Recall archive / FDA device enforcement
Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D — FDA record Z-1434-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 27, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Prelude IDEAL 4 F Hydrophilic Sheath Introducer, REF: PID4F16021PW/D
- Reason
- Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Incorrect dilator use may result in procedure delay.
- Classification
- Class II
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 40
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1434-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00884450693919. Lot: H3082668. Expiration: 14-Nov-24 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution to the country of Japan.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Apr 2, 2025
- Recall initiation date
- Jan 27, 2025
- Center classification date
- Mar 24, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.