Stryker Endoscopy Recalls Laparoscopic Grasper Forceps Due to Sterilization Documentation Issues
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
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class II but involves a documentation issue where the Instructions for Use do not support specific sterilization methods. No injuries, illnesses, or structural defects are reported, fitting the criteria for a Low severity documentation issue.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery. The recall covers units distributed nationwide in the United States and internationally to numerous countries including Canada, the United Kingdom, and Australia.
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. This is a documentation and labeling issue regarding the approved sterilization protocols for the device.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions. The device does not sustain or support life.
The recalled product
- Product
- PKG, GRASPER FORCEPS, SERRSTED FENESTRATED, P/N 0250080318. 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)
- 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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