Steris Quick Connects Recalled Due to Hysteroscope Port Mismatch
Steris Corporation is recalling 809 Quick Connect flow units because processing instructions incorrectly list a hysteroscope model with two inlet ports when the device has only one.
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 indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling/instruction error regarding port configuration, which is a moderate risk.
Plain-English summary
Steris Corporation is recalling 809 units of Quick Connects, model numbers QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. These flow units, which consist of tubing, tethers, and adapters, are used for sterilant and rinse water in endoscope washers. The recall covers all lots of these specific models.
The recall was initiated because the firm discovered that one of the hysteroscope models listed for processing in four existing Quick Connects has one inlet port, whereas the Quick Connect processing instructions indicate that the model has two inlet ports. This discrepancy could lead to improper processing of the medical device.
The affected products were distributed worldwide, including in the United States, Australia, Bahrain, Bulgaria, Canada, Greece, Italy, Malaysia, Mexico, Qatar, Russia, Spain, and the United Kingdom. Users should stop using the affected Quick Connects and contact Steris Corporation for further instructions.
The recalled product
- Product
- Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC1737E, and QKC1737INT. Each Quick Connect contains a flow unit consisting of tubing, tethers, and adapters. For sterilant and rinse water used in endoscope washers.
- Manufacturer
- Steris Corporation
- Affected units
- 809
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 (4)
- All Lots. Model numbers: QKC1736E
- QKC1736INT
- QKC1737E
- and QKC1737INT.
Distribution
Distributed nationwide across the United States.
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