Stryker Endoscopy Recalls Hasson Cannula Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Hasson Cannula units 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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific issue is a documentation error in the Instructions for Use regarding sterilization methods, which fits the criteria for a moderate severity labeling or documentation issue.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of the PKG, HASSON CANNULA, 11MM AUTOMATIC VALVE, STOP COCK (P/N 0250080179). 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. The device is intended for cutting, holding, grasping, and manipulating tissue and organs during laparoscopic surgery.
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, HASSON CANNULA, 11MM AUTOMATIC VALVE, STOP COCK, P/N 0250080179. 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 freq
- 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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