Browse Device Recalls
5,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,428 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 5,428 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Dec 18, 2014 | Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This de... | Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (a... | Class II | Spinal Elements, Inc |
| Dec 17, 2014 | Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Hep... | The outer box label is marked with the correct expiration date of 08/2016. The inner Tyvek Unit L... | Class III | Smiths Medical ASD, Inc. |
| Dec 17, 2014 | Miethke Shunt System accessories Product Usage: - The Miethke Shunt Syst... | Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box lab... | Class II | Aesculap, Inc. |
| Dec 15, 2014 | Ysio Max, Luminos dRF Max and Agile Max systems with software version VE10 an... | Potential for composed images to be flipped before being sent to PACS on systems with software v... | Class II | Siemens Medical Solutions USA, Inc |
| Dec 15, 2014 | nordicTumorEx 1.0 nordicTumorEx is an image processing software package ... | An error was discovered in the interpretation of certain DICOM header tags that may lead to incor... | Class II | NordicNeuroLab AS |
| Dec 12, 2014 | R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube... | Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal... | Class II | Teleflex, Inc. |
| Dec 12, 2014 | MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product U... | Three lots of MUM-1 may not meet their labeled shelf life, as a drop in staining intensity over t... | Class II | Biocare Medical Llc |
| Dec 12, 2014 | Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro dia... | Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 ... | Class III | Pointe Scientific, Inc. |
| Dec 10, 2014 | Covidien Trellis-6 Peripheral Infusion System. Models BVT608010V01, BVT60803... | A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation por... | Class I | Covidien |
| Dec 10, 2014 | Covidien Trellis-8 Peripheral Infusion System. Models CVT808015, CVT808025, ... | A manufacturing error resulted in the risk of incorrect proximal and distal balloon inflation por... | Class I | Covidien |
| Dec 5, 2014 | INRatio Monitors - 0100004 Alere INRatio PT/INR System Professional - 01000... | In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl... | Class I | Alere San Diego, Inc. |
| Dec 5, 2014 | INRatio 2 Monitors - 0200431 Alere INRatio 2 PT/INR Professional Testing Sys... | In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl... | Class I | Alere San Diego, Inc. |
| Dec 5, 2014 | Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional ... | In certain cases, an INRatio PT/INR Monitor system may provide an INR result that is significantl... | Class I | Alere San Diego, Inc. |
| Dec 4, 2014 | ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, R... | Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922... | Class II | Ev3, Inc. |
| Dec 4, 2014 | ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, R... | Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922... | Class II | Ev3, 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.