Merit Medical Prelude Pro Sheath Introducter — Class II medical device recall Z-1826-2015
Terminated recall by Merit Medical Systems, Inc., reported 2015-07-01, distributed in MA, NE, SC, TN, UT, WI. Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch.
| Recall number | Z-1826-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2015-06-04 |
| Classified | 2015-06-22 |
| Reported by FDA | 2015-07-01 |
| Terminated | 2015-10-26 |
| Distributed | MA, NE, SC, TN, UT, WI |
| Countries outside the US | BE, CH, DE, GB |
| Quantity | 1,445 |
| Reason classes | labeling |
| Lot numbers | H767887 |
| Model numbers | PR0-6F-11-038, PRO-6F-11-038 |
Product
Merit Medical Prelude Pro Sheath Introducter, 6F (2.0mm) 11cm, REF PRO-6F-11-038, Sterile EO The Merit Prelude Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Reason for recall
Some of these introducer sheaths were packaged with a 0.035 inch dilator, rather than the labeled 0.038 inch. This affects one lot, H767887, of catalog number PR0-6F-11-038.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1826-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.