Recall Z-2170-2025
Stryker Corporation · initiated June 18, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
Codes / lots: UDI: 07613327061390
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.
FDA-determined 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.
Details
- Recall number
- Z-2170-2025
- Initiated
- June 18, 2025
- Posted by FDA
- July 23, 2025
- Product code
- GCJ – Laparoscope, General & Plastic Surgery
- 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…
- Recalling firm
- Stryker Corporation, San Jose, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2171-2025 Class II | Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable TipDue to complaints their is the potential that irrigation solution may leaked into the handpiece and battery… | 06/18/2025Open, Classified |