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: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no specific injuries or illnesses are reported in the source text. The hazard is a labeling error regarding sterilization temperatures.
Plain-English summary
Stryker Endoscopy is recalling Stryker Irrigator Reusable Tips (3mm X 32cm Regular Tip, Non-Vented, Metal Finish) due to an error in the Instructions for Use. The product is used to aid in cleaning and clearing the operative site during laparoscopic surgery.
The recall was initiated because the pre-vacuum steam sterilization (wrapped method) temperature was incorrectly listed as 121-123°C, instead of the correct 132-133°C. This labeling error could affect the proper sterilization of the device.
The recall involves 147,921 units of all sizes. The products were distributed worldwide, including the USA (nationwide) and countries such as Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Philippines, Netherlands, France, Australia, Canada, Japan, Scandinavia, Iberia, Brazil, Romania, South Africa, Chile, Korea, and China. Users should stop using the product and contact Stryker Endoscopy for instructions.
The recalled product
- Product
- Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-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: 250-070-491
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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