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

4,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,602 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 4,602 FDA device recalls in CA.

Clear
DateProductReasonClassFirm
May 21, 2014 Single Site US Manuals and Single Site OUS Manuals for the da Vinci Standard ... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Vessel Sealer QRG for the da Vinci Standard Surgical System; da Vinci S Sys... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Cautery QRG for the da Vinci Standard Surgical System; da Vinci S System an... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Vision Troubleshooting Guide for the da Vinci Standard Surgical System; da ... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Insert for IRK for the da Vinci Standard Surgical System; da Vinci S System... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S Syst... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 Integra UCR 3mm Hex, Large Axial Driver. The UCR Hex Axial Driver is a sur... Integra has identified through an investigation of complaints that there may be the potential for... Class II SeaSpine Inc
May 21, 2014 Connection QRG for the da Vinci Standard Surgical System; da Vinci S System... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 System Manual for the da Vinci Standard Surgical System; da Vinci S System an... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 21, 2014 IRK QRG for the da Vinci Standard Surgical System; da Vinci S System and da... Multiple updates to User Manuals, Instructions for Use (IFU), Quick Reference Guides (QRG), and I... Class II Intuitive Surgical, Inc.
May 19, 2014 Shaver Handpiece Sterilization Tray. Model number 272-700-000. For steriliza... STERRAD 100S parameters provided in the Shaver Handpiece reprocessing guide (P10299 Revision A) d... Class II Stryker Endoscopy
May 16, 2014 GYC-1000 Green Laser Photocoagulator system The Nidek Green Laser Photocoa... Laser Aperture label was not applied to certain GYC-1000 Green Laser Photocoagulators devices in ... Class II Nidek Inc
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Large Cur... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Asymmetr... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 Simplexa" Flu A/B & RSV Direct, Model Number: MOL2650. 510(k) K120413 ... Focus Diagnostics is providing an urgent safety notice for a correction to the labeling for Simpl... Class II Focus Diagnostics Inc
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm) Standard ... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Asymmetri... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 10m x 8F (2.67mm) Standard ... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 15, 2014 IntellaTip MiFi XP Temperature Ablation Catheter; 8mm x 8F (2.67mm); Large Cu... Some units of Intella Tip MiFi XP Temperature Ablation Catheters were not manufactured according ... Class II Boston Scientific Corporation
May 14, 2014 Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Sys... Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were pote... Class II Beckman Coulter Inc.
May 14, 2014 MicroScan -Neg Breakpoint Combo Panel Type 34; Catalog number B1017-404; Pan... Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion... Class II Beckman Coulter, Inc.
May 12, 2014 Toshiba Infinix X-Ray Interventional System INFX-8000V/UU. An X-Ray system ... Although the Flat Panel Detector (FPD) touch sensor is activated during use, the error message is... Class II Toshiba American Medical Systems Inc
May 9, 2014 Patient Side Cart assembly, 4-arm, for use with Intuitive Surgical, Inc. da V... Torque wrenches used to tighten certain PSC bolts were out of calibration. This could lead to ove... Class II Intuitive Surgical, Inc.
May 5, 2014 Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50... When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error ca... Class II Philips Healthcare Informatics, Inc.
May 2, 2014 Alere Triage¿ D-Dimer Test PN 98100, Lot W53884B. The Alere Triage¿ D-Dimer... Alere initiated this recall because a limited number of Alere Triage¿ D-Dimer devices from PN 981... Class II Alere San Diego, Inc.
Apr 30, 2014 Varian On-Board Imager Advanced Imaging System. The On-Board Imager device... Varian MedicalSystems' X-ray generator Supplier (CPI) has identified that 32 VMS150 X-ray Generat... Class II Varian Medical Systems, Inc.
Apr 23, 2014 Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits... CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software ... Class I CareFusion 303, Inc.
Apr 23, 2014 ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35) and using S... Potential malfunction due to a software issue for ACUSON SC2000 ultrasound systems using software... Class II Siemens Medical Solutions USA, Inc.
Apr 23, 2014 ACUSON SC2000 Ultrasound Systems with software version 3.5 (VA35); ultrasoun... Software issues with ACUSON SC2000 ultrasound with software version 3/5 (VA35) - may incorrectly... Class II Siemens Medical Solutions USA, Inc.
Apr 23, 2014 Enaly 1000 BT-12 Ozone Generator, Model # 1000BT-12 The 1000BT-12 ozone ge... William Domb is recalling the Enaly 1000 BT-12 Ozone Generator because it is not approved or clea... Class II William C. Domb, D.M.D., A Professional Corpora...
Apr 22, 2014 UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrate... Possible leaking of No Foam solution from the No Foam Bottle Assembly on the UniCel DxC Synchron ... Class II Beckman Coulter Inc.
Apr 17, 2014 APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233... Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collectio... Class III Gen-Probe Inc
Apr 16, 2014 Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Al... Test Strips may report an inaccurately low INR result. Several patients had a therapeutic or nea... Class I Alere San Diego, Inc.
Apr 16, 2014 Tissue-Tek PARAFORM PROC/EMB/MEDIUM, FORMULA 3 - 8x1Kg. for diagnostic chemi... This Lot has variations in melting temperature. Class II Sakura Finetek USA Inc
Apr 16, 2014 12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray i... Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide d... Class II Stryker Endoscopy
Apr 14, 2014 TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), ... The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that... Class II Tenex Health Inc
Apr 8, 2014 Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) ... There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Cal... Class II Bio-Rad Laboratories, Inc.
Apr 8, 2014 MicroScan Pos Combo Panel Type 33 (PC33): Catalog number B1017-211 Micro... Siemens investigation confirmed that a portion one lot of panel Pos Combo 33 lot was packaged wi... Class II Beckman Coulter, Inc.
Apr 7, 2014 PolypVac 3.5mm Microdebrider; Catalog Number FG-000016; contents: 1 Microdebr... The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a compo... Class III Laurimed LLC
Apr 4, 2014 Anti EpCam PE - Analyte Specific Reagent. Anti-EpCAM is directed against h... Two lots of Anti EpCAM PE-Analyte Specific Reagent are mislabeled - the actual antibody present i... Class II BD Biosciences, Systems & Reagents
Apr 3, 2014 iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ul... Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullb... Class II Boston Scientific Corporation
Apr 3, 2014 Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This dev... Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a ... Class II Shimadzu Medical Systems
Apr 2, 2014 Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, ... When fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are use... Class II Siemens Medical Solutions USA, Inc.
Apr 1, 2014 Pipeline Embolization Device (PED). Used endovascular treatment of adults wi... Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delive... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Apr 1, 2014 7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen de... After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manu... Class II ZOLL Circulation, Inc.
Apr 1, 2014 Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculatur... Potential for the PTFE (polytetrafluoroethylene) coating to delaminate and detach from the delive... Class I Micro Therapeutics Inc, Dba Ev3 Neurovascular
Mar 27, 2014 Sit/stand Rolling Walker, SKU/Item Number 66838. Intended for use by those w... Harbor Freight Tools intiaited a recall of Sit/Stand Rolling Walker (SKU/Item Number 66838, sold ... Class II Central Purchasing LLC DBA Harbor Freight Tools
Mar 26, 2014 ToxCup Drug Screen Cup, Catalogue Numbers: HT15, HT15A, PT11, PT11A, PT15A, P... May be labeled with incorrect result interpretation graphics on the ToxCup lid label. Class II Branan Medical Corporation
Mar 25, 2014 Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 4... Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, L... Class II Ormco/Sybronendo
Mar 25, 2014 Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number ... Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 0... Class II Ormco/Sybronendo

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.