Stryker Endoscopy Recalls Aspiration Needles Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 aspiration needles 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 error regarding sterilization parameters rather than a reported injury, hospitalization, or structural defect, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, ASPIRATION NEEDLE, 45 CM (P/N 0250080703). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgical procedures. The devices are distributed worldwide, including nationwide in the United States and internationally to numerous countries.
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 means the provided instructions do not validate these specific sterilization processes for the device.
Healthcare facilities and distributors should stop using the affected devices and contact Stryker Endoscopy for further instructions. The recall number is Z-0731-2015.
The recalled product
- Product
- PKG, ASPIRATION NEEDLE, 45 CM, P/N 0250080703 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 which al
- 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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