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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

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

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DateProductReasonClassFirm
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
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 110... Complaints with the HVAD Retraction of Pins within the driveline connector. Class I HeartWare Inc
Apr 29, 2015 HeartWare Ventricular Assist System (HVAD) For use as a bridge-to-cardiac tra... Complaints with the HVAD Discolored and Cracked Driveline Outer Sheath. Class II HeartWare Inc
Apr 20, 2015 98" (249 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon ... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext S... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 108" (274 cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon ... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore T... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 113" (287cm) Transfer Set w/MicroClave T-Connector, Check Valve, Anti-Siphon ... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotati... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Apr 20, 2015 98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock... ICU Medical is recalling MicroClave T-Connectors because they have potential connection separatio... Class II ICU Medical, Inc.
Mar 27, 2015 The eCareManager system. Software intended for use in data collection, stora... A software defect may cause incorrect medication order change. If the user decides to edit the o... Class II Visicu, Inc.
Mar 19, 2015 Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable... A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-... Class II Incisive Surgical Inc
Mar 18, 2015 Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total ... Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once att... Class II Zimmer Gmbh
Mar 17, 2015 Medtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product... Possible performance issue when used with specific AA-sized (LR6) batteries. The negative termina... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Mar 11, 2015 ABG-HM-1 Hummi Micro Draw Blood Transfer Device; Used for blood transfer and ... Hummingbird Med Devices, Inc. is recalling the Hummi Micro Draw because of insertion difficulties. Class I Hummingbird Med
Mar 9, 2015 Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is use... Instrument Kits for OsteoSponge SC grafts, OsteoLock Facet Stabilization Dowel, and BacFast HD Fa... Class II Bacterin International, Inc.
Feb 25, 2015 LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03... Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficul... Class II Biosense Webster, Inc.
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
Jan 16, 2015 HeartWare Ventricular Assist System (HeartWare Controller) Product Usage: ... The affected clinical trial Controllers exhibit a higher susceptibility to ESD than newer commerc... Class I HeartWare Inc
Jan 12, 2015 Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxx... Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occas... Class II Covidien LP (formerly Nellcor Puritan Bennett I...
Dec 23, 2014 HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, ... MRx monitor/defibrillator could reboot at an indeterminate time, potentially causing therapy to b... Class II Philips Medical Systems, Inc.
Dec 15, 2014 Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E ... Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-... Class II Stryker Howmedica Osteonics Corp.
Dec 11, 2014 Persona (TASP) Tibial Articular Surface Provisional Shim, all sizes and Lots ... Potential for delay in surgery and/or ball bearings to be left in the wound. Repeated cycles of s... Class II Zimmer, Inc.
Dec 1, 2014 EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Kne... Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition wher... Class II Stelkast Co
Nov 26, 2014 VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as Co... Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon conta... Class III Lacrimedics 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.