Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions
Stryker Endoscopy is recalling reusable 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. 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 Stryker Irrigator Reusable Tips, specifically the 2mm X 32cm Regular Tip with 1 Hole, Metal 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 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 potentially affect the sterilization process if followed.
The products were distributed worldwide, including the United States (nationwide) and countries such as Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Philippines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brazil, Romania, South Africa, Chile, Korea, and China. The manufacturer part number is 250-070-471. Users should verify the sterilization instructions against the correct parameters provided by the manufacturer.
The recalled product
- Product
- Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
- Manufacturer
- Stryker Endoscopy
- 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: 250-070-471
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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