Stryker Endoscopy Recalls Laparoscopic Graspers Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of laparoscopic atraumatic graspers 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, but the source text explicitly states no illnesses or injuries are reported and the hazard is related to documentation/sterilization parameters rather than a direct defect causing harm, fitting the 'voluntary precautionary recalls' or 'minor labeling errors' criteria for a Moderate score.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 3MM INSERT, ATRAUMATIC GRASPER, SINGLE ACTION, 29CM (P/N 0250282099). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The affected units were distributed worldwide, including nationwide in the United States and in numerous international locations.
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 devices.
Healthcare facilities and distributors should stop using the affected products and contact Stryker Endoscopy for further instructions. No specific illnesses or injuries are reported in the source text.
The recalled product
- Product
- PKG, 3MM INSERT, ATRAUMATIC GRASPER, SINGLE ACTION, 29CM, P/N 0250282099 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 fr
- 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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