CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report

Johnson & Johnson Band-aid¿ First Aid Products Hurt-free¿ recalled

Johnson & Johnson Consumer is recalling Johnson & Johnson Band-aid¿ First Aid Products Hurt-free¿ Wrap (size, distributed nationwide in the US. The recall was initiated on 18 Dec 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes111614600 381371161461 103813711614680000

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1206-2018
FDA event ID: 79454
Recalling firm: Johnson & Johnson Consumer, Skillman, NJ
Classification: Class II
Status: Terminated
Recall initiated: 18 Dec 2017
FDA classified: 27 Mar 2018
Reported: 4 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

18 Dec 2017	Recall initiated by company
27 Mar 2018	Classified by FDA	+99 days
4 Apr 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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 products. The current labeling claim states not made with natural rubber latex which needs to be updated based upon recent awareness that natural latex was used as a base ingredient in the early-stage manufacturing process, which reduces the allergic protein found in natural latex.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Johnson & Johnson BAND-AID¿ Brand First Aid Products HURT-FREE¿ Wrap (size: 2in)

Where it was distributed

Nationally

Nationwide

Questions about this recall

Is Johnson & Johnson Band-aid¿ First Aid Products Hurt-free¿ Wrap (size recalled?

Yes. Johnson & Johnson Consumer recalled Johnson & Johnson Band-aid¿ First Aid Products Hurt-free¿ Wrap (size on 18 Dec 2017. The recall is Class II and its status is Terminated. Recall number Z-1206-2018.

Why was it recalled?

Which lots are affected?

111614600 381371161461 103813711614680000

Where was it sold?

Nationally

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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