DJO, LLC

FDA recalling firm · 7 enforcement events · 11 product records · 2013–2026 · CA

DJO, LLC has 7 FDA enforcement events on this register (11 product records) between 2013 and 2026: 7 device; the busiest year was 2013 with 1.

14% of its events are Class I; the most common class is Class II (6). 4 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
19 Mar 2026	Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Version: no Product Description: 11-0494 - ICEMAN CLASSIC CUBE The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMan¿ helps provide extended cold therapy to aid in a…	Device	Class II	4	Ongoing
25 Sep 2025	Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02	Device	Class II	1	Ongoing
7 Sep 2021	GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distributed by DJO, LLC / DJO FRANCE in the following kits, Part/Description: 2073/ INTELECT RPW 120V, 2073-BR/ INTELECT RPW 120V BRAZIL, 2074/ INTELECT RPW 230 V, 2082/ INTELECT RPW 100 V, 2760/ INTELECT LEGEND XT COMBOUS STD,…	Device	Class I	2	Ongoing
17 Jan 2019	Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, Made in Mexico, DJO, LLC.	Device	Class II	1	Ongoing
25 Jun 2018	This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLATEX WRAP - Product Usage: are intended to be used based on the devices associated with them. Nylatex wraps are composed of nylon and natural rubber and are accessories used to secure electrodes or thermal therapy to a…	Device	Class II	1	Terminated
21 Aug 2015	Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.	Device	Class II	1	Terminated
28 May 2013	VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump used for the prevention of Deep Vein Thrombosis.	Device	Class II	1	Terminated

By type and class

Device7

Class II6

Class I1

Class I: 14% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for DJO, LLC by year initiated.

Questions and answers

How many FDA recalls has DJO, LLC had?

7 enforcement events (11 product records) on this register, 2013–2026: 7 device.

Are any DJO, LLC recalls ongoing?

4 events are listed as ongoing in the current openFDA export.

What class are DJO, LLC recalls?

6 Class II, 1 Class I. 14% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.