Stryker Endoscopy Recalls Laparoscopic Micro Scissors Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of laparoscopic micro 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 identifies a documentation issue regarding sterilization parameters rather than a reported injury, defect, or contamination, aligning with the 'Moderate' criteria for minor labeling or documentation errors.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, MICRO SCISSORS, STRAIGHT, P/N 0250080029. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries.
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 affects the validation of specific sterilization processes for the device.
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, MICRO SCISSORS, STRAIGHT, P/N 0250080029. 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 which
- 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)
- 06CON06096 06CON06326 06CON08778
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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