Recall Z-2171-2025 ยท GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Stryker Corporation
Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
| Date | Jul 23, 2025 (initiated Jun 18, 2025) |
| Status | Open, Classified |
| Reason | Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. |
| Root cause | Under Investigation by 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 |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954726 | STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) Stryker Endoscopy, Nov 29, 1995 |