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

3,179 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,179 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 3,179 FDA device recalls.

Clear
DateProductReasonClassFirm
Apr 30, 2021 Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case,... The devices may not meet the minimum required sterility assurance level. Class II Medline Industries Inc
Apr 27, 2021 Quanta System Sterile Optical Laser Fiber, single use Product sterility is potentially compromised. Class II Quanta System, S.p.A.
Apr 27, 2021 Olympus Sterile Optical Laser Fiber, single use and reusable Product sterility is potentially compromised. Class II Quanta System, S.p.A.
Apr 27, 2021 Quanta System Sterile Optical Laser Fiber, reusable Product sterility is potentially compromised. Class II Quanta System, S.p.A.
Apr 26, 2021 REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 26, 2021 REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 26, 2021 REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 26, 2021 REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery. Sterility issues; single use devices labeled as sterile may not have been adequately sterilized Class II Meta C.G.M. Spa
Apr 23, 2021 Sapi Med sterile disposable colorectal anoscopes and proctoscopes. REF/Pro... Due to issue with product sterility. Sterilization service provider had falsified records. Class II Adler MicroMed, Inc.
Apr 21, 2021 Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f... Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... Class II INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Apr 21, 2021 Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the f... Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... Class II INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Apr 21, 2021 Semi-automatic Biopsy-Needle, ITP innotom.com, CE 0297, STERILE EO for the fo... Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequatel... Class II INNOVATIVE TOMOGRAPHY PRODUCT GMBH
Mar 23, 2021 Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For ... Potential for the pouch to contain an extra laminate layer, creating the potential for the device... Class II Covidien Llc
Feb 23, 2021 Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended ... Evidence of face masks or other material in the seal in several kits, causing improper seals and ... Class II Trinity Sterile, Inc.
Feb 22, 2021 Smart Port CT-Implantable Port Catalogue #: CT96STSD-VI, CT96STSA-VI - Produc... AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Feb 22, 2021 AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer... AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits... Class II Angiodynamics Inc. (Navilyst Medical Inc.)
Feb 12, 2021 PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter i... Teleflex is recalling this product due to a lack of assurance of sterility. Class II TELEFLEX MEDICAL INC
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cmJL 3.5 Model Number: LA6JL35 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cm JR 4.0 Model Number: LA6JR40 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100cm EBU 3.75 Model Number: LA6EBU375 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 15, 2021 Medtronic 6F Launcher Guide Catheter 100 cm EBU 3.0 Model Number: LA6EBU30 Sterility may be compromised due to an unsealed pouch Class II Medtronic Vascular
Jan 4, 2021 Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hol... Product distributed with a red tape as part of the sterile packaging which could impact the seal ... Class II Ethicon, Inc.
Dec 23, 2020 BD Hypodermic Syringe 10 ml, eccentric tip. Catalog (Ref No.) 305482 The product packaging for the 10 ml eccentric tip syringe may exhibit open seals. An open seal i... Class II Becton Dickinson & Company
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 93092, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 91101, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Dec 8, 2020 Medtronic Ares Antibiotic-Impregnated Catheter, REF: 95001, Sterile, Rx Only.... There is a potential for a defect on the seal of the outer pouch of catheters. The defect may com... Class II Medtronic Neurosurgery
Nov 25, 2020 RapidFire Clip, Item Number 95-0154 - Product Usage: Fixation of Craniofaci... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 RingLoc+ Quick Connect Drill Bit, Item numbers 31-323215, 31-323220, 31-323... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Titanium IFS, Item number 909680 - Product Usage: Bone to bone fixation. Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 6.5/8.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0,... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 1035... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0,... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 1... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 RINGLOC BIPOLAR Hip System Bi Polar Locking Ring, Item number 11-165304 - Pro... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 M/H MODULAR STEM, Item number 13-104756 - Product Usage: intended for use in ... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 PHOENIX, Interlocking screw for IM nail, Item numbers 14-405040, 14-405042, 1... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Sterile Trac System Thinflap 24 MM Burr Hole Plate, Item number SP-STA-1021-1... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Custom Cancellous Thread, Item numbers CP161941, CP161943 - Product Usage: ... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Oxford Fixed Lateral, Item numbers 154330, 154370, 154373 154376 - Product U... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 Comprehensive Total Shoulder System/Bio-Modular Choice Shoulder System, Item ... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 25, 2020 3.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5... Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach... Class II Biomet, Inc.
Nov 20, 2020 HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/... The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product... Class II Maquet Cardiovascular Us Sales, Llc
Nov 20, 2020 HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product ... The HLS Set Advanced (disposable for Cardiohelp) is being recalled due to breaches in the product... Class II Maquet Cardiovascular Us Sales, Llc
Aug 26, 2020 EVOLVE STEM 8.5MM Model # 496S085 Lack of sterility assurance Class II Wright Medical Technology Inc
Aug 21, 2020 4 In. Flat Responder Emergency Trauma Dressing part number 30-0171, packaged ... Lack of sterility assurance of the 30-0171 Class II North American Rescue LLC.
Aug 12, 2020 Central Line Dressing Change Tray Potential of incomplete seals impacting the sterility of the kit. Class II Medline Industries Inc
Aug 7, 2020 Pleur-evac Thoracic Catheters Catalog No: DTRC-20S The thoracic catheter ... Potential sterility issue Class II TELEFLEX MEDICAL INC
Jul 6, 2020 Arrow TheraCath Epidural Catheter - Product Usage: The Arrow Epidural Cathete... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International Inc
Jul 6, 2020 Arrow Single Shot Epidural Anesthesia Kit - Product Usage: The Arrow Blunt Ne... The lidstock states the incorrect expiration date for the product. This issue could result in use... Class II Arrow International 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.