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 explicitly states that the issue is a documentation error in the Instructions for Use regarding sterilization parameters, with no reported illnesses or injuries. This aligns with the rubric for moderate severity involving labeling/documentation issues or low-risk contamination without reported harm.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, GRASPER FORCEP, BOWEL (P/N 0250080324). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery. The recall is classified as Class II by the U.S. Food and Drug Administration.
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. The source text does not report any illnesses, injuries, or deaths associated with this recall.
The affected units were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, the United Kingdom, Germany, and Japan. Healthcare facilities and users should stop using the affected instruments and contact Stryker Endoscopy for further instructions.
The recalled product
- Product
- PKG, GRASPER FORCEP, BOWEL, P/N 0250080324. 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 allo
- 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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