Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions
Stryker Endoscopy is recalling 147,921 irrigator tips because the instructions 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, which typically corresponds to a moderate severity score. The hazard is a labeling error regarding sterilization temperatures, which is a documentation issue rather than a direct physical defect or reported injury.
Plain-English summary
Stryker Endoscopy is recalling 147,921 units of Stryker Irrigator Reusable Tips, specifically the 10mm X 32cm Pool Suction Tip with a metal finish. These suction irrigator tips are used to aid in cleaning and clearing the operative site during laparoscopic surgery. The recall covers units distributed worldwide, including the United States, Mexico, Canada, and various countries in Europe, Asia, and South America.
The recall was initiated because the Instructions for Use incorrectly listed the pre-vacuum steam sterilization (wrapped method) temperature as 121-123°C, instead of the correct 132-133°C. This labeling error could result in improper sterilization of the reusable tips if healthcare providers follow the provided instructions.
Healthcare facilities and users of these devices should stop using the affected tips and contact Stryker Endoscopy for further instructions on how to proceed. The manufacturer part number for the affected units is 250-070-404.
The recalled product
- Product
- Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal 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: 250-070-404.
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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