Stryker Endoscopy Recalls Fundus Grasper Instruments Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 Fundus Grasper instruments 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 and involves a labeling error regarding sterilization methods. The source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of the PKG, 3MM INSERT, FUNDUS GRASPER, 29CM (P/N 0250282050). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The recall covers units distributed nationwide in the United States and internationally to numerous countries including Canada, Mexico, the United Kingdom, and Germany.
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 device is classified as Class II by the FDA. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions. The recall number is Z-0778-2015.
The recalled product
- Product
- PKG, 3MM INSERT, FUNDUS GRASPER, 29CM, P/N 0250282050 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
- 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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