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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

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

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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.

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DateProductReasonClassFirm
Nov 26, 2013 Access 2 Immunoassay System Analyzer. The Access Immunoassay System is ... The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured... Class II Beckman Coulter Inc.
Nov 26, 2013 UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay... The Access 2 Immunoassay System Analyzer and the UniCel DxI 600 Access may have been manufactured... Class II Beckman Coulter Inc.
Nov 26, 2013 STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be... Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI... Class II Advanced Sterilization Products
Nov 25, 2013 Viscocel and Viscocel Plus. These products are intraocular fluid devices c... CLR Medicals International Inc., initiated a nationwide recall of Viscocel and Viscocel Plus, in ... Class I C.L.R. Medicals International, Inc.
Nov 25, 2013 HT Connect Peripheral Guide Wire Part Number Description 1012587 ... Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small nu... Class II Abbott Vascular, Inc.
Nov 22, 2013 D-10 Dual Program, which contains Update Kit D-10 A1c program diskette. Un... D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not b... Class III Bio-Rad Laboratories, Inc.
Nov 21, 2013 ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for ... Horiba Medical is recalling the ABX PENTRA N Control because it has been updated to include a rev... Class II Horiba Instruments, Inc dba Horiba Medical
Nov 19, 2013 Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-pa... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, Inc.
Nov 19, 2013 Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,sing... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, Inc.
Nov 19, 2013 Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, Inc.
Nov 19, 2013 Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-pack... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, Inc.
Nov 19, 2013 Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-pac... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, Inc.
Nov 19, 2013 Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-pac... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, Inc.
Nov 19, 2013 Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-p... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, Inc.
Nov 19, 2013 Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs... Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin ... Class II Asante Solutions, Inc.
Nov 18, 2013 CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; CSF-... Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St... Class II Medtronic Neurosurgery
Nov 18, 2013 Medtronic Strata II Shunt Assembly Kit, Small, Catalog No. 27848. Strata ... Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St... Class II Medtronic Neurosurgery
Nov 18, 2013 FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. ... Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low bl... Class I Abbott Diabetes Care, Inc.
Nov 18, 2013 Medtronic Delta Shunt Assembly Kit with Bioglide Small, Performance Level 1.0... Medtronic Neurosurgery is recalling the CSF-Unitized Shunts, Delta Shunt Assembly Kit, and the St... Class II Medtronic Neurosurgery
Nov 18, 2013 Plan Parameters workspace within Eclipse Treatment Planning System Version 1... An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a ... Class II Varian Medical Systems, Inc.
Nov 18, 2013 FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 co... Certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips produce erroneously low bl... Class I Abbott Diabetes Care, Inc.
Nov 15, 2013 Mobile X-ray System, Model: MUX-100, MUX-100H Product Usage: The device i... Shimadzu Corporation is recalling the Shimadzu Mobile X-ray Sytems (MUX-100 and MUX-100H) because... Class II Shimadzu Medical Systems
Nov 15, 2013 Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, ... Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers ... Class II Intuitive Surgical, Inc.
Nov 15, 2013 Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, ... Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers ... Class II Intuitive Surgical, Inc.
Nov 14, 2013 VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690... Accumetrics is recalling the VerifyNow IIb/IIIa 10-Test because it contains incorrect information... Class II Accumetrics Inc
Nov 13, 2013 Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: ... Product shipped to US customers had non U.S. Instruction for use with indication for Use that wer... Class II Concentric Medical Inc
Nov 12, 2013 Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety... Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond... Class II Ansell Sandel Medical Industries LLC
Nov 12, 2013 Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable S... Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond... Class II Ansell Sandel Medical Industries LLC
Nov 12, 2013 Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety... Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond... Class II Ansell Sandel Medical Industries LLC
Nov 12, 2013 Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety... Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond... Class II Ansell Sandel Medical Industries LLC
Nov 12, 2013 Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety... Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond... Class II Ansell Sandel Medical Industries LLC
Nov 12, 2013 Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety... Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond... Class II Ansell Sandel Medical Industries LLC
Nov 12, 2013 Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable S... Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond... Class II Ansell Sandel Medical Industries LLC
Nov 11, 2013 Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (... There is a remote possibility for the plastic latch to deform over the lifetime of use. When thi... Class II Sunrise Medical (US) LLC
Nov 11, 2013 Assembly, Patient Side Manipulator on da Vinci Surgical Systems: da Vinci S ... Reports of friction within certain instrument arms can interrupt smooth instrument motion. This c... Class II Intuitive Surgical, Inc.
Nov 11, 2013 STERRAD NX, Product Code: 10033 The STERRAD Steri lization System is a low... Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization... Class II Advanced Sterilization Products
Nov 11, 2013 STERRAD 100NX, Product Code: 10104 The STERRAD Steri lization System is a ... Advanced Sterilization Products (ASP) is recalling the STERRAD NX and STERRAD 100NX sterilization... Class II Advanced Sterilization Products
Nov 8, 2013 Coulter DxH Cleaner 10L, Part No. 628023. For use on UniCel DxH Systems fo... Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... Class II Beckman Coulter Inc.
Nov 8, 2013 FastPack Free T4 Immunoassay Chemilunescence assay for the determination of... Qualigen initiated this recall because the FastPack kit may cause lower than expected results due... Class II Qualigen Inc
Nov 8, 2013 FastPack Total PSA Immunoassay Chemilunescence assay for the determination ... Qualigen initiated this recall because the FastPack kit may cause lower than expected results due... Class II Qualigen Inc
Nov 8, 2013 SmartSite Low Sorbing Infusion Set with Texium Close Male Luer, Model No. 243... CareFusion is recalling the SmartSite Low Sorbing Infusion Set with Texium Closed Male Luer becau... Class II CareFusion 303, Inc.
Nov 8, 2013 Coulter LH 750 Hematology Analyzer, Part No. 6605632, A85570 Product Usag... Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degrada... Class II Beckman Coulter Inc.
Nov 8, 2013 VersaSafe Extension Set, Model No. 21000M-007 CareFusion is recalling the VersaSafe Extension Intravascular Administration Set because it may ... Class II CareFusion 303, Inc.
Nov 8, 2013 FastPack Testosterone Immunoassay Chemilunescence assay for the determinati... Qualigen initiated this recall because the FastPack kit may cause lower than expected results due... Class II Qualigen Inc
Nov 8, 2013 FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescen... Qualigen initiated this recall because the FastPack kit may cause lower than expected results due... Class II Qualigen Inc
Nov 8, 2013 Coulter DxH Cleaner 5L, Part No. 628022. For use on UniCel DxH Systems for... Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... Class II Beckman Coulter Inc.
Nov 8, 2013 Coulter LH 780 Hematology Analyzer, Part No. 723585, A90728 Product Usage... Beckman Coulter is recalling the LH 750 and LH 780 Hematology Systems because the optical degrada... Class II Beckman Coulter Inc.
Nov 8, 2013 UniCel DxH 600 Coulter Cellular Analysis System, Part No. B23858. Used for... Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... Class II Beckman Coulter Inc.
Nov 8, 2013 UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, a... Beckman Coulter is recalling the UniCel DxH800 and UniCel DxH600 Coulter Analysis Systems because... Class II Beckman Coulter Inc.
Nov 4, 2013 Stryker brand EXCELSIOR SL-10 PRE-SHAPED C 15OCM; Catalog Number: M0031441940... Products were shipped labeled with "use by" dates that exceed currently available shelf-life data... 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.