Stryker Endoscopy Recalls Claw Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of Claw Forceps 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. This falls under the 'Low' severity criteria for documentation issues and packaging-only problems, as no direct physical defect or reported injury is cited.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, CLAW FORCEPS (P/N 0250080244). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. The devices are distributed worldwide, including nationwide in the United States and in numerous international locations.
The recall is issued 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 issue affects the ability to verify proper sterilization for these specific cycles.
Healthcare facilities and users should stop using the affected devices and contact Stryker Endoscopy for further instructions regarding the recall and potential remediation.
The recalled product
- Product
- PKG, CLAW FORCEPS, P/N 0250080244. 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 t
- Manufacturer
- Stryker Endoscopy
- Hazard
- 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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