Noblesville, IN, United States
King Systems Corp. dba Ambu, Inc. recalls
4 recalls recorded since 2018, most recently on 26 September 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 26 September 2024
- Reason
- Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0269-2025, Z-0270-2025, Z-0276-2025, Z-0274-2025, Z-0275-2025, Z-0273-2025, Z-0272-2025, Z-0271-2025
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Terminated Class I Medical devices
- Recall started
- 5 November 2019
- Terminated
- 23 March 2021
- Reason
- Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions.
- Distribution
- Worldwide distribution. US Nationwide, Australia, Belgium, Bolivia, Canada, Costa Rica, Germany, Hong Kong, India, Italy, Japan, Myanmar, Poland, Spain, and UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0916-2020
- 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
Terminated Class II Medical devices
- Recall started
- 4 January 2019
- Terminated
- 20 April 2020
- Reason
- Size 0 products were incorrectly packaged and labeled as a size 1 products.
- Distribution
- The products were distributed to the following US states: CA, CT, FL, IA, IN, MD, MS, NC, PA, TX, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1681-2019
- King LTS-D Kit Size 1, Model Number KLTSD431
Terminated Class II Medical devices
- Recall started
- 15 March 2017
- Terminated
- 17 December 2018
- Reason
- Potential for leak test failures.
- Distribution
- Distribution Pattern Distributors in 44 states: Al, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WV, WI WY; International Pattern - Canada, China, Chile
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0321-2018
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.