The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0425-2013·Announced 2012-11-28

King Systems Recalls Infant Laryngeal Airway Devices Due to Sterilization Indicator Issues

King Systems Corp. is recalling 2,630 infant laryngeal airway devices because sterilization indicators failed to change color as expected, raising concerns about proper ethylene oxide sterilization.

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 or significant injuries, fitting the criteria for a moderate severity score involving potential but unconfirmed health risks.

Plain-English summary

King Systems Corp. is recalling 2,630 units of KING LAD Standard ClearSeal SINGLE USE laryngeal airway devices, specifically Size 2 / Infant (Patient Size: 10-20kg). The recall involves 263 cases of product, identified by REF: LAD-902 and Lot #K120414. These devices are intended for single-use laryngeal airway management and are distributed nationwide in the US, including in Wisconsin, Texas, New York, Missouri, Indiana, Kentucky, Florida, New Jersey, Pennsylvania, Tennessee, and North Carolina.

The recall was initiated after the firm received two complaints from a user facility in New Jersey. The complaints reported that the color-coded ethylene oxide (EtO) sterilization indicators on the primary device packaging did not undergo the expected color change. Specifically, the indicators remained pink, whereas the product packaging specifies that the color should change from pink to yellow (or brown) if the product has been subjected to EtO sterilization. This discrepancy raises concerns that the devices may not have been properly sterilized.

Healthcare facilities and consumers who have these specific devices should stop using them immediately. Users should contact King Systems Corp. for further instructions on how to return or dispose of the affected products. The agency has classified this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
Manufacturer
King Systems Corp.
Category
Medical Device — Airway Management
Hazard

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-902
  • Lot #K120414

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

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.

See all 10 products in this recall →

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