Stryker Recalls Trocar Wound Drains Due to Potential Sterility Breach
Stryker Instruments is voluntarily recalling specific trocar wound drains and ambulating bulbs because of a potential sterility breach in the packaging.
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 is classified as FDA Class II, and the hazard involves a potential sterility breach in a medical device, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is voluntarily recalling the 3/16 in. Trocar with Single Drain, Curved Trocar with Wound Drain, Double Trocar with Wound Drain, and Ambulating Bulb. The recall is being conducted due to a potential sterility breach in the packaging of these medical devices.
The affected products include 2,711 boxes (27,110 units) distributed worldwide, including the United States, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan. The specific part number is 0215-015-000, and the recall covers a specific list of lot numbers provided in the agency's structured data.
Healthcare providers and consumers should stop using these devices and contact Stryker Instruments for further instructions on how to return or dispose of the affected units. This action is taken to ensure patient safety by preventing the use of devices that may not be sterile.
The recalled product
- Product
- 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from t
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Stryker Instruments Div. of 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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