Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Labeling Error
Stryker Endoscopy is recalling 180,573 units of 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 and involves a documentation/labeling error regarding sterilization methods, which fits the rubric for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments, specifically the 3mm Insert, Schertl Grasper, Fenestrated, 29cm (P/N 0250282053). The recall is due to a documentation error in the Instructions for Use (IFU 1000-401-070 Revision G or prior), which do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods.
The affected instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during laparoscopic surgery. The devices were distributed worldwide, including nationwide in the United States and internationally to numerous countries across the Americas, Europe, Asia, and the Middle East.
Healthcare facilities and users should stop using the affected instruments and contact Stryker Endoscopy for further instructions. The recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PKG, 3MM INSERT, SCHERTL GRASPER, FENESTRATED, 29CM, P/N 0250282053 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 frequen
- 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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