The Recall Desk
ModerateFDA (Devices)·Z-1206-2018·Announced 2018-04-04

Johnson & Johnson Recalls First Aid Wraps Due to Latex Labeling Error

Johnson & Johnson is voluntarily recalling select first aid wraps because the packaging incorrectly states they are not made with natural rubber latex.

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 involves a labeling error regarding natural rubber latex. Per the rubric, minor labeling errors and voluntary precautionary recalls fall under the Moderate severity category.

Plain-English summary

Johnson & Johnson Consumer, Inc. is initiating a voluntary Class II recall at the retail level in the United States for select COACH Self-Adhering Sports Wraps, BAND-AID Brand First Aid Products SECURE-FLEX Wraps, and BAND-AID Brand First Aid Products HURT-FREE Wraps. The recall is limited to the 2-inch size of the HURT-FREE Wrap, specifically identified by the code 111614600 381371161461 103813711614680000.

The reason for the recall is a labeling discrepancy. The current product labeling claims the items are "not made with natural rubber latex." However, the manufacturer recently became aware that natural latex was used as a base ingredient in the early-stage manufacturing process, although this process reduces the allergic protein found in natural latex. The labeling needs to be updated to reflect this fact.

Consumers with these specific products should check the packaging for the incorrect latex claim. The source text does not specify a required consumer action such as returning the product or stopping use, but the recall is classified as Class II, indicating the product could temporarily cause or contribute to reversible adverse health consequences.

The recalled product

Product
Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in)
Manufacturer
Johnson & Johnson Consumer, Inc.
Category
Medical Device — First Aid / Wound Care
Hazard

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 (1)

  • 111614600 381371161461 103813711614680000

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 6 recalled by Johnson & Johnson Consumer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Related recalls

Same manufacturer · Johnson & Johnson Consumer, Inc.

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Same hazard · latex allergy

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