Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments because the provided 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 the hazard involves a documentation error regarding sterilization parameters rather than a reported injury or structural defect, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. 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 in the United States and 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 discrepancy may affect the proper sterilization of the instruments.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions on how to proceed with the recall.
The recalled product
- Product
- PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. 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 (
- 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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