Stryker Endoscopy Recalls Bipolar Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of bipolar forceps 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: This is an FDA Class II recall involving a documentation issue (Instructions for Use) that does not support specific sterilization methods. No illnesses or injuries are reported, and the hazard is theoretical regarding sterilization efficacy, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery. The recall covers units distributed nationwide in the United States and internationally to numerous countries including Canada, Mexico, and various nations in Europe, Asia, and South America.
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 agency has classified this as a Class II recall. The source text does not report any specific illnesses or injuries associated with this defect.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions on the recall process. Consumers are not directly affected as these are professional medical devices used in surgical settings.
The recalled product
- Product
- PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 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) port
- 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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