Stryker Irrigator Reusable Tips Recalled for Incorrect Sterilization Instructions
Stryker Endoscopy is recalling 147,921 reusable 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 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 Aspiration Needle Tip (Manufacturer Part Number 250-070-437). These suction irrigator tips are used to aid in cleaning and clearing 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 potentially affect the proper sterilization of the device if followed by users.
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 and users should stop using the affected tips and contact Stryker Endoscopy for further instructions.
The recalled product
- Product
- Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. 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: 250-070-437
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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