FDA Medical devices recall ·
Prelude IDEAL 4 F Hydrophilic Sheath Introducer recall
- Recall number
- Z-1434-2025
- Date
- (initiated January 27, 2025)
- Company / brand
- Merit Medical Systems, Inc.
1600 W Merit Pkwy, South Jordan, UT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 40
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
Why was it recalled?
Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
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: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24
Distribution
International distribution to the country of Japan.
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-1434-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.