RegWardenFDA facility compliance records
Recall

Class II — Stryker, Inc.

Recalling firmSTRYKER CORP.
Registered facilityView this company's 61 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonThe microcatheter IFU contains an intended use that has not been evaluated by the FDA.
ProductStryker Neurovascular, Trevo Trak 21 Microcatheter, REF 90338, 0.021in X162cm
Quantity63 units
DistributionUS Nationwide distribution in the states of AL, FL, GA, HI, IL, MI, NC, NH, OH, PA, TX, VA.
Initiated2023-12-06
Classified2024-02-14
Recall numberZ-1085-2024
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Stryker, Inc. (Z-1085-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93678/

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