Volcano Corp Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
Brand
Volcano Corp
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Volcano Corp is recalling Philips OmniWire Pressure guide wire REF 89185J PN 300000252891 due to Due to a potential failed sterilization process.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Due to a potential failed sterilization process.
Recommended Action
Per FDA guidance
On May 16, 2022, Philips sent an "URGENT Medical Device Recall" Letter via email to Philips Sales Representatives who then delivered directly to the affected customer. The Letter informed customers that between 05/04-12/2022, potentially non-sterile products were shipped to customers. Customer are asked to immediately check their product inventory and quarantine any affected products to prevent use. Affected product is requested to be returned to Philips IGTD for replacement products. To acknowledge receipt of this notification, please complete, sign, and return the Customer Reply Form within 30 days upon receipt of this notice to Email: igtdc.r@philips.com For further information or support concerning this issue, contact the local Philips representative: Philips IGTD Customer Service: Phone: 1-800-722-9377, Option 1 Email: IGTD.CustomerInquiry@philips.com Hours of Operation: Monday - Friday 8:00AM 5:00PM PST
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
WA, WI
Page updated: Jan 10, 2026