Z-2170-2025 Class II Ongoing

Recalled by Stryker Corporation — San Jose, CA

FDA device recall Z-2170-2025 was initiated by Stryker Corporation on June 18, 2025 and is designated Class II. Reason for recall: Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. The recall status is ongoing. Affected quantity: N/A.

Recall Details

Product Type
Devices
Report Date
July 30, 2025
Initiation Date
June 18, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
N/A

Product Description

Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip

Reason for Recall

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

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.

Code Information

UDI: 07613327061390