Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions
Stryker Endoscopy is recalling reusable irrigator tips because the instructions for use listed incorrect pre-vacuum steam sterilization temperatures.
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 describes a labeling error regarding sterilization temperatures without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
Stryker Endoscopy is recalling Stryker Irrigator Reusable Tips, specifically the 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. These suction irrigator tips are used to aid in cleaning and clearing the operative site during laparoscopic surgery. The recall involves 147,921 units of all sizes.
The recall was initiated because the pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use was incorrectly listed as 121-123°C, instead of the correct 132-133°C. This labeling error could potentially affect the proper sterilization of the devices.
The affected products were distributed worldwide, including in the United States (nationwide) and numerous international locations such as Mexico, Canada, Australia, and various countries in Europe, Asia, and South America. Healthcare facilities and users should verify their inventory against the manufacturer part number 250-070-484 and follow the recall instructions provided by Stryker Endoscopy.
The recalled product
- Product
- Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
- Manufacturer
- Stryker Endoscopy
- Hazard
- Affected units
- 147,921
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)
- Manufacturer Part Number: 250-070-484
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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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