Stryker Endoscopy Recalls Laparoscopic Instruments Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 laparoscopic instruments because the provided instructions 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 issue regarding sterilization parameters without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures where harm has not been reported.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments and accessories. The specific product identified is the PKG, FUNDUS FORCEPS, P/N 0250080315. These instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during laparoscopic surgery.
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 issue affects the ability to verify proper sterilization for these specific cycles.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, Mexico, the United Kingdom, Germany, and Japan. No specific illnesses or injuries are reported in the source text. Users should refer to the recall notice for specific instructions on how to handle the affected devices.
The recalled product
- Product
- PKG, FUNDUS FORCEPS, P/N 0250080315. 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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