Stryker Laparoscopic Grasper Forceps Recalled Due to Sterilization Instructions
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 no illnesses or injuries have been reported, and the hazard is related to documentation/labeling of sterilization methods rather than a direct structural defect or reported harm.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, GRASPER FORCEPS, DELICATE, FENESTRATED, P/N 0250080322. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries during endoscopic procedures. The devices are distributed worldwide, including nationwide in the United States and in 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. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and users should stop using the affected devices and contact Stryker Endoscopy for further instructions regarding the recall.
The recalled product
- Product
- PKG, GRASPER FORCEPS, DELICATE, FENESTRATED, P/N 0250080322. 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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