The Recall Desk
ModerateFDA (Devices)·Z-1205-2018·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 'not made with natural rubber latex' label is inaccurate.

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 a common allergen (latex). Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries 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 U.S. of 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 1-inch size of the HURT-FREE Wrap, as indicated by the product metadata.

The reason for the recall is a labeling error. The current product labeling states that the items are 'not made with natural rubber latex.' However, the manufacturer has recently become 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 existing label claim is inaccurate and needs to be updated.

Consumers who have purchased these specific products should check their packaging for the 'not made with natural rubber latex' claim. Individuals with a known latex allergy should exercise caution when using these products and consult a healthcare provider if they experience any allergic reactions. The recall is voluntary and is being conducted at the retail level.

The recalled product

Product
Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 1in)
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)

  • 111614500 381371161454 10381371161451

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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