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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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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

4,606 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,606 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 4,606 FDA device recalls in CA.

Clear
DateProductReasonClassFirm
Jul 23, 2013 DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott L... Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an un... Class II Microgenics Corp
Jul 19, 2013 Pipeline Embolization Device (PED) The Pipeline Embolization Device is ind... Covidien Neurovascular has initiated the recall of several lots of Pipeline Embolization Device (... Class II Micro Therapeutics Inc, Dba Ev3 Neurovascular
Jul 18, 2013 PRIMUS, ONCOR, ARTISTE Linac systems with component Tabletop, 550TxT, TT-A s/... Siemens has become aware of a customer complaint concerning the rail threaded holes of the 550TxT... Class II Siemens Medical Solutions USA, Inc
Jul 17, 2013 Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually r... Beckman Coulter has received a customer complaint that suggests trending of positive results has... Class II Beckman Coulter Inc.
Jul 16, 2013 Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (... Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. ... Class III Zoll Circulation, Inc.
Jul 12, 2013 Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. ... Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws ... Class II Ormco/Sybronendo
Jul 12, 2013 OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution cont... The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the ... Class III Celera Corporation
Jul 10, 2013 Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-ster... PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Mar... Class II Precision Dynamics Corporation
Jul 10, 2013 Acuson SC2000 volume imaging ultrasound systems at software version 3.0. M... Software issue results in inaccurate 3D image may result in ablation in wrong location. Class II Siemens Medical Solutions USA, Inc.
Jul 3, 2013 Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332... Medtronic is recalling certain lots of Medtronic MiniMed Paradigm Reservoirs MMT-326A (1.8mL) and... Class II Medtronic MiniMed
Jun 28, 2013 Medtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated f... Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer cart... Class II Medtronic Neurosurgery
Jun 28, 2013 Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico MIS Posterior F... The firm initiated this recall of certain lots of Illico Ti Cannulated Polyaxial Screws 7.5mm x 4... Class II Alphatec Spine, Inc.
Jun 24, 2013 Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Cat... The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner... Class II Stryker Neurovascular
Jun 21, 2013 Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surg... The outer box label of the product was labeled with a down revision label which did not include t... Class II Myoscience Inc
Jun 19, 2013 20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilita... Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly ... Class II Biosense Webster, Inc.
Jun 17, 2013 Alaris PC unit, model 8015, with version 9.12-Keyboard Processor and logic bo... CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is ope... Class I CareFusion 303, Inc.
Jun 10, 2013 Afinity CQ2015A Intraocular Lens The visual correction of aphakia in perso... STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intr... Class II Staar Surgical Co.
Jun 10, 2013 nanoFLEX CC4204A Intraocular Lens Correct aphakia in persons 60 years of a... STAAR Surgical Company is recalling a limited number of nanoFLEX CC4204A and Afinity CQ2015A intr... Class II Staar Surgical Co.
Jun 8, 2013 da Vinci Instrument Control Box, model number ICB3000; Manufactured by Int... Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one... Class II Intuitive Surgical, Inc.
Jun 8, 2013 da Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuit... Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one... Class II Intuitive Surgical, Inc.
Jun 8, 2013 da Vinci Dual Camera Controller, model number DC3000; Manufactured by Intu... Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one... Class II Intuitive Surgical, Inc.
Jun 8, 2013 da Vinci Si Vision System Cart, model number VS3000; Manufactured by Intui... Factory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one... Class II Intuitive Surgical, Inc.
Jun 7, 2013 Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion set... Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMe... Class I Medtronic MiniMed
Jun 6, 2013 AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal de... The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complet... Class II Sybron Dental Specialties
Jun 4, 2013 Respironics V60 Ventilator, Model #V60 Respironics Material P/N (Philips 1... Respironics California, Inc. has initiated a recall on the V60 ventilator because of an issue wit... Class I Respironics California Inc
Jun 3, 2013 Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert O... Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the spon... Class II Alere San Diego, Inc.
Jun 3, 2013 AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Soft... The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyz... Class II Beckman Coulter Inc.
May 29, 2013 Siemens MEVATRON series, PRIMART (limited release)PRIMUS and/or ONCOR or ARTI... The information regarding the FILM Mode calibration may have been considered difficult to interpr... Class II Siemens Medical Solutions USA, Inc
May 29, 2013 ARTISTE with syngo RT Therapist version 4.3 Product Usage: The intended ... The potential for a safety issue, for the image quality degradation, that is addressed by the Cus... Class II Siemens Medical Solutions USA, Inc
May 28, 2013 STAR S3 ActiveTrack Excimer System (STAR S3) Mfg by AMO Manufacturing USA... Under specific conditions, there is an unlikely potential to result in inadvertent laser firing o... Class II Abbott Medical Optics, Inc.
May 28, 2013 VenaFlow Elite 30B-B and 30BI-B Product Usage: The VenaFlow Elite System... DJO, LLC has recently identified a product safety issue with the battery assembly for the VenaFlo... Class II DJO, LLC
May 28, 2013 STAR S4 IR Excimer System (STAR S4 IR) Mfg by AMO Manufacturing USA, LLC ... Under specific conditions, there is an unlikely potential to result in inadvertent laser firing o... Class II Abbott Medical Optics, Inc.
May 28, 2013 STAR S4 with Variable Spot Scanning Excimer System (STAR S4) Mfg by AMO M... Under specific conditions, there is an unlikely potential to result in inadvertent laser firing o... Class II Abbott Medical Optics, Inc.
May 28, 2013 SYNCHRON System(s) Lactate (LACT) Reagent. Product Usage: Lactate (LACT) ... Beckman Coulter has confirmed customer reports of LACT Lot M210077 failing calibration with erro... Class II Beckman Coulter Inc.
May 24, 2013 MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalm... Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory fun... Class II Nidek Inc
May 23, 2013 Sovereign¿ Compact Phacoemulsification System, v 5.3, Part Number: CMP680300.... Abbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Ad... Class II Abbott Medical Optics, Inc.
May 23, 2013 ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring Syste... Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the... Class II Sotera Wireless, Inc.
May 23, 2013 ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The... Sotera Wireless, Inc. is recalling the ViSi Mobile Monitoring System due to the potential for the... Class II Sotera Wireless, Inc.
May 16, 2013 Soma v Automated Breast Ultrasound System (ABUS), Automated Breast Ultrasound... Devices labeled for an intended use not included in the existing 510(k) or PMA, in that, the user... Class II U-systems Inc
May 15, 2013 Comfort brand Ear-Loop Face Mask, Item #: 3100, Model Numbers: # 3100B, # 310... Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard ... Class II Maytex Corp
May 14, 2013 Optovue iVue with Normative Database (NDB) with Software Version 3.0 and 3.1.... Colors from the NDB comparison for Ganglion Cell Complex thickness in the singular OU report in i... Class III Optovue, Inc.
May 13, 2013 Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Pr... It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TB... Class II Microgenics Corporation
May 13, 2013 Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 107984... Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports... Class I Endologix Inc
May 9, 2013 Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. T... An inconsistency was identified related to electronic display identification of the optional Mult... Class II ConBio, a CynoSure Company
May 8, 2013 8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distri... Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors ver... Class II Intuitive Surgical, Inc.
May 8, 2013 8mm Fenestrated Bipolar Forceps used in conjunction with the da Vinci Surgic... Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipol... Class II Intuitive Surgical, Inc.
May 8, 2013 8mm Precise Bipolar Forceps used in conjunction with the da Vinci Surgical S... Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipol... Class II Intuitive Surgical, Inc.
May 8, 2013 8mm Maryland Bipolar Forceps used in conjunction with the da Vinci Surgical S... Reports of dislodging of the Cautery Plug Insert from the Cautery Plug Riser, preventing a bipol... Class II Intuitive Surgical, Inc.
May 6, 2013 da Vinci 5 mm Flared Instrument Cannulae for use with the da Vinci S and Si S... Intuitive Surgical is implementing a voluntary Field Action to implement a modified inspection pr... Class II Intuitive Surgical, Inc.
May 6, 2013 Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide... Alphatec Spine initiated this medical device recall for the following reason: due to tolerancing,... Class II Alphatec Spine, 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.