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Browse Device Recalls

1,550 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,550 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 1,550 FDA device recalls in 2012.

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DateProductReasonClassFirm
Dec 31, 2012 Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T... RhMK product fungal contamination. Class III Diagnostic Hybrids Inc
Dec 28, 2012 Creatinine, Part Numbers OSR6178, OSR6678 Product Usage: System reag... Beckman Coulter is including additional information and instructions in the Creatinine (OSR6x78) ... Class II Beckman Coulter Inc.
Dec 28, 2012 CELLTRACKS ANALYZER II (Software Version 2.5.1 & Below. Product Usage: ... Veridex, LLC has received a report that a patient's demographics were incorrectly associated with... Class II Veridex, LLC
Dec 28, 2012 CELLTRACKS AUTOPREP System (Software Version 2.4.1 & Below. Product Usag... Veridex, LLC has received a report that a patient's demographics were incorrectly associated with... Class II Veridex, LLC
Dec 27, 2012 UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalog No. 13910... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 CONMED(R) ELECTROSURGICAL SAFETY HOLSTER, Disposable Safety Holster, REF/Cata... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 TUR/Endoscopic Cable, 10 feet (3.05 mm), REF/Catalog No. 135171, Disposable, ... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - SHARP, Disposable Hyfrecator(R) Tip... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade, REF/Catalo... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 Electrosurgical Tip Cleaner, REF/Catalog No. 138029, Single Use, Sterile, Rx ... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 1 inch Coated Needle with Extended Insulati... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode, 1 inch Coated Blade, REF/Catalog No. 13910... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, Disposable Hyfrecator(R) Tip... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 ABC(R) NOZZLE, Single Patient Use Nozzle, (For use with 130500 Reusable ABC(R... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 ELECTROSURGICAL ENT NEEDLE ELECTRODE, 6 inch with Extended Insulation, REF/Ca... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 4 inch Coated Blade with Extended Insulatio... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 Goldvac(TM) UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extend... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 Goldvac(TM) UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extend... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) HeartWare, Inc. of Miami Lakes, FL is recalling their Ventricular Assist System due to the loosen... Class II Heartware Inc
Dec 27, 2012 UltraClean(R) Accessory Electrode 1 inch Coated Blade with Extended Insulatio... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 Goldvac(TM) UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalo... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 1 inch Coated Needle, REF/Catalog No. 1391... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 Stryker XIA 3 Iliac Screwdriver, 3-PCS. The XIA 3 Iliac Screwdriver is u... Surgeons have experienced unthreading of the screwdrivers outer shafts during use. Class II Stryker Spine
Dec 27, 2012 UltraClean(R) Accessory Electrode 4 inch Coated Blade, REF/Catalog No. 13911... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 6 inch Coated Blade with Extended Insulatio... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 27, 2012 UltraClean(R) Accessory Electrode 6 inch Coated Needle with Extended Insulati... ConMed received complaints of some devices which had broken through the seal of the sterile pouch... Class II ConMed Corporation
Dec 26, 2012 Maquet ELS Cannula 15 FR. Used for extracorporeal membrane oxygenation (ECMO)... ELS 15 Fr Cannula could potentially contain an occluded arterial lumen. Class II Maquet Cardiovascular Us Sales, Llc
Dec 25, 2012 BacT/ALERT SA Blood Culture Bottle. The BacT/ALERT SA reagent bottle is in... BacT/ALERT SA Culture Bottle lot 1031866 may contain bottles with uncured sensors. Class II bioMerieux, Inc.
Dec 21, 2012 MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integ... Integra determined there is a possibility that the Base Units may break during use. Class II Integra LifeSciences Corp.
Dec 21, 2012 OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactur... There is no evidence that a visual inspection was performed on one tray of coverslips. Possibilit... Class III Hitachi Chemical Diagnostics Inc
Dec 21, 2012 1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses. T... Limited number of individual contact lens packages may not have been completely sealed. Class II Johnson & Johnson Vision Care, Inc.
Dec 21, 2012 nordicBrainEX Product Usage: nordicBrainEx is an image processing softwar... There is an error related to the relative geometry between fiber tracts in a fiber group and imag... Class II NordicNeuroLab AS
Dec 21, 2012 ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact... Limited number of individual contact lens packages may not have been completely sealed. Class II Johnson & Johnson Vision Care, Inc.
Dec 20, 2012 ELEKTA MOSAIQ SW version below 2.41 Product Usage: The intended use of th... A potential safety risk with the MOSAIQ Oncology Information System that has been identified by... Class II Siemens Medical Solutions USA, Inc
Dec 20, 2012 Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog N... Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use. Class II Stryker Howmedica Osteonics Corp.
Dec 20, 2012 Brilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and ... Philips Healthcare received reports from the field stating the patient table on a system had an u... Class II Philips Medical Systems (Cleveland) Inc
Dec 20, 2012 Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The... Siemens Healthcare Diagnostics has received complaints of IRON calibrations outside of acceptable... Class III Siemens Healthcare Diagnostics, Inc.
Dec 20, 2012 Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035P... A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5". Class II Medisystems a NX Stage Company
Dec 20, 2012 Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in... The analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no ... Class III Siemens Healthcare Diagnostics, Inc.
Dec 20, 2012 FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountai... Firm received complaints of resistance and possible collapse of the distal tip of the FlowGate Ba... Class II Concentric Medical Inc
Dec 20, 2012 CareFusion SmartSite Gravity Blood Set Model 42082E. Used to administer blo... CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separatio... Class II Carefusion 303 Inc
Dec 20, 2012 Medisystems 17 Gauge x 1" inch AV Fistula Needle Product Code: D9-2007MGLB ... Single needle packs in each case ( 10 needles per case) are mislabeled on the pouch as 15 Gauge ... Class II Medisystems a NX Stage Company
Dec 20, 2012 AMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with... Two production orders of these IOLs that contain mislabeled IOLs. Class II Abbott Medical Optics Inc (AMO)
Dec 20, 2012 Ingenuity TF PET/CT. Diagnostic imaging system that combines Positron Emis... Issues have been detected in the Ingenuity TF PET/CT currently running software version 4.0.60605... Class II Philips Medical Systems (Cleveland) Inc
Dec 20, 2012 HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L. The Endocare CryoP... The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has t... Class II Healthtronics, Inc.
Dec 19, 2012 HAMILTON-T1 Ventilator with software versions 1.1.2 or lower. The HAMIL... Analysis of a customer complaint has shown that during ventilation of small pediatric patients wi... Class I Hamilton Medical Inc
Dec 19, 2012 Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reage... Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/C... Class II Siemens Healthcare Diagnostics, Inc.
Dec 19, 2012 Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4... The DICOM tags do not contain sufficient information for XVI to identify the different volumes th... Class II Elekta, Inc.
Dec 19, 2012 Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray... The four screws that secure the patient table top to the carrier became loose, which caused the t... Class II Philips Medical Systems (Cleveland) Inc
Dec 18, 2012 Needle Counters with Blade Disarmer; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacit... Small holes (approximately 1 mm or less) found in device unit level packaging potentially comprom... Class II Cardinal Health

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.