Breathe Right Clear — Class III medical device recall Z-2148-2016
Terminated recall by GSK Consumer Healthcare, reported 2016-07-20, distributed nationwide. Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips were incorrect
| Recall number | Z-2148-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GSK Consumer Healthcare, Warren, NJ, United States |
| Recall initiated | 2016-04-25 |
| Classified | 2016-07-11 |
| Reported by FDA | 2016-07-20 |
| Terminated | 2017-07-19 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00757145002467 |
| Lot numbers | 4543U8008580, 8008580 |
Product
Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2148-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.