FDA Device recall Z-2590-2020
This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices
- FDA Device
- Class II
- terminated
- Published 2020-07-22
On 2020-07-22 the FDA classified a Class II recall of This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices by Djo, citing the device accessories were not labeled with appropriate latex warning.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2590-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-25 |
| Published | 2020-07-22 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Djo |
| Distribution | US |
Product
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 patient.
Reason
The device accessories were not labeled with appropriate latex warning.
Identifiers
| code_info | Part Number/ Description: 10679/ NYLATEX 4X36 PKG SING FOR UNIT 10827/ NYLATEX 2-1/2 X 18 CUT 10828/ NYLATEX 2-1/2X1…Part Number/ Description: 10679/ NYLATEX 4X36 PKG SING FOR UNIT 10827/ NYLATEX 2-1/2 X 18 CUT 10828/ NYLATEX 2-1/2X18 SEWN 10829/ NYLATEX 2-1/2X36 CUT 10830/ NYLATEX 2-1/2X36 SEWN 10831/ NYLATEX 2-1/2X48 CUT 10832/ NYLATEX 2-1/2X48 SEWN 10833/ NYLATEX 4X18 CUT 10834/ NYLATEX 4X18 SEWN 10835/ NYLATEX 4X36 CUT 10836/ NYLATEX 4X36 SEWN 10837/ NYLATEX 4X48 CUT 10838/ NYLATEX 4X48 SEWN 10839/ NYLATEX 6X18 CUT 10840/ NYLATEX 6X18 SEWN 10841/ NYLATEX 6X36 CUT 10842/ NYLATEX 6X36 SEWN 10843/ NYLATEX 6X48 CUT 10844/ NYLATEX 6X48 SEWN 12-0248-8/ NYLATEX 2-1/2X24 CUT 1210CHT/ NYLATEX 4X36 BAG OF 3 1214CHT/ NYLATEX 6X18 BAG OF 3 1213CHT/ NYLATEX 4X60 BAG OF 3 19991/ NYLATEX 6X60 CUT 19992 /NYLATEX 6X60 SEWN 19993/ NYLATEX 4X60 CUT 19994/ NYLATEX 4X60 SEWN 25-10648/ NYLATEX 2-1/2X24 25-10679/ NYLATEX 4X36 12-10648/ NYLATEX 2-1/2 X 24 SEWN 12-8655/ ASSY,STIM MODULE CH 3/4 INT'L PKG 3448274/ C-5 220-240V OEM ENRAF W/PKS 2778-10/ INTELECT MOBILE COMBO, INT'L STD, 10CM |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2590-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.