Lower risk Medical device recall · FDA · Published May 16, 2022

Philips OmniWire Pressure Guide Wire Recall: Failed Sterilization Risk

Volcano Corp recalls Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 due to potential failed sterilization. Affected units have specific serial numbers and part numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1270-2022Medical device Volcano Corp ›

Lower-risk recall

Due to a potential failed sterilization process.

Take action

Contact the company

Recalling firmVolcano Corp3721 Valley Centre Dr Ste 500 · San Diego, CA 92130-3328

✎ GovInfoNow plain-language explainer

Volcano Corp has recalled Philips OmniWire Pressure guide wire model 89185J with part number 300000252891 because of a potential failed sterilization process. This could lead to contamination risks during medical procedures. Read more at govinfonow.com/recall/60700-philips-omniwire-pressure-guide-wire-recall-failed-sterilization-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/60700-philips-omniwire-pressure-guide-wire-recall-failed-sterilization-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1270-2022

Cite this page

“Philips OmniWire Pressure Guide Wire Recall: Failed Sterilization Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/60700-philips-omniwire-pressure-guide-wire-recall-failed-sterilization-risk. Based on FDA recall #Z-1270-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1270-2022%22&limit=1).

The Food and Drug Administration announced on May 16, 2022, that Volcano Corp is recalling Philips OmniWire Pressure guide wires due to a potential failed sterilization process. Owners should contact the manufacturer for remedy details.

How to tell if you have it

Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
UPC: 00845225003050
Serial Numbers: 37583, 37586, 37590, 37598, 37612, 37648, 37655, 37692, 37694, 37709, 37719

The hazard

The recall is due to a potential failed sterilization process for the Philips OmniWire Pressure guide wire.

Context

GovInfoNow's records show Volcano Corp has had five other recalls on record since Jan. 24, 2022. Other recent recalls of similar products include Philips IntraSight Plus Software Error (Aug. 6, 2026), Volcano Visions Digital IVUS Catheter Recall (June 13, 2025), and Volcano Visions PV.035 Digital IVUS Catheter Recall (May 13, 2022). Other recent recalls of similar products include Merit Medical Splashwire Hydrophilic Guide Wire Recall (May 8, 2026), Olympus OER-ELITE Endoscope Reprocessor Connecting Tubes Recall (March 25, 2026), and Medline Convenience Kits Recall (Jan. 7, 2026).

How to tell if you have this one

Check for serial numbers 37583, 37586, 37590, 37598, 37612, 37648, 37655, 37692, 37694, 37709, or 37719. The product has a specific part number 300000252891 and model number 89185J.

Brand
Volcano Corp
Product
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Serial Numbers
Look for serial numbers 37583, 37586, 37590, 37598, 37612, 37648, 37655, 37692, 37694, 37709, or 37719 on the device.

Where it went and when

Where it was distributed

Distributed in Washington and Wisconsin, and outside the U.S.

FDA distribution: “U.S.: WA and WI O.U.S.: Canada” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Washington, Wisconsin.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

May 16, 2022Firm started the recall
Jun 16, 2022FDA classified it Class II
Jun 22, 2022Published in FDA’s Enforcement Report
Dec 23, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/60700-philips-omniwire-pressure-guide-wire-recall-failed-sterilization-risk">Philips OmniWire Pressure Guide Wire Recall: Failed Sterilization Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1270-2022 (May 16, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1270-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.