This is an accessory to Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices
Medical device recall Z-2590-2020. Published in FDA’s Enforcement Report on Jul 22, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jul 22, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 41 states named
- 41,801 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The device accessories were not labeled with appropriate latex warning.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
41,801 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,996 characters
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…
FDA’s list runs to 2,217 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
41 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Virginia
- Washington
- Wisconsin
- West Virginia
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jun 25, 2018.
- FDA classified it on Jul 13, 2020.
- FDA’s Enforcement Report published it on Jul 22, 2020.
- FDA terminated it on Nov 15, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- DJO, LLC, of Vista, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,217 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.