Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments 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, and the hazard involves incorrect sterilization instructions which could lead to inadequate sterilization, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 Laparoscopic Manual Instruments. These instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. The recall covers units distributed worldwide, including the United States and numerous international locations.
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. The device does not sustain or support life.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions regarding the return or replacement of the devices.
The recalled product
- Product
- PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 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
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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