Stryker Endoscopy Recalls 10mm Clip Applying Forceps Due to Sterilization Documentation
Stryker Endoscopy is recalling 180,573 units of 10mm Clip Applying Forceps 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 source text identifies the issue as a documentation error regarding sterilization parameters rather than a reported injury or high-risk pathogen, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 10MM CLIP APPLYING FORCEPS, P/N 0250080558. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries during endoscopic procedures. The devices are distributed worldwide, including nationwide in the United States and in numerous international locations.
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 verify proper sterilization for these specific cycles.
Healthcare facilities and distributors should stop using the affected devices and contact Stryker Endoscopy for further instructions. The recall covers specific lot codes identified in the agency's structured data.
The recalled product
- Product
- PKG, 10MM CLIP APPLYING FORCEPS, P/N 0250080558. 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 which
- 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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