Stryker Laparoscopic Needle Holder Recall Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic needle holders 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 issue is a documentation error regarding sterilization parameters rather than a direct defect causing immediate injury, fitting the criteria for moderate risk.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, NEEDLE HOLDER, CURVED RIGHT, P/N 0250080342. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The devices are distributed worldwide, including nationwide in the United States and in numerous international markets.
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 documentation issue affects the ability to properly sterilize the devices using these specific methods.
Healthcare facilities and distributors should stop using the affected products and contact Stryker Endoscopy for further instructions on the recall process.
The recalled product
- Product
- PKG, NEEDLE HOLDER, CURVED RIGHT, P/N 0250080342. 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 frequency (RF) ports whic
- 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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