Stryker Debaney Forceps Recalled Due to Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of Debaney 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 identifies the issue as a documentation error in the Instructions for Use rather than a physical defect or reported injury, fitting the criteria for a moderate severity labeling/documentation issue.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, DEBANEY FORCEPS, P/N 0250080314. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. The devices are distributed worldwide, including in the United States and numerous international locations.
The recall is issued 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 error may affect the proper sterilization of the instruments.
Healthcare facilities and users should stop using the affected instruments and contact Stryker Endoscopy for further instructions on how to proceed.
The recalled product
- Product
- PKG, DEBANEY FORCEPS, P/N 0250080314. 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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