Stryker Recalls Curved Trocar Wound Drains for Potential Sterility Breach
Stryker Instruments is voluntarily recalling 1/8 in. Curved Trocar with Wound Drain devices due to a potential sterility breach in the packaging.
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 classified as FDA Class II, but the source text describes a 'potential' sterility breach and does not report any hospitalizations or illnesses, fitting the criteria for a voluntary precautionary recall.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is voluntarily recalling the 1/8 in. Curved Trocar with Wound Drain and Double Trocar with Wound Drain devices. The recall is being conducted because of a potential sterility breach in the packaging of these medical devices.
The affected products include the curved trocar wound drain, which features a curved metal trocar attached to a flexible wound drain tube, and the double trocar wound drain, which has metal trocars on either side of the tube. Both types are equipped with polymeric trocar guards for protection during handling. The recall involves 1,457 boxes, containing 14,570 individual units.
These devices were distributed worldwide, including in the United States, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan. The specific part number is 0225-018-000, and the affected lot numbers are listed in the official recall documentation. Healthcare providers and facilities should stop using these devices and contact Stryker Instruments for instructions on return or replacement.
The recalled product
- Product
- 1/8 in. Curved 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
- Hazard
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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