Stryker Laparoscopic Dissector Recall Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 laparoscopic dissectors 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, but the source text identifies a documentation and labeling error regarding sterilization parameters rather than a reported injury or structural defect, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of the 5mm x 45cm Insert, Right Angle Dissector, Long Jaw (P/N 0250080761). The recall involves laparoscopic manual instruments intended for cutting, holding, grasping, and manipulating tissue during surgery.
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 discrepancy affects the ability to verify proper sterilization for these specific cycles.
The affected units were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions regarding the recall.
The recalled product
- Product
- PKG, 5MM X 45CM INSERT, RIGHT ANGLE DISSECTOR, LONG JAW, P/N 0250080761 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 fre
- 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)
- 444163 641227 1146775 1244652 1246196 1341895
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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