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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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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
Dec 24, 2013 6" (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave" TConnector, R... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 8" (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 17 cm (7") Smallbore Trifuse Ext Set w/3 NanoClave¿ ( Light Blue, Lavender R... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 28" (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 13" Pentafuse Smallbore Ext Set w/NanoClave", 1.2 Micron Filter, 3 MicroClav... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 106" (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave" TConnector,... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 31 cm (12") Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syp... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 10" Smallbore Pentafuse Ext Set w/5 NanoClave", 5 Clamps, Rotating Luer, Par... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 NanoClave Stopcock, Part No. A1000, Item No. 011-AC100 The ICU Needleless Co... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 6" (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave", 2 Clamps, ... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 183 cm (72") Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings)... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 14" (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 103" (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave", Anti-Sipho... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 6" (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave¿, 3 Clamps,... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 78" Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave" T-Connec... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip, Item # B330... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 5" Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer, Item #... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 24, 2013 7" (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoCla... ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because ... Class II ICU Medical, Inc.
Dec 22, 2013 ACUSON SC2000 Ultrasound System; Power Input: 100-240VAC, 1600W Max, 50/60 H... The user interface assembly on the ACUSON SC2000 may become loose with the potential for the ent... Class II Siemens Medical Solutions USA, Inc.
Dec 22, 2013 ACUSON SC2000 Power Input: 100-240VAC, 1600 Max 50/60Hz; Siemens Medical ... The locking mechanism that is intended to hold the control panel in a fixed position can become l... Class II Siemens Medical Solutions USA, Inc.
Dec 20, 2013 Catalys Precision Laser System (United States) - Catalys-U: Catalys Precisio... Potential for unexpected heating of the transformer mounting bolt located within the system chass... Class II Optimedica Corporation
Dec 18, 2013 ABX PENTRA Urine Control L/H. The ABX PENTRA Urine Control L/H is a two-le... HORIBA Medical is informing all ABX PENTRA Urine Control L/H customers running the Creatinine ass... Class III Horiba Instruments, Inc dba Horiba Medical
Dec 16, 2013 STERRAD 50 Sterilization System, Product Code: 10050 The STERRAD 50 Steriliz... Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S S... Class II Advanced Sterilization Products
Dec 16, 2013 STERRAD NX Sterilization System, Product Code: 10033 The STERRAD NX Steril... Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S S... Class II Advanced Sterilization Products
Dec 16, 2013 STERRAD 100S Sterilization System, Product Code: 10101 The STERRAD 100S Ster... Advanced Sterilization Products (ASP) is recalling the STERRAD NX, STERRAD 50, and STERRAD 100S S... Class II Advanced Sterilization Products
Dec 13, 2013 SuperElastic Regular force NiTi lower or upper Natural arches. 0.16 size 10... Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark.... Class II Highland Metals, Inc.
Dec 13, 2013 SuperElastic Regular force NiTi lower or upper Natural arches. 0.14 size 10... Labeling issue: Product labeled as "Upper" may contain "Lower" archwires with a red midline mark.... Class II Highland Metals, Inc.
Dec 11, 2013 SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simvie... In a very rare occurrence an intended movement of the SimView NT simulation system components cou... Class II Siemens Medical Solutions USA, Inc
Dec 11, 2013 TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used ... Class II Toshiba American Medical Systems Inc
Dec 6, 2013 Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml... Reports that the product is not performing as expected. In house testing showed no staining on br... Class II Lab Vision Corporation
Dec 5, 2013 PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. ... Update to correct the possibility for patients or operators to have their fingers trapped or pinc... Class II Siemens Medical Solutions USA, Inc
Dec 5, 2013 Alaris PC unit model 8000 and 8015 with Alaris PCA module model 8120 and Auto... CareFusion is recalling the Alaris PC unit (model 8000 and 8015) because the Alaris PC unit will... Class I CareFusion 303, Inc.
Dec 2, 2013 MAS Omni Immune Controls The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; ho... Class III Microgenics Corporation
Dec 2, 2013 MAS Omni Immune PRO Controls The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; ho... Class III Microgenics Corporation
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

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.