Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
- Company
- Stryker Corporation
- Recall Initiated
- June 18, 2025
- Posted
- July 23, 2025
- Recall Number
- Z-2170-2025
- Firm Location
- San Jose, CA
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
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.
Lot / Code Info
UDI: 07613327061390
Root Cause
Under Investigation by firm
Action Taken
On June 18, 2025, Stryker issued a "Urgent: Medical Device Recall" Notification to affected consignees. On November 20, 2025, Stryker initiated a recall notification update. Stryker ask consignees to take the following actions: 1. Inform individuals within your organization who need to be aware of this action. 2. Check your internal inventory to locate the affected product. 3. If affected product is found, quarantine and initiate the return process for affected units. 3a. Please complete Business Reply Form or use QR Code on Attachment A to return product. 4. If affected product is NOT found: 4a. Please complete Business Reply Form or use QR Code on Attachment A. 5. Maintain awareness of this communication internally until all required actions have been completed within your facility. Response is required.