Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 — Class II medical device recall Z-1270-2022
Terminated recall by Volcano Corp, reported 2022-06-22, distributed in WA, WI. Due to a potential failed sterilization process.
| Recall number | Z-1270-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Volcano Corp, San Diego, CA, United States |
| Recall initiated | 2022-05-16 |
| Classified | 2022-06-16 |
| Reported by FDA | 2022-06-22 |
| Terminated | 2024-12-23 |
| Distributed | WA, WI |
| Countries outside the US | CA |
| Quantity | 11 devices |
| UPC / GTIN / UDI-DI | 00845225003050 |
| Serial numbers | 37583, 37586, 37590, 37598, 37612, 37648, 37655, 37692, 37694, 37709, 37719 |
| Model numbers | 300000252891, 89185J, 89185JPN |
Product
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Reason for recall
Due to a potential failed sterilization process.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1270-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.