Stryker Endoscopy Recalls 3.5mm Pyramidal Trocars Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of 3.5mm Pyramidal Trocars 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 source text identifies a documentation/labeling error regarding sterilization parameters without reporting any illnesses, injuries, or deaths. This aligns with the rubric for moderate severity involving minor labeling errors or low-risk issues.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of 3.5mm Pyramidal Trocars, Long (P/N 0250080730). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgical procedures. The devices are distributed worldwide, including nationwide in the United States and internationally to numerous countries.
The recall is being conducted 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. This labeling discrepancy means the provided documentation does not accurately reflect the supported sterilization protocols for the device.
Healthcare facilities and distributors should stop using the affected devices and contact Stryker Endoscopy for further instructions on how to return or replace the units. The recall number is Z-0736-2015.
The recalled product
- Product
- PKG, ASSY, 3.5MM PYRAMIDAL TROCAR, LONG P/N 0250080730 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
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)
- 34639 34941 44300 67660
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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