King Systems Recalls Adult Silicone King LAD Devices Due to Sterilization Indicator Issues
King Systems Corp. is recalling specific lots of adult silicone King LAD devices because sterilization indicators failed to change color as expected.
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 does not report any hospitalizations, injuries, or illnesses. The hazard is a potential failure of the sterilization indicator, which is a labeling/packaging verification issue rather than a confirmed contamination or structural defect causing harm.
Plain-English summary
King Systems Corp. is recalling 263 cases (2,630 devices) of King LAD SILI CONE SINGLE USE, Size 5 / Adult Silicone King LAD. The affected products are identified by REF: LAD-305, Lot #K120620, and Lot #K120406. These devices are intended for laryngeal airway management in patients weighing over 70kg.
The recall was initiated after the firm received two complaints from a user facility in New Jersey. The complaints reported that the color-coded EtO sterilization indicators on the primary device packaging did not undergo the expected color change. Specifically, the indicators remained pink, whereas the packaging specifies they should change from pink to yellow or brown if the product was subjected to Ethylene Oxide (EtO) sterilization.
The affected products were distributed nationwide in the United States, specifically in Wisconsin, Texas, New York, Missouri, Indiana, Kentucky, Florida, New Jersey, Pennsylvania, Tennessee, and North Carolina. Users should check their inventory for the specific lot numbers and reference codes listed above. If the product matches the recalled description, it should be removed from service and returned to the manufacturer or disposed of according to facility policy.
The recalled product
- Product
- KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
- Manufacturer
- King Systems Corp.
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 (2)
- REF: LAD-305
- Lot #K120620 and Lot #K120406
Distribution
Part of a larger recall action
This product is one of 10 recalled by King Systems Corp. 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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