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Open, Classified

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

FDA Recall Z-2171-2025 · Posted 2025-07-23

Recalling FirmStryker Corporation
Recall StatusOpen, Classified
Product CodeGCX
Date Initiated2025-06-18

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.

Firm Action

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.

Root Cause

Under Investigation by firm

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K954726STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)Stryker Endoscopy · 1995-11-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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