DeviceSignal · Recall classified

Stryker Corporation

FDA classified a device recall on 2026-08-03 · Class II · Z-2866-2026

EventRecall classified
Effective2026-08-03
ClassificationClass II

On 2026-08-03 the FDA classified a device recall from Stryker Corporation as Class II. Product: STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540. Recall Z-2866-2026. The firm initiated it on 2026-06-08. This reports the classification FDA published on that date.

Reported facts

Recall number
Z-2866-2026
Classification
Class II
Classified on
2026-08-03
Initiated on
2026-06-08
Firm
Stryker Corporation
Reason
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Product
STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540

Every field above is as fda_device_enforcement published it. Nothing on this page is our interpretation.

Provenance

Source
fda_device_enforcement
Source record
Z-2866-2026
Snapshot hash
ab5ada73bf212eb52a548aab0968a0fcee42807c61b0350e60e24bb6e2beed72
Source URL
https://download.open.fda.gov/device/enforcement/device-enforcement-0001-of-0001.json.zip
Observed
2026-09-08T16:22:09.483Z
Transform
fda_device_enforcement_to_recall v1
Event rule
fda_device_recall_classified v1
Event key
413c6480ef00dc625262ff68127849108605ff6d2831761d448f43b2a0fcb13f
Signal type
device_recall.classified

Source terms that apply

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Data provided by the U.S. Food and Drug Administration (https://open.fda.gov)