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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
May 19, 2025 Brand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - ... Product packaging contains the wrong part number and kit contents. Class II Neurovision Medical Products Inc
Jul 1, 2024 Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubb... mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. Class II Neurovision Medical Products Inc
Jul 21, 2020 Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI:... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMT ET Tube, 7.0mm REF: NVTKI... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Cobra x5 2-Ch EMG ET Tube, 6.0mm, REF: LTE700DCS-5, Rx Only, Sterile EO UDI:... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Cobra x5 1-Ch EMG ET Tube, 8.0mm, REF: LTE700L-5, Rx Only, Sterile EO UDI: ... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: ... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: ... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI:... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products Inc
Jul 21, 2020 Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKI... The electrode insulating material on the Cobra EMG ET tube used for continuous EMG monitoring may... Class II Neurovision Medical Products 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.