FDA Medical Device Recalls (openFDA)
Volcano Corp: Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
- Recall number
- Z-1270-2022
- Recalling firm
- Volcano Corp
- Product
- Philips OmniWire Pressure guide wire REF 89185J PN 300000252891
- Status
- Terminated
- Initiated
- 2022-05-16
- Posted
- not on file
- Terminated
- 2024-12-23
- Reason
- Due to a potential failed sterilization process.
- Root cause
- Under Investigation by firm
- Action
- 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
- Quantity
- 11 devices
- Distribution
- U.S.: WA and WI O.U.S.: Canada
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K202543"]
- PMA numbers
- not on file
- Product code
- DXQ
- Firm FEI
- 3008363989
- Firm city
- San Diego
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28