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

Medical DevicesSource: FDA (device) · Date: 2026-08-12

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Stryker Corporation
Product
STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
Reason / hazard
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
Classification
Class II
Status
Ongoing
Distribution / sold at
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.
Recall initiated
2026-06-08
Code info
GTIN 0761332706146, Batch Numbers: 24297FG2, 24306FG2, 24344FG2, 25007FG2, 25065FG2, 25091FG2, 25168FG2.
Product quantity
589 Units
Voluntary mandated
Voluntary: Firm initiated
City
San Jose
State
CA
Country
United States
Event id
99340
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