Stryker Laparoscopic Needle Holder Recall Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 laparoscopic needle holders 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 identifies a documentation error regarding sterilization parameters rather than a physical defect or reported injury, aligning with the 'Moderate' criteria for minor labeling/documentation issues.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 5MM SHAFT, NEEDLE HOLDER, CURVED RIGHT, 45CM (P/N 0250080590). 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 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 discrepancy means the provided instructions do not validate these specific sterilization processes for the device.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible health consequences.
The recalled product
- Product
- PKG, 5MM SHAFT, NEEDLE HOLDER, CURVED RIGHT, 45CM, P/N 0250080590 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
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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