Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Instructions
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 explicitly states no illnesses or injuries have been reported, and the hazard is related to documentation/instructions rather than a direct physical defect causing immediate harm.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments, specifically the PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 29CM (P/N 0250282058). These instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery. The recall is due to an issue with 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 products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, the United Kingdom, Germany, and Japan. The recall is classified as Class II by the U.S. Food and Drug Administration. No illnesses or injuries have been reported in connection with this recall.
Healthcare facilities and users should stop using the affected instruments and contact Stryker Endoscopy for further instructions on how to proceed with the recall and replacement of the instructions.
The recalled product
- Product
- PKG, 3MM INSERT, MARYLAND, FORCEPS CURVED, 29CM, P/N 0250282058 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 (
- 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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