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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
Mar 22, 2016 Self-Cath¿ Pediatric Catheter Size CH 06, Product # 5044101400, Catakig # 30... Coloplast Corp. is voluntarily recalling a single lot of Self-Cath Pediatric French Size CH 06 ca... Class II Coloplast Manufacturing US, LLC
Mar 22, 2016 Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. P... Boston Scientific is recalling all models of Fetch 2 Aspiration Catheter as a result of receiving... Class I Boston Scientific Corporation
Mar 4, 2016 Guardian II Hemostasis Valve, models 8210 and 8211. The following models are... Vascular Solutions became aware of a potential problem with the click version of the Guardian II ... Class I Vascular Solutions, Inc.
Feb 23, 2016 Reveal LINQ insertable Cardiac Monitor, Model LNQ11. Monitors subcutaneous E... Medtronic has identified an issue with the sensitivity of an algorithm used in the Reveal LINQ IC... Class II Medtronic Inc.
Feb 12, 2016 Universal Clamp¿ System (IFU reference: SNA027-N-90001). Provides the stab... Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and di... Class II Zimmer Spine, Inc.
Feb 12, 2016 Instinct¿ Java¿ System (IFU reference: 046WAN0000T) . Stabilizes one or mo... Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and di... Class II Zimmer Spine, Inc.
Feb 10, 2016 Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMR... Emergency helium venting lines (i.e. quench lines) may not have been properly installed. Class II Deerfield Imaging
Feb 9, 2016 Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Eth... Medtronic Neuromodulation is initiating a voluntary removal of a single Model 8781 Ascenda" Intra... Class II Medtronic Neuromodulation
Feb 4, 2016 Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascu... Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tub... Class III Medtronic Perfusion Systems
Feb 3, 2016 Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipi... Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fix... Class II Zimmer Spine, Inc.
Feb 1, 2016 Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter... The Firm discovered that there is a design error which is traceable back to 2012 when a design ch... Class II Laserex Systems Inc.
Jan 26, 2016 Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x... The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a conne... Class II QiG Group LLC
Jan 26, 2016 Algostim LLC, Algovita External Pulse Generator, Trial Stimulator, Model 3400 The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a conne... Class II QiG Group LLC
Jan 26, 2016 Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2408 ( 3 x... The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a conne... Class II QiG Group LLC
Jan 22, 2016 3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL. 3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can... Class II 3M Company - Health Care Business
Jan 11, 2016 Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal co... Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between... Class II Medtronic Neuromodulation
Dec 21, 2015 ACIST Medical Systems, BT2000 Automated Manifold Kit (SKU 014613) and CPT20... Reports related to ingress of air into the manifold. Class II Acist Medical Systems
Dec 18, 2015 arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Ca... One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test... Class I Arkray Factory USA, Inc.
Dec 18, 2015 arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDT... One lot each of SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test... Class I Arkray Factory USA, Inc.
Dec 10, 2015 Boston Scientific, PROPONENT" MRI DR Pacemakers, REF L211. These devices ... The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it... Class II Boston Scientific Corporation
Dec 10, 2015 Boston Scientific, MRI PROPONENT" SR , REF L210 Pacemaker. These devices t... The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it... Class II Boston Scientific Corporation
Dec 3, 2015 Medfusion Model 3500 and 4000 Syringe Infusion Pumps and Medfusion 3010 and 3... There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Al... Class II Smiths Medical ASD Inc.
Dec 1, 2015 QC Sets and Panels: KWIK-STIK. Cepheid Xpert GBS QC Set (Live Culture). Sets... The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164... Class II Microbiologics Inc
Dec 1, 2015 QC Sets and Panels: KWIK-STIK Cepheid Smart GBS QC Set (Live Culture). Sets ... The Lactobacillus acidophilus negative control (item 0243 single KWIK-STIK) contained in the 8164... Class II Microbiologics Inc
Dec 1, 2015 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M... Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. Thi... Class II 3M Company - Health Care Business
Nov 25, 2015 Boston Scientific ACUITY Pro Coronary Sinus Guide Catheter, 9 Fr. Model 8104... Potential for separation of the proximal handle from the shaft. Class II Boston Scientific Corporation
Nov 19, 2015 Boston Scientific, Chariot ST-CCV Guiding Sheath, Sterilized using ethylene o... Boston Scientific is voluntarily recalling its Chariot" Guiding Sheath. To date, Boston Scientifi... Class I Boston Scientific Corporation
Nov 13, 2015 Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Steril... Sterilmed, Inc. is voluntarily recalling all unexpired Reprocessed Tourniquet Cuffs. Sterilmed ca... Class II STERILMED, INC.
Nov 9, 2015 Medtronic InSync III, model 8042, 8042B and 8042U. Implantable pulse generat... Medtronic has confirmed an issue with InSync III CRT-pacemaker devices related to long-term batte... Class II Medtronic Inc.
Oct 28, 2015 Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Ste... This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactu... Class II Medtronic Perfusion Systems
Oct 26, 2015 MiniArc Pro Single incision Sling System, Model number / Product Reference 90... The lot number on the outer carton label did not match the lot number printed on the tray label o... Class II Astora
Oct 9, 2015 RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev... Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque... Class I Boston Scientific Corporation
Oct 9, 2015 RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Dev... Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torque... Class I Boston Scientific Corporation
Sep 29, 2015 Medtronic Achieve Cables, model 990066. The sterile, single use only Electri... 64 units of Achieve Electrical Cables were shipped with a potential sterility breach. Class II Medtronic Inc.
Sep 17, 2015 Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator, (S-ICD). ... Devices shipped to US in dual-channel rather than US approved single-channel RF Telemetry communi... Class II Boston Scientific Corporation
Sep 16, 2015 BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartrid... May report values outside the published performance specifications for pH. After a certain point... Class II LifeHealth, LLC
Sep 16, 2015 CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartri... May report values outside the published performance specifications for pH. After a certain point... Class II LifeHealth, LLC
Sep 15, 2015 Medtronic Medical Device Identification Card for SureScan pacemaker patients.... Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they ha... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Sep 14, 2015 PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF... The label on the lid stock of the individual needle packages for a portion of Lot number 46262 co... Class II Smiths Medical ASD, Inc.
Sep 3, 2015 AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm... Summit Medical is recalling Doyle P/F Nasal Pack w/Airway, string 8 cm x 3 cm x 1.5 cm, Catalog #... Class II Summit Medical, Inc.
Sep 1, 2015 Medtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performin... An issue with a USB memory component contained within a subset of CryoConsoles can result in exte... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Aug 25, 2015 Boston Scientific, WATCHMAN Access System Access Sheath with Dilator, 14F S... Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, p... Class II Boston Scientific Corporation
Aug 25, 2015 Boston Scientific, WATCHMAN Left Atrial Appendage Closure Device with Deliver... Cross-threading of the hemostasis valve may occur if it is tightened with the dilator in place, p... Class II Boston Scientific Corporation
Aug 24, 2015 Zimmer, Reprocessed Zimmer Tourniquet Cuffs,34" Single Hose Single Bladder Br... Sterilmed, Inc. is recalling its reprocessed Zimmer Tourniquet Cuff, Part #ZIM60-7075-106, lot nu... Class II STERILMED, INC.
Aug 18, 2015 MEDIVATORS HEMOCOR HPH700, HPH-1400TS, HPH-1000TS. Enables the perfusionist ... Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is be... Class II Medtronic Perfusion Systems
Aug 18, 2015 Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-10... The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the ... Class II Ecolab Inc
Aug 18, 2015 MEDTRONIC PERFUSION TUBING PACKS (with potentially affected Hemoconcentrators... Hemocor High Performance Hemoconcentrators demonstrate low ultrafiltration performance that is be... Class II Medtronic Perfusion Systems
Aug 6, 2015 Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile... Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) ... Class II Tornier, Inc
Aug 3, 2015 Hemocor High Performance Hemoconcentrator, HPH700, sterilized with ethylene o... Hemoconcentrators may exhibit low ultrafiltration performance that is below product specification. Class II Medivators, Inc.
Jul 31, 2015 AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.... AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is N... Class II Boston Scientific Corporation

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.