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Vehicle Safety

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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Browse Device Recalls

1,646 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,646 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 1,646 FDA device recalls in MN.

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DateProductReasonClassFirm
Jul 31, 2015 AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized ... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation
Jul 31, 2015 AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog N... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation
Jul 31, 2015 AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, S... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation
Jul 24, 2015 Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to... EOPA Arterial Cannula Devices in this lot were shipped without the guidewire. Class II Medtronic Perfusion Systems
Jul 17, 2015 LYFO Disk LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Cat... Class III Microbiologics Inc
Jun 25, 2015 Aequalis Humeral Nail Targeting Jig, Product Code: 9020060. Orthopedic man... Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports ... Class II Tornier, Inc
Jun 16, 2015 Celsite Implantable Access Port System, model ST301. The Celsite Implantable... The manufacturer, B. Braun medical France, received endotoxin test results that are out of specif... Class II B. Braun Interventional Systems
Jun 15, 2015 Block Versions Used by Dental Offices often referred to as chairside milling:... 3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate produc... Class II 3M Company - Health Care Business
Jun 12, 2015 Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and D... Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports ... Class II Medtronic Perfusion Systems
May 26, 2015 CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Versio... Smiths Medical has become aware of an issue with an intermittent occurrence of binding of the loc... Class II Smiths Medical ASD, Inc.
May 2, 2015 Synovis VASCU-GUARD Peripheral Vascular Patch in the following sizes and prod... Baxter healthcare is recalling specific product codes of Vascu-Guard Peripheral Vascular Patch du... Class I Synovis Surgical Innovations, Inc.
Apr 29, 2015 LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care setti... The barometric pressure measurement output of this particular IRMA TRUPoint SN 443914 device will... Class II LifeHealth, LLC
Apr 16, 2015 Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 370... Medtronic is providing Important information regarding extension handling during implant procedur... Class II Medtronic Neuromodulation
Apr 10, 2015 Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-4... Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II ... Class II Medtronic Neuromodulation
Apr 9, 2015 Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/5... Several lots of the 9.5 mm Genesis Malleable Penile Prosthesis were mislabeled. The Retail Box an... Class II Coloplast Manufacturing US, LLC
Mar 23, 2015 Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx ... Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Periphe... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Mar 21, 2015 Smiths Medical, BCI Advisor Vital Signs Monitor, Product Reorder No 92M774325A. The Auxiliary Serial Input/ Output Modes on the Advisor do not function as expected, resulting in... Class II Smiths Medical ASD, Inc.
Mar 19, 2015 Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable... A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-... Class II Incisive Surgical Inc
Mar 17, 2015 Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product... Possible performance issue when used with specific AA-sized (LR6) batteries. The negative termina... Class II Medtronic Inc. Cardiac Rhythm Disease Management
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

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.