Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions
Stryker Endoscopy is recalling 147,921 irrigator tips because the instructions for use 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: The recall is classified as FDA Class II, but the source text identifies the issue as a documentation error (incorrect temperature in instructions) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Stryker Endoscopy is recalling 147,921 Stryker Irrigator Reusable Tips (5mm X 45cm Regular Tip, vented, Non-Reflective Finish) due to a labeling error in the Instructions for Use. The manufacturer part number for the affected units is 250-070-488.
The recall was initiated because the pre-vacuum steam sterilization (wrapped method) temperature was incorrectly listed as 121-123°C, rather than the correct 132-133°C. These suction irrigator tips are used to aid in cleaning and clearing the operative site during laparoscopic surgery.
The affected products were distributed worldwide, including 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. The source text does not specify specific actions for consumers or healthcare providers beyond the identification of the error.
The recalled product
- Product
- Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective 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: 250-070-488
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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