CLASS III Device recall · Reported 20 Jul 2016 · FDA Enforcement Report
Breathe Right recalled by GSK Consumer Healthcare
GSK Consumer Healthcare is recalling Breathe Right, distributed nationwide in the US. The recall was initiated on 25 Apr 2016 and the FDA has classified it as Class III.
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-2148-2016
- FDA event ID
- 74030
- Recalling firm
- GSK Consumer Healthcare, Warren, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Apr 2016
- FDA classified
- 11 Jul 2016
- Reported
- 20 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 25 Apr 2016 | Recall initiated by company | |
| 11 Jul 2016 | Classified by FDA | +77 days |
| 20 Jul 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips were incorrectly labeled for cartons intended for the AU/NZ market.
Product as listed by the FDA
Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
Where it was distributed
US Nationwide
Questions about this recall
Why was it recalled?
Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips were incorrectly labeled for cartons intended for the AU/NZ market.
Which lots are affected?
Shipper case lot #8008580, Retal Carton Lot #4543U8008580
Where was it sold?
US Nationwide
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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