Stryker Endoscopy Recalls Laparoscopic Graspers Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of laparoscopic graspers because the instructions for use do not support specific sterilization methods.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
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 issue regarding sterilization parameters, which fits the criteria for a Low severity score (documentation issues).
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 29CM (P/N 0250282055). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The recall is due to a documentation issue where 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.
The affected devices were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Canada, the United Kingdom, Germany, and Japan. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Healthcare facilities and distributors should stop using the affected devices and contact Stryker Endoscopy for further instructions. Consumers should not use these devices if they have them in their possession.
The recalled product
- Product
- PKG, 3MM INSERT, BLUNT WITH SPOON, GRASPER, 29CM, P/N 0250282055 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
- Hazard
- Affected units
- 180,573
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 245448 340992
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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