Browse Device Recalls

1,062 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,062 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 1,062 FDA device recalls in OH.

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DateProductReasonClassFirm
Aug 11, 2014 Prime Care ¿ Transcend Mattress, Prime Care ¿ Transcend Perimeter Mattress, P... The firm found that the top cover of the mattresses were delaminating. Class II Primus Medical LLC
Jul 28, 2014 RADIANCE v. 2.4X, 2.5X and 2.6X Product Usage: RADIANCE is a data process... Class II Radiometer America Inc
Jul 27, 2014 IntelliSpace Portal (ISP) DX/HX/EX, IntelliSpace Portal (ISP) IX, and Intelli... The following software issues have been identified in the affected products. Problem 1: When reo... Class II Philips Medical Systems (Cleveland) Inc
Jul 11, 2014 Serrated Soft Tissue Shields. Orthopedic surgical instruments, part of the S... Revision B of the tissue shields of the device was 7 mm longer than the previous design. Class II X Spine Systems Inc
Jun 30, 2014 Reliance 1227 Cart and Utensil Washer/Disinfector Product Usage: Usage: ... STERIS has identified that deformation of the washers door handle pin may occur when the door ha... Class III Steris Corporation
Jun 27, 2014 The STERIS 4085 General Surgical Table Product Usage: is an electro-hydra... STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifol... Class II Steris Corporation
Jun 25, 2014 Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquat... The Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. This may result... Class II Invacare Corporation
Jun 24, 2014 MK5 NX Controller--Wheelchair controller M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were ... Class II Invacare Corporation
Jun 23, 2014 BrightView XCT: product code 882482, BrightView X- upgraded with the XCT Flat... Flat Panel Display (FPD) failed to remain securely locked in the deployed position. Class II Philips Medical Systems (Cleveland) Inc
Jun 18, 2014 GEMINI TF PET/CT16: 882470, GEMINI TF PET/CT 64: 882471, GEMINI TF Big Bore: ... When beginning a procedure to start the gantry and CT Host, a Close Estop message may appear to ... Class II Philips Medical Systems (Cleveland) Inc
Apr 25, 2014 Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usag... The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a ... Class II Hitachi Medical Systems America Inc
Apr 22, 2014 illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 ... Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a res... Class II Meridian Bioscience Inc
Apr 7, 2014 Model RG3000 and RG4000 Series Valve Integrated Pressure Regulator (VIPR) Separation events have occurred, including the VIPR separating from the Aluminum cylinder. Class II Western / Scott Fetzer Company
Apr 4, 2014 Vertical Spring Arm for Single or Dual Monitor Mount (Harmony LL 500 and Harm... Potential for the welded seam in affected monitor spring arms to crack and/or break. Class II Steris Corporation
Apr 1, 2014 Philips Medical Systems Computed Tomography X-ray systems (Brilliance CT seri... A customer reported that the table top had become free floating. A Field Service Engineer (FSE) ... Class II Philips Medical Systems (Cleveland) Inc
Mar 27, 2014 Brilliance CT 16, Brilliance CT 64, Brilliance CT Big Bore Oncology, Brillian... Block assembly-lock stop subframe of service latch was not manufactured to engineering specificat... Class II Philips Medical Systems (Cleveland) Inc
Mar 20, 2014 Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain manage... The external power supply input is overheating at the connection to the freezer. Class II Global Cooling Inc
Mar 11, 2014 IntelliSpace Portal (ISP), (ISP DX/HX/EX, Model number 881001; ISP IX, Model ... During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Corr... Class II Philips Medical Systems (Cleveland) Inc
Mar 10, 2014 Nuclear gamma cameras (ADAC Vertex Plus, ADAC Solus, ADAC Vertex V60 & ADAC V... Slippage of the radius drive belt in the relative 180 degree orientation of the superior position... Class II Philips Medical Systems (Cleveland) Inc
Mar 6, 2014 Ingenuity Core 128, Computed Tomography X-ray systems, Philips Medical System... A customer reported that after upgrading to software version 3.5.5 from 3.5.4, reconstructions wo... Class II Philips Medical Systems (Cleveland) Inc
Feb 10, 2014 The Thermedx Fluid Management System is designed to provide irrigation fluids... A vendor changed the manufacturing process of a component used in the canister ring that may affe... Class II Thermedx LLC
Feb 3, 2014 OneTray Sealed Sterilization Containers Product Usage: A rigid sterilizat... The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at ... Class II Innovative Sterlization Technologies LLC
Jan 23, 2014 Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive,... The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. Class II Atricure Inc
Jan 8, 2014 115 V Blanketrol II, Model 222S Hyper-Hypothermia System . Used to lower or ... The incorrect voltage component was placed into the device during manufacturing. This may make th... Class II Cincinnati Sub-Zero Products Inc
Dec 19, 2013 Single and Dual use Emission Computer Tomography gamma cameras (BrightView XC... Three problems were reported to the firm: When positioning for a relative 180 degree non circu... Class II Philips Medical Systems (Cleveland) Inc
Dec 19, 2013 Brilliance CT Big Bore Oncology Whole Body Computed Tomography X-Ray System ... During internal testing, the Brilliance CT Big Bore was found to be out of tolerance for radio fr... Class II Philips Medical Systems (Cleveland) Inc
Dec 19, 2013 VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, ... STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY¿ SixCe... Class II Steris Corporation
Dec 11, 2013 Latex Dental Dams labeled as Non-Latex Dental Dams Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. Dur... Class II Coltene Whaledent Inc
Dec 9, 2013 Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips... Patient images exhibited ring artifacts. Class II Philips Medical Systems (Cleveland) Inc
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 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 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
Nov 21, 2013 SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS ... Customers indicated fluctuations in environmental conditions sites and gradual degradation/deform... Class II Steris Corporation
Oct 18, 2013 AMSCO¿ Evolution¿ steam sterilizer Transfer Carriage. Product Usage: Mob... The firm discovered that unlatching can occur when overloaded transfer carriages are pulled or ma... Class II Steris Corporation
Oct 15, 2013 ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 Br¿nsh¿j, Denmark ... RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative b... Class II Radiometer America Inc
Oct 11, 2013 Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Br... If the couch, with the footrest extension attached, is positioned where the table travel is withi... Class II Philips Medical Systems (Cleveland) Inc
Sep 30, 2013 Adjustable Gastric Band, packaged alone in transparent PETG inner and outer b... During aging studies, the firm determined that the gastric belts were unable to pass the test req... Class II Ethicon Endo-Surgery Inc
Sep 30, 2013 Adjustable Gastric Band, packaged alone in transparent PETG inner and outer b... During aging studies, the firm determined that the gastric belts were unable to pass the test req... Class II Ethicon Endo-Surgery Inc
Sep 30, 2013 Adjustable Gastric Band, packaged alone in transparent PETG inner and outer b... During aging studies, the firm determined that the gastric belts were unable to pass the test req... Class II Ethicon Endo-Surgery Inc
Sep 10, 2013 VERIFY¿ Dual Species Self-Contained Biological Indicator, Distributed by STER... STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM ... Class II Steris Corporation
Sep 3, 2013 BrightView XCT is a gamma camera for Single Photon Emission Computed Tomograp... Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain... Class II Philips Medical Systems (Cleveland) Inc
Sep 3, 2013 Blanketrol III, Model Number 233, Cincinnati Sub-Zero Products, Inc., 12011 M... During a label review it was discovered that both the Blanketrol III Operations (57201-N) & Opera... Class II Cincinnati Sub-Zero Products Inc
Aug 31, 2013 Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower ... The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocea... Class II Invacare Corporation
Aug 30, 2013 Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brillia... There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with p... Class II Philips Medical Systems (Cleveland) Inc
Aug 29, 2013 Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley... The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle o... Class II Steris Corporation
Aug 16, 2013 Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installa... Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the ev... Class II Philips Medical Systems (Cleveland) Inc
Aug 15, 2013 Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Me... Dr¿ger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained... Class II Steris Corporation
Aug 9, 2013 Sonogage EyeScan, A-Scan Biometer, Product Usage: A-Scan Biometer diagno... During an FDA inspection on 7/15-26/2013, it was discovered that the firm lacked registration and... Class II Sonogage Inc
Aug 7, 2013 Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1... There is a potential for water to collect in the vent pipe elbow in the magnet venting system. W... Class II Philips Medical Systems (Cleveland) 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.