Stryker Laparoscopic Hook Scissors Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of laparoscopic hook scissors because the instructions for use do not support specific sterilization methods.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is driven by a documentation issue where the Instructions for Use do not support specific sterilization cycles, which aligns with the rubric for Low severity (documentation issues).
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, HOOK SCISSORS, P/N 0250080020. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. The devices are designed to be used endoscopically through cannulae and do not sustain or support life.
The recall is issued 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 affects the ability to verify proper sterilization for these specific cycles.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Users should stop using the affected instruments and contact Stryker Endoscopy for further instructions.
The recalled product
- Product
- PKG, HOOK SCISSORS, P/N 0250080020. 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 allow them
- Manufacturer
- Stryker Endoscopy
- Hazard
- 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)
- 06CON06092 AA3
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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