Stryker Laparoscopic Cannula Recall Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic cannulas 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, which typically corresponds to a moderate severity score. The hazard is a documentation error regarding sterilization instructions rather than a direct physical defect or reported injury.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of the PKG, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR (P/N 0250080171). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgical procedures. The devices are distributed worldwide, including nationwide in the United States and internationally to numerous countries.
The recall is issued 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 documentation issue affects the ability to properly sterilize the devices using these specific methods.
Healthcare facilities and distributors should stop using the affected devices and contact Stryker Endoscopy for further instructions on the recall.
The recalled product
- Product
- PKG, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR, P/N 0250080171. 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 f
- Manufacturer
- Stryker Endoscopy
- Affected units
- 180,573
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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