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 | There is a potential that 7F sheaths are packaged as 10F sheaths. |
| Product | Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system. |
| Quantity | 760 units |
| Distribution | US:AL,AR,CA,CO,DE,FL,GA,HI,IA,IL,KY,MA,MD,ME,MI,MN,NC,NE,NJ,NV,NY,OH,OR,PA,RI,TX,VA,VT, WI OUS: Norway |
| Initiated | 2021-06-30 |
| Classified | 2021-08-10 |
| Terminated | 2023-02-24 |
| Recall number | Z-2238-2021 |
| 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-2238-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88315/
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