Stryker Laparoscopic Forceps Recalled for Sterilization Instructions Error
Stryker Endoscopy is recalling 180,573 laparoscopic dissecting forceps units 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, which is typically associated with a temporary or medically reversible adverse health consequence. The hazard is a documentation error regarding sterilization parameters, which fits the criteria for a moderate severity recall involving labeling or instruction issues without reported injuries.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 5MM X 45CM INSERT, DISSECTING FORCEPS (P/N 0250080762). 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 may affect the proper sterilization of the devices.
Healthcare facilities and distributors should stop using the affected instruments and contact Stryker Endoscopy for further instructions. The specific lot codes associated with this recall are 444728, 940354, 1045171, 1340995, 1341513, 1441558, and 1441959.
The recalled product
- Product
- PKG, 5MM X 45CM INSERT, DISSECTING FORCEPS, P/N 0250080762 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) p
- 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)
- 444728 940354 1045171 1340995 1341513 1441558 1441959
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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