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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93678

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 06, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Stryker, Inc.

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

2 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 2

Stryker Neurovascular, Trevo Pro 18 Microcatheter, REF 90238 0.021in X150cm

Z-1084-2024
Recall number
Z-1084-2024
Initiated
December 06, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Stryker, Inc.
Quantity
11 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

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

The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

Code information

UDI: (01)00815742002386/Lot Number(s): 0000228865 0000370674

Distribution pattern

US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.

device · product 2 of 2

Stryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm

Z-1085-2024
Recall number
Z-1085-2024
Initiated
December 06, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Stryker, Inc.
Quantity
63 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

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

The microcatheter IFU contains an intended use that has not been evaluated by the FDA.

Code information

UDI: (01)07613327313956/Lot Number(s): 0000136913 0000144331, 0000163582, 0000164440, 0000182275, 0000230955, 0000240597, 0000244845, 0000370674

Distribution pattern

US Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.