King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Issues
King Systems Corp. is recalling specific lots of Laryngeal Airway Devices because sterilization indicators failed to change color as expected, potentially indicating improper 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where sterilization indicators failed, creating a risk of infection or harm from non-sterile equipment. This fits the 'High' severity criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
King Systems Corp. is recalling 263 cases (2,630 devices) of KING LAD Standard ClearSeal SINGLE USE laryngeal airway devices, specifically Lot #K120413. The recall was initiated after the company received two complaints from a user facility in New Jersey. The complaints reported that the ethylene oxide (EtO) sterilization indicators on the primary device packaging did not undergo the expected color change from pink to yellow or brown, which is required to confirm the product was subjected to sterilization.
The affected devices are Size 5 / Adult ClearSeal King LADs intended for patients over 70kg. The product was distributed nationwide in the United States, with specific distribution to Wisconsin, Texas, New York, Missouri, Indiana, Kentucky, Florida, New Jersey, Pennsylvania, Tennessee, and North Carolina.
Consumers and healthcare facilities should stop using the affected devices and contact King Systems Corp. for further instructions or a replacement. The devices are identified by REF: LAD-705 and Lot #K120413.
The recalled product
- Product
- KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult ClearSeal 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-705
- Lot #K120413
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.
See all 10 products in this recall →Related recalls
Same manufacturer · King Systems Corp.
See all →- ModerateKing Systems Double Swivel Connector Recalled for Mislabeling
FDA (Devices) · 2015-04-08
- HighKing Systems Recalls Supraglottic Airway Kits Due to Incorrect Component
FDA (Devices) · 2014-01-22
- SevereKing Systems Universal Flex2 Breathing Circuit Recalled for Latex Mislabeling
FDA (Devices) · 2013-10-09
- ModerateKing Systems Recalls Mislabelled Oropharyngeal Airways Due to Size Error
FDA (Devices) · 2013-10-09
- LowKing LT-D Oropharyngeal Airways Recalled for Packaging Labeling Error
FDA (Devices) · 2013-09-25
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Performance Pro Nitrile Gloves Due to Defects
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateKing LTSD Oropharyngeal Airway Recalled for Pediatric Indication Limitation
FDA (Devices) · 2024-11-06
- ModerateKing Systems Recalls Mislabelled Oropharyngeal Airways Due to Size Error
FDA (Devices) · 2013-10-09
- HighKing LTSD Oropharyngeal Airway Recalled for Uncleared Pediatric Indication
FDA (Devices) · 2024-11-06
- HighFDA Recalls Pediatric Oropharyngeal Airway Kit for Regulatory Non-Compliance
FDA (Devices) · 2024-11-06
- LowKing LT-D Oropharyngeal Airways Recalled for Packaging Labeling Error
FDA (Devices) · 2013-09-25
- HighLaryngeal Tube Device Recalled for Unapproved Pediatric Indication
FDA (Devices) · 2024-11-06