CLASS II Device recall · Reported 22 Jul 2020 · FDA Enforcement Report
This is an accessory to Intelect Advanced, Intelect Mobile recalled
DJO is recalling This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic, distributed nationwide in the US. The recall was initiated on 25 Jun 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2590-2020
- FDA event ID
- 85445
- Recalling firm
- DJO, Vista, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jun 2018
- FDA classified
- 13 Jul 2020
- Reported
- 22 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 25 Jun 2018 | Recall initiated by company | |
| 13 Jul 2020 | Classified by FDA | +749 days |
| 22 Jul 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device accessories were not labeled with appropriate latex warning.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and WV The countries of Algeria, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Congo, Congo, The Democratic Republic of the, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, England, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea, Republic of, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, United Republic of, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Viet Nam.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMichiganMinnesota
Questions about this recall
Why was it recalled?
The device accessories were not labeled with appropriate latex warning.
Which lots are affected?
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 APPL 2777/ INTELECT MOBILE 2CH STIMINT'L STD 2778/ INTELECT MOBILE COMBO, INT'L STD, 5CM APPL 2778-2/ INTELECT MOBILE COMBO, INT'L STD, 2CM APPL 5951/ INTELECT VITALSTIM 2 CHANNEL THERAPY SYSTEM, INT'L STD 2752CC/ INT ADV 2CH COLOR COMBO INT'L STD 2762CC/ INT ADV 2CH COLOR COMBO, INT'L 5CM APPL 2772MC/ INT ADVANCED COMBO MONOCHROMEINT'L STD 2755CS/ INT ADV 2CH COLOR STIM INT'L STD 2762CC-2/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD, 2CM APPL 2765CS/ INT ADV 2CH COLOR STIM W/EMG INTL STD 2773MS/ INT ADVANCED STIM MONOCHROME INT'L STD 2762CC-10/ INT ADV 2CH COLOR COMBO W/O EM INT'L STD, 10CM APPL 2770/ STIM MODULE CH 3/4 INT'L PKG 3102/ C-5 120V PKG A 3114/ C-5 220V PKG A INT'L STD 1200/ NYLATEX INTRO PACK 1202/ NYLATEX 2-1/2X18 BAG OF 3* 1204/ NYLATEX 2-1/2X36 BAG OF 3* 1206/ NYLATEX 2-1/2X48 BAG OF 3* 1208/ NYLATEX 4X18 BAG OF 3* 1210/ NYLATEX 4X36 BAG OF 3* 1212/ NYLATEX 4X48 BAG OF 3* 1213/ NYLATEX 4X60 BAG OF 3* 1214/ NYLATEX 6X18 BAG OF 3* 1216/ NYLATEX 6X36 BAG OF 3* 1218/ NYLATEX 6X48 BAG OF 3* 1219/ NYLATEX 6X60 BAG OF 3 1264/ NYLATEX 2-1/2X24 BAG OF 3* 10648/ NYLATEX 2-1/2X24 SEWN 28099/ KIT, LEAD IN MOBILE STIM INTL 59048/ KIT LEAD STIM INT CLINIC VITLS (CH 1/2) 27378/ KIT LEAD INT ADVANCED 2CH 27509/ KIT LED 4CH EPR INT L
Where was it sold?
Worldwide distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI and WV The countries of Algeria, Armenia, Australia, Austria, Azerbaijan, Bahamas, Bahrain, Belgium, Bolivia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Congo, Congo, The Democratic Republic of the, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, England, Estonia, Ethiopia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Korea, Republic of, Kuwait, Lebanon, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, United Republic of, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Viet Nam.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from DJO
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Donjoy Iceman, W/coldpad, Ns, Rh recalled by DJO | DJO | Device Malfunction | Nationwide |
| Device | CLASS II | Donjoy Iceman W/,univ,loop,ns,rh recalled by DJO | DJO | Device Malfunction | Nationwide |
| Device | CLASS II | Donjoy Iceman Classic Cube recalled by DJO | DJO | Device Malfunction | Nationwide |
| Device | CLASS II | Donjoy Iceman W/,univ,loop,ns,eh recalled by DJO | DJO | Device Malfunction | Nationwide |
| Device | CLASS II | Cold Form Wrap: Back recalled by DJO | DJO | Packaging Defects | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |