—#214315

Product

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

FDA product code: GCX — Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K954726
Affected lot / code info: UDI: 07613327061369

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Stryker Corporation
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

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.

Timeline

Recall initiated: 2025-06-18
Posted by FDA: 2025-07-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214315. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.