Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature 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, but the source text describes a labeling error regarding sterilization temperatures without reporting any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Endoscopy is recalling 147,921 units of Stryker Irrigator Reusable Tips, specifically the 5mm X 32cm Hydrodissection Tip with a non-reflective finish. These suction irrigator tips are used to clean and clear the operative site during laparoscopic surgery.
The recall was initiated because the Instructions for Use incorrectly listed the pre-vacuum steam sterilization (wrapped method) temperature as 121-123°C, rather than the correct 132-133°C. This labeling error could result in improper sterilization of the devices.
The affected products were distributed worldwide, including in the United States and numerous international markets such as Canada, Mexico, and countries in Europe, Asia, and South America. Healthcare facilities should verify their inventory against the manufacturer part number 250-070-487 and follow the recall instructions provided by Stryker Endoscopy.
The recalled product
- Product
- Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective 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: 250-070-487
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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