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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 11 FDA device recalls.

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DateProductReasonClassFirm
Sep 26, 2024 KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx thr... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx ... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ph... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ph... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ph... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx thr... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Nov 5, 2019 King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visuali... Exhibiting a reversed image. Although the image may appear normal, the users actions will be reve... Class I King Systems Corp. dba Ambu, Inc.
Jan 4, 2019 King LTS-D Kit Size 1, Model Number KLTSD431 Size 0 products were incorrectly packaged and labeled as a size 1 products. Class II King Systems Corp. dba Ambu, Inc.
Mar 15, 2017 UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390... Potential for leak test failures. Class II King Systems Corp. dba Ambu, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.