CLASS II Device recall · Reported 4 Apr 2018 · FDA Enforcement Report
Coach¿ Self-Adhering Sports Wrap (size recalled
Johnson & Johnson Consumer is recalling Coach¿ Self-Adhering Sports 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
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-1201-2018
- 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
COACH¿ Self-Adhering Sports Wrap (size: 2in)
Where it was distributed
Nationally
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
100497502 381370079286 3813700497530024
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 79454| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Johnson & Johnson Band-aid¿ First Aid Products recalled | Johnson & Johnson Consumer | Foreign Material | Nationwide | |
| CLASS II | Johnson & Johnson Band-aid¿ First Aid Products Hurt-free¿ recalled | Johnson & Johnson Consumer | Foreign Material | Nationwide | |
| CLASS II | Johnson & Johnson Band-aid¿ First Aid Products Hurt-free¿ recalled | Johnson & Johnson Consumer | Foreign Material | Nationwide | |
| CLASS II | Coach¿ Self-Adhering Sports Wrap (size recalled | Johnson & Johnson Consumer | Foreign Material | Nationwide | |
| CLASS II | Johnson & Johnson Band-aid¿ First Aid Products recalled | Johnson & Johnson Consumer | Foreign Material | Nationwide |
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