Stryker Irrigator Tips Recalled for Incorrect Sterilization Temperature Instructions
Stryker Endoscopy is recalling reusable irrigator tips because the instructions listed the wrong pre-vacuum steam sterilization temperature.
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: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error regarding sterilization temperature without reporting any specific illnesses, injuries, or hospitalizations. This aligns with the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
Stryker Endoscopy is recalling 147,921 units of Stryker Irrigator Reusable Tips, specifically the Vented Tip, 5mm X 45cm Non-Reflective with 30 Degree Downward Bend At Proximal End (Manufacturer Part Number 250-070-488s2). 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 (nationwide), Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, the Philippines, the Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brazil, Romania, South Africa, Chile, Korea, and China. Users should stop using the affected tips and contact Stryker Endoscopy for instructions on how to proceed.
The recalled product
- Product
- Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30¿ Downward Bend At Proximal End. 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: 250-070-488s2
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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