Browse Device Recalls

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

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DateProductReasonClassFirm
Jan 9, 2015 NAMIC Convenience Kit, UPN H749601314811, REF/Catalog No. 60131481, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749601801561, REF/Catalog No. 60180156, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749601399921, REF/Catalog No. 60139992, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, NEURO ANGIO KIT, UPN H749600202361, REF/Catalog No. 60... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H965600338021, REF/Catalog No. 60033802, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H965600125911, REF/Catalog No. 600... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, 3V MANIFOLD KIT, UPN H965601011621, REF/Catalog No. 60... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, ANGIO KIT, UPN H749601319961, REF/Catalog No. 60131996... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749600329421, REF/Catalog No. 60032942, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601605351, REF/Catalog No. 601... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600618011, REF/Catalog No. 600... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601506721, REF/Catalog No. 601... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H7496005216131, REF/Catalog No. 600521613, STERILE... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT/RIGHT HEART KIT, UPN H7496008010201, REF/Catalog ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, PTCA KIT, UPN H9656019110161, REF/Catalog No. 60191101... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART, UPN H7496006044121, REF/Catalog No. 600604... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H965601955411, REF/Catalog No. 60195541, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749606204751, REF/Catalog No. 60620475, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749601617931, REF/Catalog No. 601... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H965607011741, REF/Catalog No. 60701174, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749601827221, REF/Catalog No. 60182722, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602322341, REF/Catalog No. 602... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, ANGIO DOUBLE SPIKE KIT, UPN H9656003028111, REF/Catalo... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749600203741, REF/Catalog No. 60020374, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H7496016046121, REF/Catalog No. 601604612, STERILE... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, 5 VALVE MANIFOLD KIT, UPN H749600105121, REF/Catalog N... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, MOBILE CATH LAB KIT, UPN H749600419211, REF/Catalog No... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H7496007057101, REF/Catalog No. 60... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H7496013148131, REF/Catalog No. 601314813, STERILE... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749602001451, REF/Catalog No. 60200145, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749601308341, REF/Catalog No. 60130834, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, 3V WMMII KIT, UPN H965601852521, REF/Catalog No. 60185... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, 3 VALVE KIT CARDIOVASCULAR PROCEDURE KIT, UPN H7496004... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749602301481, REF/Catalog No. 60230148, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749602207461, REF/Catalog No. 602... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable de... Current labeling indicates that cycling improves device longevity in every programming scenario. ... Class II Medtronic Neuromodulation
Jan 9, 2015 Hudson RCI, Sheridan, Preformed Tracheal Tubes, Cuffed and Uncuffed, Rx Only,... Labeling; The affected product packaging is incorrectly labeled as being a cuffed oral ET tube; T... Class II Teleflex Medical
Jan 9, 2015 NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749600617521, REF/Catalog No. 6006... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, LEFT HEART KIT, UPN H749600407061, REF/Catalog No. 600... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H965601931651, REF/Catalog No. 60193165, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, UPN H749601904231, REF/Catalog No. 60190423, STERILE, ... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, RADIOLOGY KIT, UPN H749601506921, REF/Catalog No. 6015... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, RADIOLOGY KIT, UPN H7496002072111, REF/Catalog No. 600... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 9, 2015 NAMIC Convenience Kit, 3 VALVE KIT, UPN H749600709971, REF/Catalog No. 600709... The labelled expiration dating of the affected product is not fully supported by shelf life verif... Class II Navilyst Medical, Inc
Jan 5, 2015 ARROW Epidural Needle Component (product number AN-05501). Epidural needles ... The product labeling does not specify the 5 year shelf life of the product. Class II Arrow International Inc
Dec 29, 2014 Fitness Gear Inversion table (Style STE00059FG or Style STE00118FG), Distribu... Reports of customers falling from the Inversion Table and sustaining injuries. The Inversion Tabl... Class II Dick's Sporting Goods
Dec 29, 2014 Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Cap... Self-Righting Luer Tip Caps were manufactured and shipped with a missing latex symbol on both sin... Class II Baxter Corporation Englewood
Dec 22, 2014 SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA ... The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new f... Class II Vitrolife Inc
Dec 22, 2014 Flyte Togas are components of the Stryker Flyte System and are intended to be... A single lot (11121171) of Flyte Toga Peel-away X-Large (catalog number 0408-830-100) was labeled... Class III Stryker Instruments Div. of Stryker Corporation
Dec 19, 2014 Synthes Electric Pen Drive (EPD) System, The Synthes Electric Pen Drive is in... In May 2013, the original recall was initiated due to complaints the Hand Switch for the Electric... Class II Synthes, 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.