Stryker StrykeFlow Suction Irrigator Recalled for Potential Liquid Leakage
Stryker is recalling its StrykeFlow suction/irrigator device due to potential irrigation solution leakage into the handpiece and battery pack, which could cause device malfunction.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall with no reported illnesses or injuries. The hazard—potential irrigation solution leakage causing device malfunction—is theoretical. Per the severity rubric, when no illnesses are reported and the hazard is theoretical, the maximum score is 3 (High). The product presents a risk of failure during medical use.
Plain-English summary
Stryker Corporation is recalling the StrykeFlow Disposable Suction/Irrigator (Reference 0250070500) due to a potential defect. The device is designed for suction and irrigation applications in medical procedures.
The recall was initiated due to complaints indicating that irrigation solution may leak into the handpiece and battery pack, potentially causing the device to malfunction.
The affected devices have been distributed worldwide, including throughout all U.S. states and in Argentina, Philippines, Singapore, China, Japan, Canada, and Korea.
Affected healthcare facilities and medical professionals should contact Stryker Corporation for instructions regarding the recalled devices.
The recalled product
- Product
- Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip
- Manufacturer
- Stryker Corporation
- Category
- Medical Device
- Hazard
- liquid-ingress
- device-malfunction
- electrical-hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 07613327061390
Distribution
Distributed nationwide across the United States.
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