Stryker Endoscopy Recalls 3mm PEEK Multi-Function Handle Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of 3mm PEEK Multi-Function 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 and involves a documentation issue where instructions do not support specific sterilization methods, fitting the rubric for moderate severity.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of the PKG, 3MM PEEK MULTI-FUNCTION HANDLE (P/N 0250282046). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The devices are distributed worldwide, including in the United States and numerous international locations.
The recall is due to a documentation issue in the Instructions for Use (IFU 1000-401-070 Revision G or prior). The parameters provided in the IFU do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods. This is a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
Healthcare facilities and distributors should stop using the affected handles and contact Stryker Endoscopy for further instructions regarding the return or replacement of the devices.
The recalled product
- Product
- PKG, 3MM PEEK MULTI-FUNCTION HANDLE, P/N 0250282046 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 wh
- 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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