Class II — Merit Medical Systems, Inc.
| Recalling firm | Merit Medical Systems, Inc. |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 1,445 |
| Distribution | Worldwide Distribution - US including TN, NE, MA, SC, WI, UT and Internationally to Belgium, Switzerland, United Kingdom, and Germany. |
| Initiated | 2015-06-04 |
| Classified | 2015-06-22 |
| Terminated | 2015-10-26 |
| Recall number | Z-1826-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Merit Medical Systems, Inc. (Z-1826-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71519/
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