Stryker Laparoscopic Forceps Recalled Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 Mixter Forceps units 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 does not report any hospitalizations, injuries, or illnesses, and the hazard is related to documentation and sterilization parameters rather than a direct structural defect or contamination.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, MIXTER FORCEPS (P/N 0250080010). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery. The recall is classified as Class II by the FDA.
The recall was initiated 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. The device does not sustain or support life.
The affected units were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Healthcare facilities should stop using the affected instruments and contact Stryker Endoscopy for further instructions.
The recalled product
- Product
- PKG, MIXTER FORCEPS, P/N 0250080010. 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
- 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)
- 06CON06091 06CON06323
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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