Stryker Endoscopy Recalls 180,573 Cobra Grasper Instruments Due to Sterilization Labeling
Stryker Endoscopy is recalling 180,573 Cobra 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 the hazard is a labeling error regarding sterilization parameters rather than a reported injury or high-risk pathogen, fitting the Moderate criteria for minor labeling errors or low-risk issues.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of the PKG, 3MM INSERT, COBRA GRASPER, 20CM (P/N 0250282007). 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 is a Class II recall, indicating that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions regarding the return or replacement of the devices.
The recalled product
- Product
- PKG, 3MM INSERT, COBRA GRASPER, 20CM, P/N 0250282007 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 w
- 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)
- 842586 844134 846790 1045475 1143118 1143135
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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