Stryker Endoscopy Recalls Serrated Operating Scissors Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of Serrated Operating 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a documentation issue regarding sterilization parameters, which aligns with the criteria for a moderate severity score involving minor labeling or documentation errors.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, OPERATING SCISSORS, SERRATED, P/N 0250080247. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The affected units were 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. The device does not sustain or support life.
Healthcare facilities and users should stop using the affected instruments and contact Stryker Endoscopy for further instructions regarding the recall.
The recalled product
- Product
- PKG, OPERATING SCISSORS, SERRATED, P/N 0250080247. 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
- 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)
- 343874 845850 847846 847847 1340931
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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