FDA Medical devices recall ·
MEGA 7.5Fr recall
- Recall number
- Z-0311-2025
- Date
- (initiated September 17, 2024)
- Company / brand
- Datascope Corp.
15 Law Dr Unit 1, Fairfield, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 160 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01
Why was it recalled?
There is discrepant labeling on the inner and outer packaging of the device.
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
UDI-DI: 10607567107974; Lot Number: 3000344298
Distribution
International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.
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-0311-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.