Recall Z-2171-2025— Stryker Corporation

Name: FDA recall Z-2171-2025
Creator: U.S. Food and Drug Administration
Published: 2025-06-18

Class II · Ongoing

Class II FDA medical device recall by Stryker Corporation, initiated 2025-06-18. It names one FDA 510(k) clearance: K954726. Product: Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip. Reason: Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction..

Recalling firm: Stryker Corporation
Classification: Class II
Status: Ongoing
Initiated: 2025-06-18
Firm location: San Jose, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K954726 — STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION)Stryker Endoscopy·cleared 1995-11-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.