Stryker Laparoscopic Grasper Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 laparoscopic graspers 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 documentation issue regarding sterilization instructions. There are no reported injuries or illnesses, and the hazard is related to the lack of support for specific sterilization methods in the IFU, fitting the criteria for a moderate severity recall.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of the PKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 20CM (P/N 0250282008). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The recall covers units distributed worldwide, including the United States and numerous international locations.
The recall was initiated 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. This documentation issue affects the ability to verify proper sterilization using those specific methods.
Healthcare facilities and distributors should stop using the affected devices and contact Stryker Endoscopy for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- PKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 20CM, P/N 0250282008 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
- Manufacturer
- Stryker Endoscopy
- Affected units
- 180,573
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 744857
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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