Stryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation 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, but the source text explicitly states no illnesses or injuries have been reported, and the hazard is a documentation error regarding sterilization methods rather than a direct defect causing harm.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of laparoscopic manual instruments, including specific tubing packages (P/N 0250080208), due to a documentation error in the Instructions for Use (IFU 1000-401-070 Revision G or prior). The parameters provided in the IFU do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods. These instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during laparoscopic surgery.
The recall affects products distributed worldwide, including the United States and numerous international markets. The agency has classified this as a Class II recall. The source text does not report any illnesses or injuries associated with this issue. Consumers and healthcare facilities should stop using the affected instruments and contact Stryker Endoscopy for further instructions.
The recalled product
- Product
- PKG, LUERLOCK, FEMALE, 6MM TUBING, P/N 0250080208. 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 wh
- 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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