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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

4,686 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,686 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 4,686 FDA device recalls in CA.

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DateProductReasonClassFirm
Feb 11, 2015 EndoWrist One Vessel Sealer, 8MM, IS4000, 6 pack used in conjunction with th... Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to... Class II Intuitive Surgical, Inc.
Feb 11, 2015 Medical Device Exchange PhysioMesh Flexible Composite Mesh 15 x 15cm; Pouch... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 12x40 Airway Stent System; Pouch, Tyvek/Mylar, Ster... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Trocar VersaPort Plus V2; 5mm -11mm; Pouch, Tyvek... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single ... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - 5.5mm BioComposite Corkscrew FT, Vented Suture An... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange FIBERWIRE SUTURE SCISSOR; Pouch, Tyvek/Mylar, Steri... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Steri... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Round Fluted Bur Aggressive; 4.0mm; Pouch, Tyvek/My... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Dilating Tip Trocar w/Stability Sleeve 12mm; Pouc... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; ... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Outer cardboard box labeling: Pinnacle Cure Sleeve, Curing Light Tip Sleeves... Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes label... Class II Sybron Dental Specialties
Feb 11, 2015 Medical Device Exchange Round Fluted Bur Soft Touch; 2.0mm; Pouch, Tyvek/My... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Auto Suture Endo Universal 65¿¿ 4mm; Pouch, Tyvek... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Ty... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single ... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange TAUT Intraducer Peritoneal Catheter 2mm x 1.6mm x 7.... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 10x40 Airway Stent System; Pouch, Tyvek/Mylar, Ster... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 3.5mm Threaded Cerclage Pin; Pouch, Tyvek/Mylar, St... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Mayfield Disposable Skull Pin; Pouch, Tyvek/Mylar... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Sin... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, S... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 EndoWrist One Vessel Sealer, IS3000, 6 pack used in conjunction with the da V... Intuitive Surgical has identified the potential for a certain, small portion of Vessel Sealers to... Class II Intuitive Surgical, Inc.
Feb 11, 2015 Medical Device Exchange Round Diamond Bur Extra Coarse; 3.0mm; Pouch, Tyvek... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; P... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
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
Feb 11, 2015 Medical Device Exchange -Suction Coagulator; Pouch, Tyvek/Mylar, Sterile, S... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange 2.15MMX22MM Fluted Spiral Router for CRANI-A; Pouch... EXP did not register as a medical device establishment, list the devices being recalled, or estab... Class II EXP Pharmaceutical Services Corp
Feb 11, 2015 Medical Device Exchange PT WIRE 300; Pouch, Tyvek/Mylar, Sterile, Single Us... EXP did not register as a medical device establishment, list the devices being recalled, or esta... Class II EXP Pharmaceutical Services Corp
Feb 10, 2015 G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glyc... The G7 Variant Elution Buffer HiS no. 1 (M) is incorrectly labeled with an expiration date of Oct... Class III Tosoh Bioscience, Inc.
Feb 5, 2015 Zip 16 Surgical Skin Closure Device; 16 cm Product number PS1160; Rx only, ... The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for s... Class II Zipline Medical
Feb 5, 2015 Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product numbe... The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for s... Class II Zipline Medical
Feb 5, 2015 Zip 8i Surgical Skin Closure Device; for incisions up to 8 cm. Product numb... The manufacturers seal may not be present on the Nylon pouch resulting in lack of assurance for s... Class II Zipline Medical
Feb 3, 2015 IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material n... Reports of formation of char adherent to the proximal part of the distal tip electrodes Class I Boston Scientific Corp
Jan 23, 2015 MAX-TL 9.0 x 7.0 mm Implant, Catalog No. 15711K; Z-MAX Implant 9.0 x 7 mm Len... Z-MAX Implant, 9mm diameter, 7mm length labeled package, catalog number Z-MAX9-7, contained a MAX... Class II Southern Implants, Inc
Jan 22, 2015 GemLock Long Hex Driver, Catalog RHL2.5; Also distributed within the Tapered ... The Gemlock Long Hex Driver may not fit into the Fixture Mount Transfer (FMT) or the internal hex... Class II Zimmer Dental Inc
Jan 21, 2015 HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with th... Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user o... Class II Intuitive Surgical, Inc.
Jan 21, 2015 Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Pict... Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Modu... Class II TeraRecon, Inc.
Jan 21, 2015 HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use ... Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user o... Class II Intuitive Surgical, Inc.
Jan 15, 2015 da Vinci Si Surgical System, IS3000; - Wall chart for EndoWrist Stapler 45 Sy... The Wall chart has been updated because it was noted that Wall Chart (PN 551524-03 Rev A) was inc... Class II Intuitive Surgical, Inc.
Jan 13, 2015 SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusio... CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage i... Class II CareFusion 303, Inc.
Jan 12, 2015 ACUSON S2000 Automated Breast Volume Scanner (ABVS), model number 10434730. ... There is a low probability the scanner arm will become completely detached from the scanner column. Class II Siemens Medical Solutions USA, Inc.
Jan 12, 2015 ACUSON SC2000 Ultrasound System, Model 10433816, component 10040596 - UILK2. ... The bolt holding the control panel of the ACUSON SC2000 in a fixed position may fail and the Cont... Class II Siemens Medical Solutions USA, Inc.
Jan 9, 2015 Alive ECG App 2.1.2 ( a medical device application for the Apple iOS operatin... Alive ECG App version 2.1.2 (intended to be used with the AliveCor Heart Monitor) crashed upon us... Class III Alivecor SFO
Dec 24, 2014 Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425 Advanced Sterilization Products (ASP) is recalling the Tyvek Rolls with STERRAD Chemical Indicato... Class II Advanced Sterilization Products
Dec 22, 2014 SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA ... The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new f... Class II Vitrolife Inc
Dec 19, 2014 Anti-Lambda APC-H7, Catalog Number 656157. Product Usage: Intended for ... Two lots of the Anti-Lambda APC-H7 antibody are contaminated with CD38 antibody. Class II BD Biosciences, Systems & Reagents
Dec 19, 2014 CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: ... One lot of CD8 PE is contaminated with CD4 FITC and may cause an unexpected staining pattern and ... Class II BD Biosciences, Systems & Reagents
Dec 19, 2014 Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1. There is the potential for the height adjustable handle to dislodge due to failing locking mechan... Class II Sunrise Medical (US) LLC

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.