FDA Medical devices recall ·
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK… recall
- Recall number
- Z-1724-2025
- Date
- (initiated April 4, 2025)
- Company / brand
- Integra LifeSciences Corp. (NeuroSciences)
1100 Campus Rd, Princeton, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 6 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter.
Why was it recalled?
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. BC1040AZ; UDI: 20705031063157; Lot No. 240716A-PC.
Distribution
US Nationwide distribution in the states of TX, MT, AL & OK.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1724-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.