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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

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DateProductReasonClassFirm
Feb 12, 2024 Curaplex Nasal Intubation Kit with 6mm Endotrol Tube-To perform a nasal intub... Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation proce... Class II Sarnova HC, Llc
Feb 12, 2024 Curaplex Nasal Intubation Kit w/ 7mm Endotracheal Tube-To perform a nasal int... Endotracheal Tube Holder included in certain kits is not compatible with a nasal intubation proce... Class II Sarnova HC, Llc
Nov 6, 2023 Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides he... It was determined that the Endotracheal Tube Holder included in certain kits is not compatible wi... Class II Sarnova HC, Llc
Nov 6, 2023 Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Ite... It was determined that the Endotracheal Tube Holder included in certain kits is not compatible wi... Class II Sarnova HC, Llc
Jul 11, 2018 POM Procedural Oxygen Masks, Endoscopic, Conscious Sedation, Bronchoscopy Mas... Complaints were received on the product, such as the re-breather bag would not fill/inflate or th... Class II POM Medical LLC

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.