The Recall Desk
ModerateFDA (Devices)·Z-1203-2018·Announced 2018-04-04

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

Johnson & Johnson is recalling select first aid wraps because they were labeled as latex-free but used natural latex in early manufacturing.

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 latex content. Per the rubric, minor labeling errors and voluntary precautionary recalls fall under the Moderate severity category.

Plain-English summary

Johnson & Johnson Consumer, Inc. is conducting a voluntary Class II recall 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 being initiated at the retail level in the United States.

The products are being recalled because the current labeling states they are "not made with natural rubber latex." However, the company recently became aware that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex. The labeling needs to be updated to reflect this information.

Consumers with these products should check the packaging for the specific product names and codes listed in the official recall notice. If the product matches the description, consumers should stop using it and contact Johnson & Johnson for further instructions or a refund.

The recalled product

Product
Johnson & Johnson BAND-AID¿ Brand First Aid Products SECURE-FLEX¿ 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)

  • 111615000 381371161508 103813711615050000

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.

See all →

Same hazard · latex allergy

See all →