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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90292

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 16, 2022
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Volcano Corp

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Philips OmniWire Pressure guide wire REF 89185J PN 300000252891

Z-1270-2022
Recall number
Z-1270-2022
Initiated
May 16, 2022
Classification
Class II
Status
Terminated
Recalling firm
Volcano Corp
Quantity
11 devices

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
failed sterilization

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to a potential failed sterilization process.

Code information

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

Distribution pattern

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