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Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

1,677 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,677 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 1,677 FDA device recalls in MN.

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DateProductReasonClassFirm
Mar 16, 2015 DiaSorin, PRO-Trac II Tacrolimus ELISA kit, REF 32400 and 32400-CN. Product ... Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient resu... Class II Diasorin Inc.
Mar 4, 2015 Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. ... The OAD saline sheath outer layer may flake off from the catheter due to friction between the out... Class I Cardiovascular Systems, Inc.
Feb 25, 2015 Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainag... Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL ... Class II Boston Scientific Corporation
Feb 25, 2015 Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Ca... Complaints of device fragmentation after the catheter was implanted in the biliary system. The mo... Class II Boston Scientific Corporation
Feb 23, 2015 Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath... Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end ... Class I Medtronic Inc. Cardiac Rhythm Disease Management
Feb 2, 2015 CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Ster... Smiths Medical has become aware of an issue with specific lots of 50mL CADD" Medication Cassette ... Class II Smiths Medical ASD, 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
Dec 23, 2014 Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). ... This recall has been initiated because use of the impacted DPIs could result in erroneous testing... Class II Shape Medical Systems, 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 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.
Nov 25, 2014 TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequen... A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath cath... Class II St Jude Medical
Nov 25, 2014 SenSmart, Regional Oximetry EQUANOX Classic Plus Adult/Pediatric Sensor > 4... Nonin Medical is conducting a recall of certain regional oximetry sensors and associated product... Class II Nonin Medical, Inc
Nov 21, 2014 DrugCheck Ketamine Dip Test 31317-3P PRO-EU-SWE, 31226-3-CA-GML, 30842 TR, 3... This recall has been initiated due to potential false positives results when using the test to sc... Class II Express Diagnostics Int'l., Inc.
Oct 31, 2014 The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bi... Medtronic initiated an Urgent Medical Device Recall for 66 distributed Affinity FusionTM Oxygenat... Class II Medtronic Perfusion Systems
Oct 15, 2014 AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS M... During routine periodic packaging testing, AMS identified that in simulated extreme shipping and ... Class II American Medical Systems, Inc.
Oct 15, 2014 AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF... During routine periodic packaging testing, AMS identified that in simulated extreme shipping and ... Class II American Medical Systems, Inc.
Oct 14, 2014 St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, St... St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" H... Class II St Jude Medical
Oct 14, 2014 St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Mo... St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Re... Class II St Jude Medical
Oct 10, 2014 AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Acces... AMS' supplier has issued a recall of certain lots of Lightning Bolt Keith needles supplied in AMS... Class II American Medical Systems, Inc.
Oct 6, 2014 LYFO-DISK, Quality control kit for culture media, sold as: LYFO-DISK Ente... This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Syner... Class II Microbiologics Inc
Oct 6, 2014 KWIK-STIK, Quality control kit for culture media, sold as: a. KWIK-STIK 2... This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Syner... Class II Microbiologics Inc
Oct 6, 2014 KWIK-STIK, Quality control kit for culture media, sold as: KWIK-STIK (sin... This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Syner... Class II Microbiologics Inc
Oct 3, 2014 SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP4... Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser d... Class II Monteris Medical Corp
Oct 3, 2014 FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DT... Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser d... Class II Monteris Medical Corp
Oct 1, 2014 IMRIS Operating Room table (ORT200 and ORT300). Intended for use during di... One of the three pins that is used to hold the ORT200 table alignment block in place on the floor... Class II IMRIS Inc
Sep 29, 2014 CADD-Solis Medication Safety Software, Administrator CD, Version 3.1, REF 21-... Smiths Medical has identified an issue with a single batch (Lot Number 2752712) of CADD&quot... Class II Smiths Medical ASD, Inc.
Sep 29, 2014 Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5... Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam whe... Class II Coloplast Manufacturing US, LLC
Sep 24, 2014 Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters... Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an ... Class II STERILMED, INC.
Sep 17, 2014 Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11... Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ... Class II Boston Scientific CRM Corp
Sep 17, 2014 Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... Boston Scientific identified a subset of COGNISTM CRT-Ds and TELIGENTM ICDs that had experienced ... Class II Boston Scientific CRM Corp
Sep 8, 2014 Biatain Super Non-Adhesive, Catalog number 46300, 10 pcs, REF 0463001400. Cou... Coloplast is conducting a recall for one lot (4201931) of the Biatain Super Non-Adhesive wound d... Class III Coloplast Manufacturing US, LLC
Aug 27, 2014 GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS... Due to an anomaly in the packaging process, it is possible that a defective seal could be present... Class II Gyrus Medical, Inc
Aug 8, 2014 CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is desig... CareFusion has identified a potential for damage to the power connector on the EnVe and ReVel ven... Class I CareFusion 203, Inc.
Jul 14, 2014 Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, S... Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potent... Class II Medtronic Neuromodulation
Jul 11, 2014 Medtronic Ascenda Intrathecal Catheter models 8780 and 8781, and Ascenda Intr... Medtronic is removing specific lots of the Ascenda Intrathecal Catheters and Revision Kits, which... Class II Medtronic Neuromodulation
Jul 8, 2014 Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a ... Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have been sold as a stand-alone non... Class II Gyrus Medical, Inc
Jun 20, 2014 LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO. L... Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a s... Class II Laser Peripherals LLC
Jun 19, 2014 Boston Scientific ENDOTAK RELIANCE¿ SG, transvenous defibrillation lead, Mode... A review of manufacturing test records for Boston Scientific ENDOTAK RELIANCE implantable leads ... Class II Boston Scientific CRM Corp
Jun 11, 2014 Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. F... Potential for misalignment of the Z-stage scale. Using one of these devices for a procedure could... Class II Medtronic Neuromodulation
Jun 9, 2014 3M Attest Auto-reader. Model numbers 390, 390G,and 490. These device... Labeling on units shipped prior to May 16th, 2014 did not contain the statement "This product con... Class II 3M Company - Health Care Business
Jun 4, 2014 Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unic... Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Me... Class II Blue Belt Technologies MN
Jun 4, 2014 Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unic... Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Me... Class II Blue Belt Technologies MN
May 28, 2014 Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 00... Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Car... Class II Shape Medical Systems, Inc
May 27, 2014 Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions... The inner catheter of some Langston V2 Dual Lumen Catheters have separated from the device hub du... Class I Vascular Solutions, Inc.
May 23, 2014 CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherect... CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because i... Class I Cardiovascular Systems, Inc.
May 12, 2014 Armstrong Grommet with wire Otological Ventilation Tube Catalog #: VT-0507-... One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventil... Class II Summit Medical, Inc.
May 2, 2014 Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtron... Medtronic has determined that an Ascenda catheter kit may have had endotoxin in excess of USP lim... Class II Medtronic Neuromodulation
Apr 29, 2014 Medtronic Temporary Pacemaker, Model 5348. Single Chamber External Pulse Gene... Events related to a pacing rate outside of the intended setting, including events of sudden incre... Class II Medtronic Inc. Cardiac Rhythm Disease Management

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.