Stryker Laparoscopic Manual Instruments Recalled for Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments 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 a documentation error regarding sterilization parameters rather than a reported injury, hospitalization, or structural defect, fitting the 'Moderate' criteria for minor labeling or documentation issues.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of 5mm PEEK Multi Handle laparoscopic manual instruments (P/N 0250181108). These instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during laparoscopic surgery. The recall covers units distributed worldwide, including the United States and numerous international locations.
The recall was initiated because the parameters provided in the 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 discrepancy means the provided instructions do not validate these specific sterilization processes for the device.
Healthcare facilities and distributors should identify affected units by checking the lot codes listed in the recall notice. Users should stop using the affected instruments and contact Stryker Endoscopy for further instructions regarding the return or replacement of the devices.
The recalled product
- Product
- PKG, ASSY, 5MM PEEK MULTI HANDLE, 45CM, P/N 0250181108 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
- 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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