The Recall Desk
ModerateFDA (Devices)·Z-1204-2018·Announced 2018-04-04

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

Johnson & Johnson is voluntarily recalling select first aid wraps because the label 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 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 specific products, including the 3-inch SECURE-FLEX Wrap, which were distributed nationally.

The recall is being conducted because the current labeling claims the products are "not made with natural rubber latex." Recent awareness indicates 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 should check their first aid supplies for these specific products and the associated lot codes. If they possess the recalled items, they should stop using them and follow the instructions provided by the recalling firm or retailer for returns or replacements.

The recalled product

Product
Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ Wrap (size: 3in)
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)

  • 111615100 381371161515 103813711615120000

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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