Stryker Laparoscopic Manual Instruments Recalled for Sterilization Instructions
Stryker Endoscopy is recalling 180,573 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 is a documentation issue regarding sterilization instructions without reported injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 5MM INSERT, PARK FORCEPS (P/N 0250080733) and other laparoscopic manual instruments. These instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery. The recall covers units distributed worldwide, including the United States and numerous international locations.
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. This documentation issue affects the ability to properly sterilize the devices using these specific methods.
The source text does not specify a required action for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- PKG, 5MM INSERT, PARK FORCEPS, P/N 0250080733 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 a
- 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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