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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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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
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
Nov 25, 2014 Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Ma... Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x ... Class II Zimmer, Inc.
Nov 24, 2014 Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number... Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... Class II Arthrosurface, Inc.
Nov 24, 2014 Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: ... Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... Class II Arthrosurface, Inc.
Nov 24, 2014 Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8... Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... Class II Arthrosurface, Inc.
Nov 24, 2014 Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Num... Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... Class II Arthrosurface, Inc.
Nov 24, 2014 Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number... Fully threaded Taper Post Fixation components not cleared for marketing in the US with current in... Class II Arthrosurface, Inc.
Nov 21, 2014 Bone Screw, self-tapping The Trilogy shells are available in three configura... Analysis of returned complaint devices, product in inventory, and device manufacturing records ha... Class II Zimmer Manufacturing B.V.
Nov 21, 2014 Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek ... Affected product may have compromised sterility due to packaging defects. It was determined that ... Class II Atricure Inc
Nov 19, 2014 Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, ... MRx Defib can be susceptible to one or both issues: 1. The C02 Inlet Port associated with end-tid... Class II Philips Medical Systems, Inc.
Nov 19, 2014 HeartStart MRx Monitor/Defibrillator; Model. Numbers: M3535A, M3536A, M3536J,... Device may malfunction, which could cause therapy to be delayed, disabled, or delivered inadverte... Class II Philips Medical Systems, Inc.
Nov 13, 2014 FLUTTER Percussor respiratory device, packaged one unit per clear plastic pac... Customer notification that the device may be difficult to open or close. Class II Aptalis Pharmatech Inc.
Nov 7, 2014 Ceramic Femoral Head. Intended for use in total hip arthroplasty applica... Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (... Class II DePuy Orthopaedics, Inc.
Nov 5, 2014 Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ... Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results ... Class II Toshiba American Medical Systems Inc
Nov 5, 2014 Q-Station Quantification Software. Q-Station 3.0 with a2DQ and/or aCMQ Q-Apps... When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... Class II Philips Ultrasound, Inc.
Nov 5, 2014 EPIQ 5 Ultrasound System, EPIQ 5 systems with software versions 1.0.x or 1.1.... When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... Class II Philips Ultrasound, Inc.
Nov 5, 2014 Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A ... Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results ... Class II Toshiba American Medical Systems Inc
Nov 5, 2014 EPIQ 7 Ultrasound System, EPIQ 7 systems with software versions 1.0.x or 1.1.... When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... Class II Philips Ultrasound, Inc.
Nov 5, 2014 Additional devices identified in new FSN MA-FCO 83000190: QLAB versions 10... When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) a... Class II Philips Ultrasound, Inc.
Nov 4, 2014 McGrath MAC2 Video Laryngoscope Blades Product supplied in box of 50 items... The blade retaining clip may be difficult to engage and thereby increase the possibility of a bl... Class II Aircraft Medical Limited
Oct 23, 2014 Nerve Block Tray (Nerve Block convenience kit) According to the recall notice received from Hospira, the recall was initiated due to a confirmed... Class II Centurion Medical Products Corporation
Oct 23, 2014 Pacemaker Tray (Cardiovascular Surgical Instruments convenience kit) According to the recall notice received from Hospira, the recall was initiated due to a confirmed... Class II Centurion Medical Products Corporation
Oct 23, 2014 Chest Tube Tray (Cardiovascular Surgical Instruments convenience kit) According to the recall notice received from Hospira, the recall was initiated due to a confirmed... Class II Centurion Medical Products Corporation
Oct 23, 2014 Diagnostic Imaging Tray (General Surgery convenience kit) According to the recall notice received from Hospira, the recall was initiated due to a confirmed... Class II Centurion Medical Products Corporation
Oct 17, 2014 INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0... An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxid... Class II INO Therapeutics (dba Ikaria)
Oct 10, 2014 The 5085 is a general surgical table with high patient weight capacity, exten... The 5085 and 5085SRT stainless steel column shrouds may become damaged as a result of misalignmen... Class II Steris Corporation

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.