FDA Device recall Z-1916-2023
Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2023-06-21
On 2023-06-21 the FDA classified a Class II recall of Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only by Merit Medical Systems, citing there is a potential that valve assemblies will not open. preventing fluid from draining.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1916-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-04-22 |
| Published | 2023-06-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
Reason
There is a potential that valve assemblies will not open. preventing fluid from draining.
Identifiers
| code_info | Lot # I2604364, I2604393, I2587036, I2564649, I2558681, I2604394, I2609065, I2623156, I2577984; UDI-DI: 00884450394960 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1916-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.