Stryker Endoscopy Recalls Bipolar Forceps Due to Sterilization Instructions
Stryker Endoscopy is recalling 180,573 units of bipolar 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 does not report any hospitalizations, injuries, or illnesses. The hazard is a documentation issue regarding sterilization parameters, which aligns with the 'Moderate' criteria for minor labeling or documentation errors without reported harm.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of PKG, Bipolar Forceps, Micro Tip, 33CM (P/N 0250080362). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue, organs, and surgical auxiliaries. Some instruments have radio frequency (RF) ports for electrosurgery. The devices are distributed worldwide, including in 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. The agency has classified this recall as Class II. 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 medical devices at home, as they are intended for professional surgical use.
The recalled product
- Product
- PKG, BIPOLAR FORCEPS, MICRO TIP, 33CM, P/N 0250080362. 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
- 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)
- 716993 816614 816615 816616 913650 913988 914125 1016734
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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