Manufacturer

King Systems Corp. dba Ambu, Inc.

11 recalls in our database name King Systems Corp. dba Ambu, Inc. as the manufacturing or recalling firm.

What the numbers show

Total: 11
Critical: 0
Severe: 0
Most recent: 2024-11-06

Of the 11 recalls from King Systems Corp. dba Ambu, Inc. 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.

1–11 of 11

HighFDA (Devices)·Z-0274-2025·2024-11-06
FDA Recalls Pediatric Oropharyngeal Airway Kit for Regulatory Non-Compliance
King Systems Corp. is recalling 21,591 KING LTSD airway kits nationwide. The devices were distributed with an unauthorized indication for pediatric use that exceeds FDA regulatory authorization.
Product
KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0273-2025·2024-11-06
King LTSD Oropharyngeal Airway Recalled for Unauthorized Pediatric Use
King Systems' KING LTSD oropharyngeal airway was marketed for pediatric use but lacked the required FDA clearance for that indication. Approximately 17,925 units were distributed nationwide.
Product
KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0270-2025·2024-11-06
Laryngeal Tube Device Recalled for Unapproved Pediatric Indication
King Systems Corp. is recalling 21,939 KING LTSD laryngeal tubes nationwide because the device was marketed for pediatric use without proper FDA regulatory clearance. The device was originally approved only for adult use.
Product
KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0275-2025·2024-11-06
King LTSD Oropharyngeal Airway Recalled for Uncleared Pediatric Indication
King Systems is recalling the King LTSD Size 2 oropharyngeal airway because it was distributed with a pediatric indication that lacks proper FDA 510(k) clearance, exceeding exemption limits.
Product
KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0269-2025·2024-11-06
AMBU King LTSD Oropharyngeal Airway Recalled for Unauthorized Pediatric Indication
King Systems Corp. is recalling AMBU King LTSD oropharyngeal airways because they were marketed for pediatric use without FDA clearance for that indication. The device exceeded its 510(k) exemption limitations.
Product
AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0272-2025·2024-11-06
King LTSD Oropharyngeal Airway Recalled for Pediatric Indication Limitation
King Systems Corp. is recalling 31,457 units of King LTSD oropharyngeal airways because the device exceeded 510(k) exemption limitations by introducing a new pediatric indication.
Product
KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0271-2025·2024-11-06
King LTSD Oropharyngeal Airway Recalled for Pediatric Indication Exemption
King Systems Corp. dba Ambu, Inc. is recalling 42,605 units of King LTSD Oropharyngeal Airways due to exceeding 510(k) exemption limitations.
Product
KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0276-2025·2024-11-06
KING LTSD Oropharyngeal Airway Kit Recalled for Unapproved Pediatric Use
King Systems Corp. is recalling KING LTSD airway kits (Model KKLTSD4325) because they were marketed for pediatric use without FDA approval for that indication. Approximately 36,727 units were distributed nationwide.
Product
KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0916-2020·2020-02-12
King Vision Video Adapter Recalled for Reversed Image Display
King Systems Corp. is recalling King Vision Video Adapters because the display shows a reversed image, causing left and right actions to be inverted.
Product
King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the placement of a tracheal tube. Model Number: KVLVA12
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1681-2019·2019-06-05
King LTS-D Kit Size 1 Recalled for Incorrect Packaging and Labeling
King Systems Corp. dba Ambu, Inc. is recalling 270 King LTS-D Kit Size 1 units because they were incorrectly packaged and labeled as size 1 products.
Product
King LTS-D Kit Size 1, Model Number KLTSD431
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0321-2018·2018-01-17
Ambu Universal Flex2 Breathing Circuits Recalled for Leak Test Failures
King Systems Corp. dba Ambu, Inc. is recalling 871,116 Universal Flex2 Breathing Circuits due to potential leak test failures.
Product
UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z, DF370-6121Z, DF3110-61Z, DF375-17621Z, DF375-6121Z, DF475-
Category
Medical Device
Distribution
43 states