Stryker Recalls Curved Trocar Wound Drains for Sterility Breach
Stryker is voluntarily recalling 3/16 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 a voluntary precautionary action for a potential sterility breach in packaging, which fits the criteria for a moderate severity score as no specific illnesses or injuries are reported in the source text.
Plain-English summary
Stryker Instruments Division of Stryker Corporation is voluntarily recalling 3/16 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. The affected products include a curved metal trocar attached to a flexible wound drain tube, equipped with a polymeric trocar guard, as well as double trocar wound drains with metal trocars on either side of the tube.
The recall involves 628 boxes (6,280 units) of Part Number 0225-015-000. The specific lot numbers affected are 10083012, 10349012, 11224012, 12151012, 13092012, 13196012, 14034012, 14246012, 10125012, 11014012, 11257012, 12286012, 13119012, 13248012, 14127012, 14263012, 10162012, 11059012, 12039012, 12341012, 13135012, 13274012, 14165012, 10273012, 11108012, 12075012, 13010012, 13172012, 13326012, 14177012, 10309012, 11160012, 12080012, 13065012, 13191012, 14021012, and 14231012.
The products were distributed worldwide, including in the United States, Australia, Great Britain, The Netherlands, Spain, Romania, Greece, Switzerland, South Africa, and Japan. Healthcare facilities and consumers should check their inventory for these specific part and lot numbers and contact Stryker Instruments for further instructions regarding the recall.
The recalled product
- Product
- 3/16 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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