Stryker Endoscopy Recalls 11mm Trocars Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of 11mm trocars because the instructions for use do not support specific sterilization methods.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 hazard is a documentation/labeling issue regarding sterilization parameters rather than a reported injury or high-risk pathogen, fitting the Moderate criteria for minor labeling errors or low-risk contamination concerns.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, TROCAR, 11MM, PYRAMIDAL TIP (P/N 0250080156). 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, the United Kingdom, and Germany.
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 distributors should stop using the affected devices and contact Stryker Endoscopy for further instructions. The device does not sustain or support life, but proper sterilization is critical for surgical safety.
The recalled product
- Product
- PKG, TROCAR, 11MM, PYRAMIDAL TIP, P/N 0250080156. 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…
- 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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