FDA Device recall Z-0458-2022
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile
- FDA Device
- Class II
- terminated
- Published 2022-01-12
On 2022-01-12 the FDA classified a Class II recall of UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile by Uromedica, citing the U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0458-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-11-22 |
| Published | 2022-01-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Uromedica |
| Distribution | US |
Product
UROMEDICA Implantation Instrument Set (Sheath and Sharp Trocar), REF 750041, nonsterile.
Reason
The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.
Identifiers
| code_info | Lot numbers UM00794 and UM00817, UDI 00180668000106 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0458-2022%22
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