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Recall Observatory FDA recall evidence

Device product

Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip

Z-2171-2025

June 18, 2025

Class II

Product summary

Firm
Stryker Corporation
Event
Event 97039
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2171-2025

Official wording

Reason: Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.

Code information: UDI: 07613327061369

Distribution pattern: Worldwide - US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Argentina, Philippines, Singapore, China, Japan, Canada, Korea.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.