Recall Ledger

STRYKER PKG. recall (Stryker Corporation)

Medical deviceClass IIOngoing

Summary: Stryker Corporation is recalling STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540. Reason: There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

What is being recalled

STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540

Why

There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Worldwide distribution - US Nationwide and the countries of Australia, Brazil, Canada, Chile, France, Germany, Indonesia, Italy, Mexico, Netherlands, New Zealand, Philippines, South Korea, Spain, Sweden, Switzerland, Taiwan, United Kingdom.

How to tell if yours is affected

GTIN 0761332706146, Batch Numbers: 24297FG2, 24306FG2, 24344FG2, 25007FG2, 25065FG2, 25091FG2, 25168FG2.

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-2866-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJune 8, 2026
ReportedAugust 12, 2026
CompanyStryker Corporation
Company locationSan Jose, CA, United States
Initiated byVoluntary: Firm initiated
Quantity589 Units

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Official FDA record