Stryker Laparoscopic Scissors Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 units of 3mm Hook Scissors 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 and involves a documentation error regarding sterilization instructions. No injuries, illnesses, or deaths are reported in the source text, and the hazard is related to labeling/documentation rather than a direct physical defect causing immediate harm.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 3MM INSERT, HOOK SCISSORS, 20CM, P/N 0250282002. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. 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 error affects the guidance provided to users regarding the proper sterilization of the device.
Healthcare facilities and users of these instruments should stop using the affected units and contact Stryker Endoscopy for further instructions on how to proceed with the recall.
The recalled product
- Product
- PKG, 3MM INSERT, HOOK SCISSORS, 20CM, P/N 0250282002 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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