Stryker Endoscopy Recalls Biopsy Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling biopsy 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 (Instructions for Use) rather than a direct device defect or reported injury. This aligns with the rubric for moderate severity involving labeling or documentation issues.
Plain-English summary
Stryker Endoscopy is recalling the PKG, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery. The recall is due to an issue with the Instructions for Use (IFU 1000-401-070 Revision G or prior).
The parameters provided in the instructions do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods. This means the documentation does not adequately cover these specific sterilization processes for the device.
The affected products were distributed worldwide, including nationwide in the USA and internationally to numerous countries. Users of these devices should consult the recall notice for specific guidance on how to proceed with the affected units.
The recalled product
- Product
- PKG, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. 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 whic
- Manufacturer
- Stryker Endoscopy
- Hazard
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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