Manufacturer

King Systems Corp.

15 recalls in our database name King Systems Corp. as the manufacturing or recalling firm.

What the numbers show

Total: 15
Critical: 0
Severe: 0
Most recent: 2015-04-08

Of the 15 recalls from King Systems Corp. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–15 of 15

ModerateFDA (Devices)·Z-1361-2015·2015-04-08
King Systems Double Swivel Connector Recalled for Mislabeling
King Systems Corp. is recalling 900 units of Double Swivel Connectors mislabeled as having a suction port. The error may cause a short procedure delay but poses no risk to patients.
Product
Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with suct
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0709-2014·2014-01-22
King Systems Recalls Supraglottic Airway Kits Due to Incorrect Component
King Systems Corp. is recalling King LTSD Kit Size 4 supraglottic airway devices because some packages contained KLTD214 airways that lack a required gastric suction tube lumen.
Product
King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part Number(s): KLTSD414 KING LTSD KIT/KIT/TROUSSE/KIT SIZE 4 Contents: 1 - KLTSD Size 4......(155 - 180cm) .. 1 - 60cc Syringe 1 - Sterile Lubri
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2272-2013·2013-10-09
King Systems Universal Flex2 Breathing Circuit Recalled for Latex Mislabeling
King Systems Corp. is recalling Universal Flex2 Breathing Circuits that contain latex bags but are labeled as non-latex.
Product
Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-p
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0002-2014·2013-10-09
King Systems Recalls Mislabelled Oropharyngeal Airways Due to Size Error
King Systems Corp. is voluntarily recalling one case of King LTS-D Oropharyngeal Airways because the package label incorrectly identified the size.
Product
King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspirati
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2255-2013·2013-09-25
King LT-D Oropharyngeal Airways Recalled for Packaging Labeling Error
King Systems Corp. is recalling King LT-D Oropharyngeal Airways because size 5 units were packaged in pouches labeled as size 2.5.
Product
King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach conten
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0422-2013·2012-11-28
King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Issues
King Systems Corp. is recalling specific lots of KING LAD Standard ClearSeal laryngeal airway devices because the ethylene oxide sterilization indicators did not change color as expected.
Product
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0424-2013·2012-11-28
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.
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0423-2013·2012-11-28
King Systems Recalls Laryngeal Airway Devices Due to Sterilization Indicator Failure
King Systems Corp. is recalling 2,630 laryngeal airway devices because sterilization indicators failed to change color, suggesting the devices may not be sterile.
Product
KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult ClearSeal King LAD¿ Patient Size: 50-70kg Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0419-2013·2012-11-28
King Systems Recalls Child Silicone Laryngeal Airway Devices Due to Sterilization Indicator Defect
King Systems Corp. is recalling 2,630 child silicone laryngeal airway devices because sterilization indicators failed to change color as expected, raising concerns about proper EtO sterilization.
Product
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0418-2013·2012-11-28
King Systems Recalls Infant Silicone Laryngeal Airway Devices
King Systems Corp. is recalling 2,630 infant silicone laryngeal airway devices due to potential EtO sterilization indicator failures.
Product
KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0420-2013·2012-11-28
King Systems Recalls Adult Silicone King LAD Devices Due to Sterilization Indicator Issues
King Systems Corp. is recalling 2,630 adult silicone King LAD devices because sterilization indicators failed to change color as expected.
Product
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone King LAD¿ Patient Size: 50-70kg
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0427-2013·2012-11-28
King Systems Recalls Flexible ClearSeal Laryngeal Airway Devices
King Systems Corp. is recalling 2,630 Flexible ClearSeal Laryngeal Airway Devices due to EtO sterilization indicators that failed to change color.
Product
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0426-2013·2012-11-28
King Systems Recalls Flexible ClearSeal Laryngeal Airway Devices
King Systems Corp. is recalling 2,630 Flexible ClearSeal Laryngeal Airway Devices due to sterilization indicators that failed to change color as expected.
Product
KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child ClearSeal Flexible King LAD¿ Patient Size: 30-50kg " Product Usage: Laryngeal airway
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0421-2013·2012-11-28
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.
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0425-2013·2012-11-28
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.
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
Category
Medical Device
Distribution
Distributed nationwide