Stryker Endoscopy Recalls 5mm Metzenbaum Scissors Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of 5mm 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/labeling error regarding sterilization methods. The source text does not report any illnesses or injuries, and the hazard is theoretical, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 5MM INSERT, ENDO METZENBAUM SCISSORS, CURVED 45CM (P/N 0250080575). The recall is due to a documentation issue where 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 affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, Mexico, Germany, and Japan. The recall is classified as Class II by the FDA.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for instructions on how to proceed. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- PKG, 5MM INSERT, ENDO METZENBAUM SCISSORS, CURVED 45CM, P/N 0250080575 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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