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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

4,602 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
Jul 1, 2016 OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: ... Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial leng... Class II Nidek Inc
Jul 1, 2016 Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 serie... There is an observed failure of the backrest bracket which can fatigue over the life time of the ... Class II Sunrise Medical (US) LLC
Jun 27, 2016 The Synchron Systems No Foam DxC (Reference No. B64130) affects the UniCel Dx... Beckman Coulter has identified an incompatibility between No Foam DxC reagent (REF B64130) and th... Class II Beckman Coulter Inc.
Jun 24, 2016 BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tub... One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to a... Class II Becton, Dickinson and Company, BD Biosciences
Jun 24, 2016 Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a sing... The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year... Class II Danville Materials, Inc.
Jun 23, 2016 EtCO2 Module -Part Number: 02.01.210699 Monitors: iM80, iM50, M50, iM70, iM60... Incorrect CO2 readings with some patient monitors. Class II Edan Diagnostics
Jun 23, 2016 Optical Surface Monitoring System{Align RT Plus} This is used on Varian's Tru... Varian Medical Systems has received reports that unintended changes were made to planned couch p... Class II Varian Medical Systems, Inc.
Jun 23, 2016 Optical Surface Monitoring System{OSMS, Varian Private Label} This is used on... Varian Medical Systems has received reports that unintended changes were made to planned couch pa... Class II Varian Medical Systems, Inc.
Jun 22, 2016 Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple tes... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple ... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test th... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 Replace Select T... Incorrect top label on an implant package. Class II Nobel Biocare Usa Llc
Jun 22, 2016 Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple te... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that u... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple ... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 22, 2016 Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92... The Positive Control information referencing human plasma as the antibody material described in t... Class III Alere San Diego, Inc.
Jun 20, 2016 Image1 SPIES X-LINK Camera Control Unit (CCU), Product Model No. TC301, when ... Potential electrical interference issue when the Image1 SPIES X-LINK and Image1 SPIES D1 camera h... Class II Karl Storz Endoscopy
Jun 10, 2016 Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vi... An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in thi... Class II Dako North America Inc.
Jun 8, 2016 Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramag... Demonstrate an upward shift in patient results. Class II Beckman Coulter Inc.
Jun 7, 2016 Instructions for Use (IFU) for Progesterone 3 Calibrator Set, repackaged as o... Instructions For Use had incorrect lot number and calibrator values Class III Tosoh Bioscience, Inc.
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 1 MM X 2 CM MODEL Number: M0035421... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Covidien Cytosponge Cell Collection Device. Item code CYTO-101-01. Gastro... Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two repor... Class II Covidien, LLC
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 4 CM MODEL Number:M00... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 3MM X 6CM MODEL Number:M0035443060... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 3MM X 8CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 2MM X 3CM MODEL Number:M0035442030... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2MM X 3CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 1.5 MM X 2 CM MODEL Number: M00354... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2MM X 6CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 3MM X 4CM MODEL Number:M0035443040... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 1 CM MODEL Number:M00... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 1 MM X 3 CM MODEL Number: M0035421... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2MM X 2CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1 MM X 2 CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 3CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1 MM X 3 CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 3 CM MODEL Number:M00... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 3MM X 6CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2MM X 4CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1 MM X 1 CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 3MM X 4CM MODEL Number:M003545... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 3.5 MM X 6CM MODEL Number:M0035443... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Covidien Cytosponge Cell Collection Kit. Contains Cytosponge Cell Collection... Medtronic is recalling all lots of the Covidien Cytosponge Cell Collection device after two repor... Class II Covidien, LLC
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 2MM X 4CM MODEL Number:M0035442040... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 1.5 MM X 3 CM MODEL Number: M00354... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 1.5 MM X 4 CM MODEL Number:M003542... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET 360 NANO 2.5 MM X 4CM MODEL Number:M0035442... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 2.5MM X 4CM MODEL Number:M0035... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular
Jun 6, 2016 Target Detachable Coils: TARGET HELICAL NANO 1.5 MM X 2 CM MODEL Number:M00... Stryker Neurovascular has become aware that some units of Target Nano product do not have the int... Class II Stryker Neurovascular

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.