Stryker Laparoscopic Knot Pushers Recalled for Sterilization Labeling Errors
Stryker Endoscopy is recalling 180,573 laparoscopic knot pushers 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 for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, KNOT PUSHER 5MM OPEN (P/N 0250080132). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The recall is due to a labeling error in the Instructions for Use (IFU 1000-401-070 Revision G or prior), which do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, the United Kingdom, Germany, and Japan. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible adverse health consequences.
Healthcare facilities and users should stop using the affected lot numbers and contact Stryker Endoscopy for further instructions on how to proceed with the recall.
The recalled product
- Product
- PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 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
- 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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