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Browse Device Recalls

7 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 7 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 7 FDA device recalls.

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DateProductReasonClassFirm
Jun 18, 2025 Natus Brain Monitor Breakout Box, Part Number 021911; full-montage standard e... Natus received two complaints of left side labeling show impedance for right side. Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
May 7, 2025 Brand Name: OBM00002 OBM DAB (Digital Acquisition Box) Product Name: OBM0000... Electrode placement labels on the Digital Acquisition Box (DAB) were applied backwards. This may ... Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Dec 2, 2021 IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neur... Tile kits that allow one to install and situate a video camera within a patient environment are n... Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Mar 5, 2020 natus newborn care Olympic Brainz Monitor, REF OBM00002. electroencephalograph The OBM system functional test (impedance and noise) was not carried out on the affected items pr... Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
May 18, 2018 Natus Neurology ErgoJust Carts labeled as the following: ICU Cart Export For ... Natus Neuro has discovered a possible manufacturing defect in the ErgoJust mobile cart that may c... Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
May 15, 2018 XLTEK EMU40EX EEG Headbox Possible degradation of an internal electronic component over time which may cause the XLTEK EMU ... Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
Nov 11, 2015 Natus Quantum System with NeuroWorks Software. Catalog /Part Numbers: 013926.... During an internal testing, Natus Medical Incorporated, identified that in Neuro Works 8.1 with Q... Class II Natus Neurology DBA Excel Tech., Ltd. (XLTEK)

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.