Stryker Peritoneal Scissors Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of 5mm x 45cm Peritoneal 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. The hazard is a documentation issue regarding sterilization parameters, which fits the rubric for moderate severity involving labeling or documentation errors without reported injuries.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of 5mm x 45cm Peritoneal Scissors (P/N 0250080751). The recall affects Laparoscopic Manual Instruments intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The devices are distributed worldwide, including in the United States and numerous international locations.
The recall was initiated because the parameters provided in the 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 instruments.
Healthcare facilities and distributors should stop using the affected products and contact Stryker Endoscopy for further instructions. The device does not sustain or support life.
The recalled product
- Product
- PKG, 5MM X 45CM, INSERT, PERITONEAL SCISSORS, P/N 0250080751 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)
- 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)
- 440809 746857 747141 1140002 1243796
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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