Stryker Endoscopy Recalls Laparoscopic Trocars Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 laparoscopic trocars because the provided 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 identifies the issue as a documentation discrepancy in the Instructions for Use regarding sterilization parameters, with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, TROCAR 5.5MM PYRAMIDAL TIP (P/N 0250080154). 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 in numerous international markets.
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. This documentation discrepancy affects the ability to verify proper sterilization for these specific cycles.
Healthcare facilities and users should stop using the affected devices and contact Stryker Endoscopy for further instructions regarding the recall and replacement of the instruments.
The recalled product
- Product
- PKG, TROCAR 5.5MM PYRAMIDAL TIP, P/N 0250080154; 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
- 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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