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 36 of 52

Device	Model / Reference	Registries	Class	Status
Donjoy Performance	DP151EB01-SGR-XL	FDA UDI	Class I	Active
Chattanooga	1600	FDA UDI	Class II	Active
Bell-Horn	118003X	FDA UDI	Class II	Active
Djo Surgical	80101163	FDA UDI	Class I	Active
Chattanooga	77720	FDA UDI	Class II	Active
Djo Surgical	202-09-110	FDA UDI	Class II	Active
Aircast	01K-XLL	FDA UDI	Class I	Active
Aircast	30BI	FDA UDI	Class II	Active
Donjoy	11-1635-1978	FDA UDI	Class II	Active
Aircast	10A01-211	FDA UDI	Class II	Unknown
Djo Surgical	800-01-118	FDA UDI	Class I	Active
Aircast	3042	FDA UDI	Class II	Active
Djo Surgical	801-01-450	FDA UDI	Class I	Active
Procare	79-95523-0213	FDA UDI	Class I	Active
Procare	79-84013-0178	FDA UDI	Class I	Active
Procare	79-95705	FDA UDI	Class I	Active
Djo Surgical	804-03-010	FDA UDI	Class I	Active
Djo Surgical	434-28-209	FDA UDI	Class II	Active
Aircast	3014-PL	FDA UDI	Class II	Unknown
Djo Surgical	801-01-265	FDA UDI	Class I	Active
Compex	11-9133	FDA UDI	Class II	Active
Chattanooga	6876-1-X	FDA UDI	Class II	Active
Chattanooga	2782	FDA UDI	Class II	Active
Bell-Horn	11955L	FDA UDI	Class I	Active
Djo Surgical	801-01-546	FDA UDI	Class I	Active
Djo Surgical	804-25-144	FDA UDI	Class I	Active
Bell-Horn	11860E	FDA UDI	Class I	Active
Non Franchise	88-021000011053	FDA UDI	Class I	Active
Djo Surgical	80101162	FDA UDI	Class I	Active
Aircast	502R-2	FDA UDI	Class II	Active
Djo Surgical	803-05-082	FDA UDI	Class I	Active
Chattanooga	1821	FDA UDI	Class I	Active
Djo Surgical	803-05-083	FDA UDI	Class I	Active
Djo Surgical	801-01-545	FDA UDI	Class I	Active
Bell-Horn	115503X	FDA UDI	Class II	Unknown
Djo Surgical	801-04-080	FDA UDI	Class I	Active
Djo Surgical	803-04-002	FDA UDI	Class I	Active
Dr Comfort	132314	FDA UDI	Class I	Active
Djo Surgical	803-05-079	FDA UDI	Class I	Active
Djo Surgical	803-04-101	FDA UDI	Class I	Active
Non Franchise	88-578000372163	FDA UDI	Class I	Active
Chattanooga	199614	FDA UDI	Class I	Active
Donjoy Performance	DP181BB01-SGR	FDA UDI	Class I	Active
Donjoy Performance	DP151KS01-CAM-L	FDA UDI	Class I	Active
Djo Surgical	803-04-097	FDA UDI	Class I	Active
Djo Surgical	803-04-144	FDA UDI	Class I	Active
Donjoy Performance	DP151KS02-CAM-S	FDA UDI	Class I	Active
Donjoy	11-0677-9-00000	FDA UDI	Class II	Active
Djo Surgical	801-01-540	FDA UDI	Class I	Active
Donjoy	11-1334-9-00000	FDA UDI	Class II	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).