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 | 4 lots of Performa Cardiac Multipacks contain a JR4.0 catheter with a slight variation in tip shape. |
| Product | Merit Medical Performa Angiographic Catheter 5F Multipack. Part numbers 7560-43 and 7560-G3. |
| Quantity | 200 |
| Distribution | US Distribution including the states of CO, VA, and MS. |
| Initiated | 2013-09-13 |
| Classified | 2013-10-22 |
| Terminated | 2014-01-03 |
| Recall number | Z-0045-2014 |
| 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-0045-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66400/
Alerts for Merit Medical Systems, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.