	Active
Bell-Horn	11310L-LONG	FDA UDI	Class II	Unknown
Aircast	3111-020	FDA UDI	Class I	Active
Djo Surgical	800-01-142	FDA UDI	Class I	Active
Djo Surgical	801-01-514	FDA UDI	Class I	Active
Djo Surgical	801-01-001	FDA UDI	Class I	Active
Donjoy Performance	DP191KS01-SGR-S	FDA UDI	Class I	Active
Procare	79-81355-900	FDA UDI	Class I	Active
Procare	155-79-87073	FDA UDI	Class I	Active
Donjoy Performance	DP151LS03-CAM-M	FDA UDI	Class I	Active
Djo Surgical	801-04-083	FDA UDI	Class I	Active
Djo Surgical	804-01-013	FDA UDI	Class I	Active
Djo Surgical	801-01-512	FDA UDI	Class I	Active
Donjoy Performance	DP163CT01-BLK-S,M	FDA UDI	Class I	Active
Djo Surgical	803-05-049	FDA UDI	Class I	Active
Aircast	10C	FDA UDI	Class II	Active
Donjoy Performance	DP151KS04-SGR-M	FDA UDI	Class I	Active
Donjoy	11-0675-9-00000	FDA UDI	Class II	Active
Donjoy Performance	DP151AB05-BLK-S-R	FDA UDI	Class I	Active
Djo Surgical	802-01-066	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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).