Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error
Stryker Endoscopy is recalling 180,573 laparoscopic manual instruments 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 the issue as a documentation error in the Instructions for Use regarding sterilization parameters, with no reported injuries or illnesses. This aligns with the rubric for moderate severity involving labeling or documentation issues.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, BIOPSY FORCEPS, SPOON W/PIN (P/N 0250080291). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, 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 Laparoscopic Manual Instruments 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 guidance provided to users regarding the sterilization of the devices.
Healthcare facilities and users of these instruments should stop using the affected products and contact Stryker Endoscopy for further instructions on how to proceed with the recall.
The recalled product
- Product
- PKG, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. 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 whic
- 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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