Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 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 2,437 FDA device recalls in 2013.

Date	Product	Reason	Class	Firm
Dec 9, 2013	23ga Aspirating Endo Illuminator, Synergetics, length 7.5 ft, sterile / EO, 5...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	25ga Awh Vivid Chandelier, Synergetics, length 7.5 ft, sterile / EO, 56.54.25...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	Chandelier Infusion Cannula, Synergetics, inc., 20ga, length 7.5 ft, sterile ...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, steri...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	Stiff 25ga Wide Field Endo Illuminator, Synergetics, inc. length 7.5 ft, ster...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	23ga Chandelier Infusion Cannula, Synergetics, inc., length 8.0 ft, sterile /...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	23ga Mid-Field Endo Illuminator, Synergetics length 7.5 ft, sterile / EO, 56....	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	25ga Endo Illuminator, Synergetics, inc., length 7.0 ft, sterile / EO, 56.02....	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	23ga Chow Illuminated Pick, Synergetics, inc., length 7.5 ft, sterile / EO, 5...	Faulty seals on the outer pouch of various, double-pouched, single-use, sterile, ophthalmic devic...	Class II	Synergetics Inc
Dec 9, 2013	BD BACTEC FX 40 instrument, catalog number 442296, manufactured by BD Diagnos...	Improperly functioning component of a diagnostic medical device may cause false negative results ...	Class II	Becton Dickinson & Co.
Dec 9, 2013	Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Nu...	Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.	Class II	Gambro Renal Products, Incorporated
Dec 9, 2013	PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT) U...	Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presen...	Class II	DePuy Orthopaedics, Inc.
Dec 6, 2013	Stryker CMF Customized Implant Kit X-Large; 5444-0-401 X-Large Implant (2) ...	Stryker received a report from the field that an incorrect patient-specific Simplex P CMF Customi...	Class II	Stryker Howmedica Osteonics Corp.
Dec 6, 2013	MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Pr...	Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Cathet...	Class II	Bard Access Systems
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 6, 2013	Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) Catal...	The housing to the Pump's driveline connector became partially or fully separated from the front ...	Class I	HeartWare Inc
Dec 6, 2013	*REF 606-01-05*OPTEFORM Allograft Paste 5 cc, bone void filler of bony de...	RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may cont...	Class II	RTI Surgical, Inc.
Dec 6, 2013	Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone...	Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Cathet...	Class II	Bard Access Systems
Dec 6, 2013	Catheter, Continuous Flush The Merit Microcatheter is intended for general i...	Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a gr...	Class II	Merit Medical Systems, Inc.
Dec 6, 2013	Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4...	The Color Cuff¿ Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorr...	Class II	Stryker Instruments Div. of Stryker 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	GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intende...	Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ...	Class II	GE Healthcare, LLC
Dec 5, 2013	Symmetry and CODMAN brands, QUAD-LOCK Sterilization Container. Sterilization ...	The Quad-Lock Sterilization Container System may not maintain an effective sterile barrier.	Class II	Symmetry Medical/SSI
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 5, 2013	Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 ...	X-ray system C-arm casting may loosen and fall	Class II	Philips Medical Systems, Inc.
Dec 5, 2013	Integra Cusa Excel Rx Only CEM" Nosecone for CUSA¿ Excel System Produc...	The blue COAG button on the CUSA Excel CEM nosecone could stick in the 'activated' position.	Class II	Integra LifeSciences Corp.
Dec 5, 2013	GEMINI TF Big Bore PET/CT, Computer Tomography System, Philips Healthcare Sys...	The TF Big Bore patient table experienced mechanical binding during horizontal table motion resul...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 5, 2013	Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic...	Complaints were received regarding variability in recovery of QC and patient results with certain...	Class II	Siemens Healthcare Diagnostics, Inc.
Dec 5, 2013	Compressor Mini To provide a supply of dry, filtered compressed air for a ...	Maquet Compressor Mini may deliver compressed air at a temperature higher than specified.	Class II	Maquet Cardiovascular Us Sales, Llc
Dec 5, 2013	GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: Th...	Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ...	Class II	GE Healthcare, LLC
Dec 5, 2013	SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthc...	Intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG cable ...	Class II	GE Healthcare, LLC
Dec 5, 2013	Siemens Artis Q and Artis Q biplane systems Product Usage: Intervention...	There exists the possibility that during clinical operation, a breakdown of the x-ray tube could ...	Class II	Siemens Medical Solutions USA, Inc
Dec 4, 2013	Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brillianc...	Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical ...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 4, 2013	Invivo Corporation Expression Information Portal (Model IP5) is intended to b...	Invivo Corporation located at 12151 Research Parkway, Orlando, FL 32826 is recalling the Expressi...	Class II	Invivo Corporation
Dec 4, 2013	CP5 centrifugal pump system Product Usage: The Stockert S5/ Sorin C5 Syst...	Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump syste...	Class II	Sorin Group Deutschland GmbH
Dec 4, 2013	Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, m...	Internal testing of the Proteus 235 Proton Therapy System revealed incorrect dose rate calculatio...	Class II	Ion Beam Applications S.A.
Dec 4, 2013	ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distribu...	The recalling firm determined that visual inspections of the fork joints behind the detector that...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 4, 2013	Diagnostic imaging systems (GEMINI LXL Model #882412, TruFlight Select Model ...	The PET Reconstruction Server (PRS) database may randomly lock up after the low dose CT acquisiti...	Class II	Philips Medical Systems (Cleveland) Inc
Dec 4, 2013	S5/C5 Heart-lung machine Product Usage: The StOckert S5/ Sorin C5 System ...	Sorin is initiating a field correction on S5/C5 Heart-lung machine and CP5 centrifugal pump syste...	Class II	Sorin Group Deutschland GmbH
Dec 3, 2013	Lumbar Extension Machine for Physical Therapy	Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on...	Class II	MedX Holdings, Inc.
Dec 3, 2013	ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Editio...	Baxter Healthcare Corporation is issuing a voluntary correction for ABACUS Total parenteral Nutri...	Class II	Baxter Corporation Englewood
Dec 3, 2013	Cervical Extension Machine for Physical Therapy	Review of DHRs revealed that HiPot, Continuity, load and friction re-testing was not completed on...	Class II	MedX Holdings, Inc.
Dec 3, 2013	Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a meth...	The Irrigation Clips were assembled with the incorrect (smaller) clips.	Class II	The Anspach Effort, 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 29, 2013	steroEOS Workstation with software versions: 1.3, 1.4 and 1.5 used in process...	Error copying information to the clinical file and to the report when two 3D models are opened si...	Class II	EOS Imaging
Nov 27, 2013	GE Healthcare Carescape Patient Data Module The Patient Data Module (PDM)...	GE Healthcare has recently become aware of a potential safety issue due to intermittent failure o...	Class II	GE Healthcare, LLC
Nov 27, 2013	GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Patient Monitors, Dash Port...	GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor and Dash...	Class II	GE Healthcare, LLC
Nov 26, 2013	Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver...	Orthofix received 6 complaints which resulted in a reportable events due to extended surgical tim...	Class II	Orthofix, Inc.
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.

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.