Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Labeling Errors
Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the instructions for use do not support specific sterilization methods.
What this means for you
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 hazard is a labeling error regarding sterilization parameters rather than a direct defect causing injury or death. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments and accessories. The affected products include the PKG, CANNULA 8MM AUTOMATIC VALVE STOP COCK, W/O TROCAR, P/N 0250080172, as well as other laparoscopic instruments intended for cutting, holding, grasping, and manipulating tissue.
The recall was initiated because the parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods. This labeling discrepancy means the provided instructions do not accurately reflect the sterilization capabilities of the devices.
The affected units were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, Mexico, the United Kingdom, Germany, and Japan. The source text does not specify specific lot numbers or dates of manufacture beyond the IFU revision. Users should consult the recall notice for specific instructions on how to handle these devices.
The recalled product
- Product
- PKG, CANNULA 8MM AUTOMATIC VALVE STOP COCK, W/O TROCAR, P/N 0250080172 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio freq
- Manufacturer
- Stryker Endoscopy
- Affected units
- 180,573
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 (1)
- 26356 34795
Distribution
Part of a larger recall action
This product is one of 207 recalled by Stryker Endoscopy 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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