Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

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

Infrastructure

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

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

Browse Device Recalls

3,013 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,013 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 3,013 FDA device recalls in 2018.

Clear
DateProductReasonClassFirm
May 7, 2018 PROLENE SUTURE BLUE 18" 7-0 D/A BV-1, DC631 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 PROLENE SUTURE MONO BLUE - BV1755 Taper Point 3/8C, D10031 The needle associated with certain suture product codes has the potential to perforate the packag... Class II Ethicon, Inc.
May 7, 2018 WaveCrest Left Atrial Appendage (LAA), Occlusion System (32 mm), Catalog Numb... When attempting to recapture the 32-mm device, the tip of the delivery sheath may fold or buckle,... Class I Biosense Webster, Inc.
May 5, 2018 VITROS Sodium Slides, Catalog # 837 9034 Potential for positively biased results Class II Ortho-Clinical Diagnostics
May 4, 2018 smith&nephew GENESIS(R) II TIBIAL Punch, 13 MM, REF 71440408, QTY: (1) One lot of GENESIS II 13 mm tibial punches are 2 mm smaller than specification. Class II Smith & Nephew, Inc.
May 4, 2018 MicroScan Pos Combo Panel Type 43, Catalog number B1017-217for use in determi... The drug dilution sequence for Moxifloxacin printed on the panel is incorrect. As a result, incor... Class II Beckman Coulter Inc.
May 4, 2018 Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used... The adapter may demonstrate a degradation of function as the final products were assembled with b... Class II Synthes (USA) Products LLC
May 4, 2018 remel SUPERPACK CS/ 500 SEG/FLASK, REF R01626, Qty:50, plate label: REMEL MH ... Product may fail performance testing for S aureus ATCC 43300. Class II Thermo Fisher
May 4, 2018 Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463 Laser etching which indicates whether the device is in compression or distraction mode appears ... Class II Stryker GmbH
May 4, 2018 Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9c... The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a p... Class II Vascular Solutions, Inc.
May 4, 2018 RX Imola (RX4900) For Professional Use for the quantitative in vitro deter... Abnormal premature termination of the software could affect the use of the analyser when running ... Class II Randox Laboratories
May 3, 2018 Medtronic Clip Gun Magazines are packaged in individually sealed pouches and ... The packaging sterile barrier does not comply with the applicable packaging standard for terminal... Class II Medtronic Neurosurgery
May 3, 2018 HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length ... The devices may have been assembled with an internal component that may cause continuous or inadv... Class II Ethicon Endo-Surgery Inc
May 3, 2018 ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROC... Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattr... Class II Joerns Healthcare
May 3, 2018 P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP36... Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattr... Class II Joerns Healthcare
May 3, 2018 HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (8612... The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may... Class II Philips Electronics North America Corporation
May 3, 2018 CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP), Part Number 0998-00-0800-... Ingress of fluids into the device can affect various electronic circuit boards which would preven... Class I Maquet Datascope Corp - Cardiac Assist Division
May 3, 2018 HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length ... The devices may have been assembled with an internal component that may cause continuous or inadv... Class II Ethicon Endo-Surgery Inc
May 2, 2018 1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilat... The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... Class II Galt Medical Corporation
May 2, 2018 TVS LPA, Catalog #: DIL-059-00 The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... Class II Galt Medical Corporation
May 2, 2018 Part #: SAM XT-C, Model: Hi-Viz Orange or Civilian Based on internal testing, results indicated a possible failure of the stitches securing the buck... Class II The Seaberg Company Inc
May 2, 2018 smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x... Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length.... Class II Smith & Nephew, Inc.
May 2, 2018 Heartware Medtronic HVAD System for cardiac use. Including the following pa... Possible transient electrical connection interruption between an HVAD System power source (Batter... Class I Heartware
May 2, 2018 AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N u... The diameter of the drill sleeve guide raw material was found to be under tolerance, potentially ... Class II Ad-Tech Medical Instrument Corporation
May 2, 2018 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog... The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... Class II Galt Medical Corporation
May 2, 2018 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) ... The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... Class II Galt Medical Corporation
May 2, 2018 MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24... Cross-contamination of samples has been reported when running the existing protocol on the system... Class II Roche Molecular Systems, Inc.
May 2, 2018 AXS Infinity LS Long Sheath:((6F/.088in)/ x 70cm GEN-10800-70, (6F/.088in)/ x... The AXS Infinity LS Long Sheath Dilator outer diameter (OD) specification was exceeded. Class II Stryker Neurovascular
May 2, 2018 Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; ... The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... Class II Galt Medical Corporation
May 2, 2018 Part #: SAM XT-C, Model: Hi-Viz Blue Based on internal testing, results indicated a possible failure of the stitches securing the buck... Class II The Seaberg Company Inc
May 2, 2018 Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-... The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... Class II Galt Medical Corporation
May 2, 2018 Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15, The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... Class II Galt Medical Corporation
May 2, 2018 Part #: SAM XT-M, Model: Tactical Black or Military Based on internal testing, results indicated a possible failure of the stitches securing the buck... Class II The Seaberg Company Inc
May 2, 2018 NaturaLyte¿ Liquid Acid Concentrate for Bicarbonate Dialysis, 3.43 Liters, Pa... The bottles are mislabeled with an incorrect part number. Class II Fresenius Medical Care Renal Therapies Group, LLC
May 2, 2018 1) Drainer Centesis Catheter, Sterile EO, Rx Only, Catalog #: a) DRC-001-05... The products listed might contain unsafe levels of bacterial endotoxins (Pyrogens) that were intr... Class II Galt Medical Corporation
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Artis zee floor MN, Material no. 10094142, for angiography and whole body rad... After the Large Display returns from power save mode, it may not show an image, and stay black wi... Class II Siemens Medical Solutions USA, Inc
May 1, 2018 Artis Q.zen biplane, Material no. 10848355, for angiography and whole body ra... After the Large Display returns from power save mode, it may not show an image, and stay black wi... Class II Siemens Medical Solutions USA, Inc
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Artis zee floor, Material no. 10094135, for angiography and whole body radiog... After the Large Display returns from power save mode, it may not show an image, and stay black wi... Class II Siemens Medical Solutions USA, Inc
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Artis zee ceiling, Material no. 10094137, for angiography and whole body radi... After the Large Display returns from power save mode, it may not show an image, and stay black wi... Class II Siemens Medical Solutions USA, Inc
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 OmniDiagnost Classic X-ray system Angiographic and Diagnostic, Product Nos. ... The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and... Class II Philips Medical Systems Nederlands
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Artis zee biplane, Material no. 10094141, for angiography and whole body radi... After the Large Display returns from power save mode, it may not show an image, and stay black wi... Class II Siemens Medical Solutions USA, Inc
May 1, 2018 Artis zee MP, Material no. 10094139, for angiography and whole body radiograp... After the Large Display returns from power save mode, it may not show an image, and stay black wi... Class II Siemens Medical Solutions USA, Inc
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 OmniDiagnost-Eleva X-ray system Angiographic and Diagnostic, Product Nos. 708... The fixation of the upper and lower tilt actuator, of the Omnidiagnost system might break off and... Class II Philips Medical Systems Nederlands

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.