Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
StrykeFlow 2 System Recalled by Stryker Corporation Due to Routine bioburden testing of certain lots were found...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Corporation directly.
Affected Products
StrykeFlow 2 System, labeled sterile. Includes the following: a. STRYKER LAPAROSCOPIC SUCTION IRRIGATOR, Suction/Irrigator 2 (Model 0250070500); b. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Disposable Strykeflow S/I Tip (Model 0250070505); c. STRYKER STRYKEFLOW SUCTION IRRIGATOR, Strykeflow 2 with Tip (Model 0250070520) STRYKER LAPAROSCOPIC SUCTION IRRIGATOR
Quantity: 60,753 units total
Why Was This Recalled?
Routine bioburden testing of certain lots were found to have levels higher than internal acceptable rates.
Where Was This Sold?
Distributed domestically to . Distributed internationally to Australia and Mexico.
About Stryker Corporation
Stryker Corporation has 108 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report