# FDA recall Z-1270-2022

> **Volcano Corp** · Class II · device recall initiated 2022-05-16.

## Product

Philips OmniWire Pressure guide wire REF 89185J PN 300000252891

## Reason for recall

Due to a potential failed sterilization process.

## Distribution

U.S.: WA and WI  O.U.S.: Canada

## Key facts

- **Recall number:** Z-1270-2022
- **Recalling firm:** Volcano Corp
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-05-16
- **Report date:** 2022-06-22
- **Termination date:** 2024-12-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1270-2022

## Citation

> AI Analytics. FDA recall Z-1270-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1270-2022. Source: US FDA. Licensed CC0.

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