FDA Medical devices recall ·
medex TranStar Single OR Set 1/EA, Product Code recall
- Recall number
- Z-0182-2025
- Date
- (initiated September 24, 2024)
- Company / brand
- Smiths Medical ASD, Inc.
6000 Nathan Ln N, Minneapolis, MN, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 260 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2
Why was it recalled?
Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.
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 50351688508780 (case), 10351688508782 (pouch) , Lot Numbers: 4282732, 4287721
Distribution
Worldwide distribution.
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-0182-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.