Stryker Recalls Wound Drains Due to Potential Sterility Breach
Stryker Instruments is voluntarily recalling specific wound drain products because the packaging may have a sterility breach.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary action for a potential sterility breach in packaging, with no reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb. The recall is being conducted because of a potential sterility breach in the product packaging.
The affected products include the 3/16 in. Double Trocar with Wound Drain and the Curved Trocar with Wound Drain. The recall covers 1,375 boxes, containing 13,750 individual units. These products were distributed worldwide, including in the United States, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan.
Healthcare providers and consumers should stop using these products and contact Stryker Instruments for further instructions. The specific part number is 0215-015-200, and the affected lot numbers are listed in the official recall documentation.
The recalled product
- Product
- 3/16 in. Double Trocar with Wound 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…
- 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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