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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Feb 7, 2024 natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla ... Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a vol... Class II Natus Neurology Inc
Feb 7, 2024 TENSIVE Conductive Adhesive Gel, REF 016-401600 Natus has become aware that its third-party supplier Parker Laboratories Inc. is conducting a vol... Class II Natus Neurology Inc
Feb 1, 2018 Nicolet¿ Ambulatory EEG Potential to be able to import an ambulatory exam for a patient for which the exam was not started. Class II Natus Neurology Inc
Jun 9, 2017 Nicolet¿ Elite¿ 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW... Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive backgr... Class II Natus Neurology Inc
Jun 9, 2017 Nicolet¿ Elite¿ 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. ... Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive backgr... Class II Natus Neurology Inc
Jun 9, 2017 Nicolet¿ Elite¿ 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog C... Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive backgr... Class II Natus Neurology Inc
Jun 9, 2017 Nicolet¿ Elite¿ 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Inten... Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive backgr... Class II Natus Neurology Inc
Sep 11, 2015 NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne d... When using the NicoletOne v5.94 software, after exiting the impedance check function and returnin... Class II Natus Neurology Inc
Feb 27, 2013 Nicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-0154... Natus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat a... Class II Natus Neurology Incorporated

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.