FDA Device recall Z-1270-2022
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
- FDA Device
- Class II
- terminated
- Published 2022-06-22
On 2022-06-22 the FDA classified a Class II recall of Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 by Volcano, citing due to a potential failed sterilization process.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1270-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-05-16 |
| Published | 2022-06-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Volcano |
| Distribution | WA, WI |
Product
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Reason
Due to a potential failed sterilization process.
Identifiers
| code_info | Model Number: 89185J Part Number: 300000252891 UDI Code: (01)00845225003050(11)220309(17)250309(10)0302535768 Serial Nu…Model Number: 89185J Part Number: 300000252891 UDI Code: (01)00845225003050(11)220309(17)250309(10)0302535768 Serial Numbers: 37583 37586 37590 37598 37612 37648 37655 37692 37694 37709 37719 |
|---|
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-1270-2022%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.