Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 units of laparoscopic grasper forceps 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 minor labeling or documentation issues.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, GRASPER FORCEPS, NARROW JAW (P/N 0250080287). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. The devices are 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 affects the ability to verify proper sterilization for these specific cycles.
The recall is classified as Class II by the FDA. Users should contact Stryker Endoscopy for further instructions regarding the affected devices.
The recalled product
- Product
- PKG, GRASPER FORCEPS, NARROW JAW, P/N 0250080287. 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 whi
- 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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