Stryker Laparoscopic Grasper Recall Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 laparoscopic blunt graspers 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 describes a documentation error regarding sterilization parameters without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving labeling or documentation issues.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of the PKG, 3MM INSERT, BLUNT GRASPER, 20CM (P/N 0250282009). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The recall is classified as Class II by the FDA.
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 affects the proper sterilization of the devices.
The affected units were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Healthcare providers and facilities should stop using the affected instruments and contact Stryker Endoscopy for further instructions on the recall.
The recalled product
- Product
- PKG, 3MM INSERT, BLUNT GRASPER, 20CM, P/N 0250282009 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 w
- 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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