Stryker Metzenbaum Scissors Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Metzenbaum Scissors 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, which fits the criteria for moderate severity involving minor labeling or documentation errors.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of Metzenbaum Scissors, Straight (P/N 0250080264). 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, the United Kingdom, Germany, and Japan.
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 may affect the proper sterilization of the devices.
Healthcare providers and facilities that have received these instruments should stop using them and contact Stryker Endoscopy for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- PKG, METZENBAUM SCISSORS, STRAIGHT, P/N 0250080264. 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
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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