Stryker Endoscopy Recalls 5mm PEEK Monopolar Handles Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of 5mm PEEK Monopolar Handles 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 methods rather than a direct structural defect or reported injury.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of the 5mm PEEK Monopolar Handle (P/N 0250080617). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. The devices are distributed worldwide, including in the United States and 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 protocols for these specific instruments.
Healthcare facilities and users should stop using the affected devices and contact Stryker Endoscopy for further instructions on how to proceed with the recall.
The recalled product
- Product
- PKG, 5MM PEEK MONOPOLAR HANDLE, P/N 0250080617 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 a
- 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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