Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling
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 and involves a labeling error regarding sterilization methods, which fits the rubric criteria for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, SPRING HANDLE, P/N 0250080237 Laparoscopic Manual Instruments. These instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during laparoscopic surgery. The recall covers units distributed nationwide in the United States and internationally to numerous countries including Canada, Mexico, and various nations in Europe, Asia, and South America.
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 labeling discrepancy means the provided documentation does not accurately reflect the supported sterilization processes for these devices.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible health consequences.
The recalled product
- Product
- PKG, SPRING HANDLE, P/N 0250080237. 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 allow them
- 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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