DJO Nylatex Wraps Recalled for Missing Latex Warning Labels
DJO, LLC is recalling Nylatex wraps used with Intelect and V-Sonic devices because they lack appropriate latex warning labels.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a labeling error (missing latex warning) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
DJO, LLC is recalling Nylatex wraps, which are accessories used to secure electrodes or thermal therapy to patients on Intelect Advanced, Intelect Mobile, Intelect Neo, and V-Sonic devices. The recall involves 41,801 units that were distributed worldwide, including nationwide in the United States and in numerous international countries.
The recall was initiated because the device accessories were not labeled with appropriate latex warnings. Nylatex wraps are composed of nylon and natural rubber, which may pose a risk to patients with latex allergies if the warning is not present.
Consumers and healthcare providers should stop using the affected Nylatex wraps and contact DJO, LLC for further instructions or a replacement. The specific part numbers and product codes for the affected units are listed in the official recall documentation.
The recalled product
- 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 secur
- Manufacturer
- DJO, LLC
- Affected units
- 41,801
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- INT'L STD
- 10CM APPL 2777/ INTELECT MOBILE 2CH STIMINT'L STD 2778/ INTELECT MOBILE COMBO
- 5CM APPL 2778-2/ INTELECT MOBILE COMBO
- 2CM APPL 5951/ INTELECT VITALSTIM 2 CHANNEL THERAPY SYSTEM
Distribution
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