Stryker Laparoscopic Manual Instruments Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments 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 error regarding sterilization parameters rather than a direct physical defect or reported injury, fitting the 'Moderate' criteria for minor labeling/documentation issues.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of 5mm rotating handle laparoscopic manual instruments, including insulated shafts and handles, due to errors in the Instructions for Use (IFU). The affected devices are intended for cutting, holding, grasping, and manipulating tissue during laparoscopic surgery.
The recall was initiated because the parameters provided in the IFU (Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods. This documentation error could potentially affect the proper sterilization of the instruments if users rely on the incorrect parameters.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Users should stop using the affected instruments and contact Stryker Endoscopy for further instructions on how to proceed.
The recalled product
- Product
- PKG, 5MM ROTATING HANDLE, INSULATED SHAFT/ HANDLE 45CM LENGTH, P/N 0250080595 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…
- 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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