Stryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
Stryker is recalling Strykeflow Suction/Irrigator PS devices due to reports of leaking from the handpiece during use.
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: The recall involves a medical device with a functional defect (leaking) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling 589 units of the Strykeflow Suction/Irrigator PS (Catalog Number 0250070540). The recall was initiated because of an increased amount of reported complaints consistently describing leaking from the handpiece during use.
The affected devices were distributed worldwide, including in the United States and 18 other countries. The specific batch numbers involved are 24297FG2, 24306FG2, 24344FG2, 25007FG2, 25065FG2, 25091FG2, and 25168FG2.
Healthcare providers and consumers should stop using the affected devices and contact Stryker Corporation for further instructions on the recall.
The recalled product
- Product
- STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
- Manufacturer
- Stryker Corporation
- Hazard
- Affected units
- 589
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 (8)
- GTIN 0761332706146
- Batch Numbers: 24297FG2
- 24306FG2
- 24344FG2
- 25007FG2
- 25065FG2
- 25091FG2
- 25168FG2.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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