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.
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: This is a Class II recall involving a labeling error that could lead to improper sterilization, but no injuries or illnesses have been reported.
Plain-English summary
Stryker Endoscopy is recalling Stryker Irrigator Reusable Tips (5mm X 45cm Regular Tip, Vented, Metal Finish) due to a labeling error in the Instructions for Use. The instructions incorrectly listed the pre-vacuum steam sterilization (wrapped method) temperature as 121-123°C, whereas the correct temperature is 132-133°C.
The affected units are manufacturer part number 250-070-408. The recall covers 147,921 units of all sizes. These products were distributed worldwide, including the United States, Mexico, Canada, and various countries in Europe, Asia, and South America.
Healthcare facilities should stop using the affected irrigator tips and contact Stryker Endoscopy for instructions on how to proceed. The error in the instructions could lead to improper sterilization if followed, potentially compromising the safety of the device during laparoscopic surgery.
The recalled product
- Product
- Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, 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: 250-070-408.
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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