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

2,907 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,907 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 2,907 FDA device recalls in 2015.

Clear
DateProductReasonClassFirm
Feb 11, 2015 Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single ... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture An... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Steri... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Steri... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; Pouch, Tyvek/My... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm; Pouc... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; ... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves... Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes label... Class II Sybron Dental Specialties
Feb 11, 2015 Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/My... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm; Pouch, Tyvek... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Ty... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single ... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 10x40 Airway Stent System; Pouch, Tyvek/Mylar, Ster... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 3.5mm Threaded Cerclage Pin; Pouch, Tyvek/Mylar, St... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 SMARTSET GHV Gentamicin Bone Cement. A self-curing, radiopaque, polymethyl m... One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in sur... Class II DePuy Orthopaedics, Inc.
Feb 11, 2015 Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Sin... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, S... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da V... Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to... Class II Intuitive Surgical, Inc.
Feb 11, 2015 Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Milestone Wand STA Handpiece for the delivery of local anesthesia to dental t... Wand Handpiece was mislabeled as STA handpiece. The Wand handpiece cannot be installed in the ST... Class III Milestone Scientific, Inc.
Feb 11, 2015 Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; P... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange ETS FLEX 45 ENDOSCOPIC ARTICULATING LINEAR CUTTER, ... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange -Suction Coagulator; Pouch, Tyvek/Mylar, Sterile, S... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Us... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 10, 2015 G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glyc... The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of Oct... Class III Tosoh Bioscience, Inc.
Feb 9, 2015 CooperSurgical PESSARY KIT-CUBE#2, 1-3/8 in , 35 mm Part Number: MXKPEC02 Incorrect size printed on the Milex Pessary Kit packaging label Class II CooperSurgical, Inc.
Feb 9, 2015 Philips Healthcare DuraDiagnost X- Ray The system is designed to emit a beep upon termination of an exposure. However, if the system ha... Class II Philips Medical Systems, Inc.
Feb 9, 2015 T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, ... Incorrect labeling of the expiration date Class II MRP, LLC dba AMUSA
Feb 9, 2015 Philips Healthcare DigitalDiagnost System X-Ray The system is designed to emit a beep upon termination of an exposure. However, if the system ha... Class II Philips Medical Systems, Inc.
Feb 6, 2015 Terumo HX2 Temperature Management System provides temperature control of two ... Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby... Class II Terumo Cardiovascular Systems Corporation
Feb 6, 2015 SIEMENS SOMATOM Force with software version VA50A and /or VA50A_FP1 and/or VA... Possibility of image artifacts during data acquisition when using Adaptive Cardio Sequence, Turbo... Class II Siemens Medical Solutions USA, Inc
Feb 5, 2015 Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lum... Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Tr... Class II Medical Components, Inc dba MedComp
Feb 5, 2015 Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, ... The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for s... Class II Zipline Medical
Feb 5, 2015 Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product numbe... The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for s... Class II Zipline Medical
Feb 5, 2015 Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem, Smooth Stem ... PMMA coating does not meet specifications. Area of the stem may be missing PMMA coating. Class II Zimmer, Inc.
Feb 5, 2015 ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Cod... Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rat... Class II Arrow International Inc
Feb 5, 2015 Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce ... 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2015 Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce c... 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2015 Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of 10- 100 ... Use of the product may not provide adequate recovery and could result in false negative identific... Class II Remel Inc
Feb 5, 2015 Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technol... Philips discovered that a software defect exists in marketed product wherein the sign indication ... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2015 Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cros... 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2015 Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product numb... The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for s... Class II Zipline Medical
Feb 5, 2015 Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produ... 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2015 Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. ... 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... Class II Philips Medical Systems (Cleveland) Inc
Feb 5, 2015 DermaPen Pro Model, Micro Needling System, a motorized AC powered surgical in... Derma Pen initiated a field communication for Dermapen after receiving an FDA warning letter for ... Class II Derma Pen, LLC

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.