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. The hazard is a labeling error regarding sterilization temperatures, which is a documentation issue rather than a direct physical defect or reported injury.
Plain-English summary
Stryker Endoscopy is recalling Stryker Irrigator Reusable Tips, including the 5mm X 28cm Regular Tip, vented, Non-Reflective Finish. These suction irrigator tips are used to aid in cleaning and clearing the operative site during laparoscopic surgery.
The recall is due to a labeling error in the Instructions for Use. The pre-vacuum steam sterilization (wrapped method) temperature was incorrectly listed as 121-123°C, instead of the correct 132-133°C. This error could result in improper sterilization of the device.
The recall affects 147,921 units of all sizes. The 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 manufacturer part number is 250-070-482. Healthcare facilities should stop using the affected tips and contact Stryker Endoscopy for instructions on how to proceed.
The recalled product
- Product
- Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective 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: 250-070-482
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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