FDAApril 4, 2025device
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
What to do
FDA enforcement status: Ongoing
Brands named
integra lifesciences corp neurosciencesintegraintegra lifesciences
UPCs
20705031063157
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDAEdwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO2026-03-27
- FDACytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505.2026-03-19
- FDACytal Burn Matrix 7x10 cm. Product ID: BMM0710.2026-03-19
- FDACytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015.2026-03-19
- FDACytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.2026-03-19
- FDACytal Burn Matrix 10x15 cm. Product ID: BMM1015.2026-03-19
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