Stryker Laparoscopic Reducers Recalled for Sterilization Parameter Errors
Stryker Endoscopy is recalling 180,573 laparoscopic reducers because the instructions for use do not support specific sterilization methods.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 and involves a documentation error regarding sterilization parameters. The source explicitly states no illnesses or injuries are reported, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Endoscopy is recalling 180,573 units of the PKG, 12.5/11MM - 5.5 Reducer (P/N 0250080204). These laparoscopic manual instruments are intended for cutting, holding, grasping, and manipulating tissue and surgical auxiliaries. The devices are distributed worldwide, including in the United States and numerous international locations.
The recall is due to an 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. This documentation issue may affect the proper sterilization of the instruments.
Healthcare facilities and users should stop using the affected products and contact Stryker Endoscopy for further instructions. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- PKG, 12.5/11MM - 5.5 REDUCER, P/N 0250080204. 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
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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