DJO, LLC
FDA Regulatory Profile
DJO, LLC appears in FDA public data with 11 recalls — including 2 Class I (most serious) —, 12 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2136-2026, Class II) was initiated on March 19, 2026. Its most recent 510(k) clearance was granted on November 27, 2020.
Summary
- Total Recalls
- 11 (2 Class I)
- 510(k) Clearances
- 12
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2136-2026 | Class II | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software | March 19, 2026 |
| Z-2137-2026 | Class II | Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software | March 19, 2026 |
| Z-2135-2026 | Class II | Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software | March 19, 2026 |
| Z-2134-2026 | Class II | Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog Number: 11-0494 Software Versi | March 19, 2026 |
| Z-0722-2026 | Class II | Cold Form Wrap: Back, REF: DP163CT03-BLK-L,XL, and Shoulder, REF: DP163CT02 | September 25, 2025 |
| Z-0009-2022 | Class I | GEL CONDUCTOR, Description/REF: 5 LITER W/DISP/4238, 24-8.5OZ BOTTLES/4248, 5 LITER/4266, distribute | September 7, 2021 |
| Z-0010-2022 | Class I | Ultra-Myossage Lotion 1-gallon bottle, REF: 4262; Myossage Lotion 1-gallon bottle, REF: 4210, locat | September 7, 2021 |
| Z-1985-2019 | Class II | Aircast REF 3011 - PL RX only VF-PL Sterile Cuff Pkg., Lot# 418003, Expiration Date: 2020 -12 - 31, | January 17, 2019 |
| Z-2590-2020 | Class II | This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. NYLAT | June 25, 2018 |
| Z-0121-2016 | Class II | Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Di | August 21, 2015 |
| Z-1661-2013 | Class II | VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System is a compression pump | May 28, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K201653 | Compex Sport Elite 3.0 | November 27, 2020 |
| K170918 | Compex Sport Elite | June 20, 2017 |
| K170903 | Compex Wireless USA | June 19, 2017 |
| K153704 | Strive | June 3, 2016 |
| K153696 | Chattanooga Revolution Wireless | April 14, 2016 |
| K153224 | VitalStim(R) Plus Electrotherapy System | February 17, 2016 |
| K143551 | Compex Wireless USA | April 28, 2015 |
| K132284 | VECTRA NEO CLINICAL THERAPY SYSTEM | April 10, 2014 |
| K130722 | AIRCAST VENAFLOW ELITE SYSTEM | June 20, 2013 |
| K124016 | EMPI PHOENIX | May 6, 2013 |
| K122499 | AIRCAST VENAFLOW ELITE SYSTEM | October 18, 2012 |
| K091700 | AIRCAST VENAFLOW ELITE SYSTEM | July 9, 2009 |