Stryker Endoscopy Recalls Bullet Forceps Due to Sterilization Documentation Issues
Stryker Endoscopy is recalling 180,573 units of Bullet Forceps 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 the issue is a documentation discrepancy regarding sterilization parameters without reporting any illnesses or injuries, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080041. These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and organs during surgery. 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 means the provided instructions do not validate these specific sterilization processes for the device.
Healthcare facilities and distributors should contact Stryker Endoscopy for further instructions on how to handle the affected units. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- PKG, BULLET FORCEPS, TAPERED, SERRATED, SPOON, P/N 0250080041. 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
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)
- 06CON06097 06CON06098 06CON07969
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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