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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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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

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Browse Device Recalls

2,447 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,447 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 2,447 FDA device recalls.

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DateProductReasonClassFirm
Oct 20, 2015 iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013; iCup DX 10 Pane... Ameditech is recalling drug abuse tests because they have shown reduced reactivity. Class II Ameditech Inc
Oct 14, 2015 Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M,... The following MRx software issue has been identified: MRx model M3535A with software version F.03... Class II Philips Electronics North America Corporation
Oct 14, 2015 HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per bo... DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorr... Class II DeRoyal Industries Inc
Oct 7, 2015 Helioseal F Sealant Refill 1 x 1.25 g, REF 558519AN, and Helioseal F Assortme... A defect occurred in the production process of Helioseal F Sealant; the particles in the faulty c... Class II Ivoclar A. G.
Sep 28, 2015 Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm- Sterile... The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.41... Class II Synthes (USA) Products LLC
Sep 22, 2015 Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devi... Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Inject... Class II Integra LifeSciences Corp. d.b.a. Integra Pain ...
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 15, 2015 AltiVate Humeral Socket Shell Trial, Part Number 804-06-052 The glenoid ba... Difficulty assembling the shell trial to the broach and the retaining ring disassembled from the ... Class II Encore Medical, Lp
Sep 14, 2015 Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates an... Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120... Class II Synthes (USA) Products LLC
Sep 11, 2015 NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne d... When using the NicoletOne v5.94 software, after exiting the impedance check function and returnin... Class II Natus Neurology Inc
Sep 11, 2015 Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder ... Incorrect expiration date on label. Correct expiration date was March 25, 2019. Product was labe... Class III Acumedia Manufacturers, Inc.
Aug 14, 2015 SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR ... The dimensions of the mating features of the recalled products are out of specification causing t... Class II Limacorporate S.p.A
Aug 14, 2015 SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoul... The dimensions of the mating features of the recalled products are out of specification causing t... Class II Limacorporate S.p.A
Aug 12, 2015 FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter:... The expiration date was incorrectly printed on the pouch/box labels of 19 products that were ship... Class III Abbott Electrophysiology
Aug 6, 2015 Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 5950... SynCardia Systems, Inc. is recalling Freedom Drivers due to a specific component of the drive mec... Class I SynCardia Systems Inc.
Jul 31, 2015 Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. ... Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restr... Class II Edward Lifesciences, Llc
Jul 20, 2015 Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Hea... Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported t... Class II Trilliant Surgical Ltd.
Jul 16, 2015 Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality... Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Vo... Class I Covidien LP (formerly Nellcor Puritan Bennett I...
Jul 15, 2015 EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-... Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate. Class I Medtronic Cardiovascular Surgery-the Heart Valv...
Jul 13, 2015 RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Inte... Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can g... Class II Sedecal S.A.
Jul 7, 2015 RadiForce RX850, 8MP Color LCD Monitor, Part Code No. 0FTD1958A2, UPC 6905920... EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particu... Class II Eizo Corporation
Jul 7, 2015 RadiForce RX650, 6MP Color LCD Monitor, Part Code No. 0FTD1957A5, 0FTD195B5, ... EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particu... Class II Eizo Corporation
Jul 7, 2015 RadiForce GX540, 5MP Monochrome LCD Monitor, Part Code No. 0FTD1826A5, 0FTD18... EIZO is recalling the RadiForce LCD Monitors could display abnormally while connecting to particu... Class II Eizo Corporation
Jun 30, 2015 PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Pr... Ventricular packing: LV software programming versions for BIOTRONIK CRT-P and CRT-D devices are ... Class II BIOTRONIK, Inc.
Jun 12, 2015 ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Arti... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: T... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surf... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation S... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Artic... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articul... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
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
Jun 12, 2015 ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Art... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Arti... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Artic... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 12, 2015 ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Arti... Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Kne... Class II DePuy Orthopaedics, Inc.
Jun 9, 2015 Olympus Scientific Solutions Americas Analytical X-ray System. Delta, Delta... Higher than published scatter around the probe head when testing some samples. At the point the c... Class II Olympus Scientific Solutions Americas
Jun 3, 2015 Oxford Femoral Drill Guide Lateral IM Adapter Product Usage: Drill gui... Oxford Femoral Drill Guide Lateral IM Adapter may have an undersized diameter that can cause an i... Class II Biomet, Inc.
May 29, 2015 ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance... Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our EL... Class II Mortara Instrument, Inc
May 29, 2015 Triathlon PS X3 Tibial Insert; No. 3 Triathlon TS Plus Tibial Insert X3 Poly ... Stryker Orthopaedics received a report that 5537-G-319 No 3. Triathlon TS Plus Tibial Insert X3 P... Class II Stryker Howmedica Osteonics Corp.
May 13, 2015 3.2 mm Cannulated Drill Bit/ QC 170 mm 2.7 Cannulated Drill Bit/ QC 160 mm ... affected parts and lots of the Cannulated Drill Bits have the potential to break during use Class II Synthes, Inc.
May 13, 2015 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the C... Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were foun... Class II Synthes, Inc.
May 8, 2015 Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGua... Reports where patients who recently switched from the current Shiley Neonatal and Pediatric produ... Class I Covidien LP (formerly Nellcor Puritan Bennett I...
May 8, 2015 Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. M... Reports where patients who recently switched from the current Shiley Neonatal and Pediatric produ... Class I Covidien LP (formerly Nellcor Puritan Bennett I...
May 4, 2015 Navigation System II-Cart, 7700-100-000 with Articulated Arm Camera, 7700-103... Stryker initiated a device recall of the Navigation System II-Cart, Camera Articulated Arm becaus... Class II Stryker Instruments Div. of Stryker Corporation
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 29, 2015 HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Produ... Failures of the splice repair kit if exposed to excessive force. Class I HeartWare Inc
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac tr... Complaints with the HVAD Abnormal Power Source Switching. Class II HeartWare Inc
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 ... Complaints with the HVAD Internal Controller Alarm Battery failures. Class I HeartWare Inc
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD). Catalog #'s US: 1101 and 1103 / ... HeartWare has received complaints relating to damage or bent connection pins within the power sup... Class I HeartWare 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.