Stryker Laparoscopic Forceps Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of OP-VIOPSY 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 classified as FDA Class II, but the hazard is a documentation issue regarding sterilization parameters rather than a direct defect causing injury. Per the rubric, documentation issues and packaging-only problems are typically scored as Low (1) or Moderate (2). Given the lack of reported injuries and the nature of the defect being in the instructions rather than the device itself, a score of 1 is appropriate.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of OP-VIOPSY Forceps, Spoon Jaw, P/N 0250080246. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. The devices are distributed worldwide, including in the United States and numerous international locations.
The recall is due to an error in the Instructions for Use (IFU 1000-401-070 Revision G or prior). The parameters provided in the IFU do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods. This documentation issue affects the ability to properly sterilize the instruments using these specific methods.
Healthcare facilities and users should stop using the affected instruments and contact Stryker Endoscopy for further instructions on how to proceed with the recall.
The recalled product
- Product
- PKG, OP-VIOPSY FORCEPS, SPOON JAW, P/N 0250080246. 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 wh
- Manufacturer
- Stryker Endoscopy
- 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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