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
Oct 25, 2012 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization ... The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed ... Class III Volk Optical Inc
Oct 24, 2012 Philips Medical Systems, GEMINI LXL - Model #882412; GEMINI TF 16 - Model #88... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... Class II Philips Medical Systems (Cleveland) Inc
Oct 24, 2012 Philips Medical Systems, GEMINI TF Big Bore, Model #882476, Positron Emission... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... Class II Philips Medical Systems (Cleveland) Inc
Oct 24, 2012 Philips Medical Systems, Extended Brilliance Workspace (EBW) X-Ray Scanners, ... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... Class II Philips Medical Systems (Cleveland) Inc
Oct 24, 2012 Philips Medical Systems, Brilliance Computed Tomography (CT) X-Ray Scanners, ... Software anomaly. Philips determined that the TumorLOC software program for the referenced PET/C... Class II Philips Medical Systems (Cleveland) Inc
Oct 8, 2012 Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intend... RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The en... Class II Radiometer America Inc
Oct 4, 2012 PSX PROXIMATE Skin Staple Extractor, ETHICON ENDO-SURGERY, LLC. For routi... Damage to the packaging may have compromised the sterility of the device. Class II Ethicon Endo-Surgery Inc
Sep 28, 2012 Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model ... Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to s... Class II Philips Medical Systems (Cleveland) Inc
Sep 28, 2012 Philips Medical System Extended Brilliance Workspace (EBW), Computed Tomograp... Incorrect values may be displayed. Philips is issuing a software update (version 4.5.5) to the E... Class II Philips Medical Systems (Cleveland) Inc
Sep 18, 2012 Mx8000 IDT Whole Body Computed Tomography X-ray system Distributed by Philips... The low contrast pins in the Image Quality (IQ) phantom deteriorates over time. This prevents th... Class II Philips Medical Systems (Cleveland) Inc
Sep 11, 2012 Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 P... Philips was notified that when performing post processing with the Brilliance Workspace Portal pl... Class II Philips Medical Systems (Cleveland) Inc
Sep 10, 2012 Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to... The potential exists for the wheel to rotate freely despite engagement of hub brake. Class II Invacare Corporation
Aug 31, 2012 The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system i... Philips Healthcare received a complaint stating the system opens e-stop while sitting idle causin... Class II Philips Medical Systems (Cleveland) Inc
Aug 28, 2012 The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole B... Philips was notified that the system logout in software version 2.3.6 is now longer and may somet... Class III Philips Medical Systems (Cleveland) Inc
Aug 24, 2012 MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT S... On August 24, 2012 the firm recalled the MX 16-slice after discovering that a bolt which attaches... Class II Philips Medical Systems (Cleveland) Inc
Aug 21, 2012 Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual ... A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumu... Class II Philips Medical Systems (Cleveland) Inc
Aug 17, 2012 Octopus 101 Perimeter; PeriTrend Software Analysis A perimeter is a device... The firm recalled the device after learning of a possible deviation in the stimulus luminance of ... Class II Haag-Streit USA Inc
Aug 10, 2012 QKC1692E The QKC1692E Quick Connect device connects endoscopes to the ste... STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was una... Class II Steris Corporation
Aug 9, 2012 AmeriWater MRO Dialysis RO+ System, AmeriWater 1303 Stanley Avenue, Dayton, O... The firm was notified that a malfunction of the device was caused by an incorrect fuse 32 volt 15... Class II AmeriWater Inc
Aug 8, 2012 Positron Emission Tomography (PET) and X-ray Computed Tomography, GEMINI TF 1... Philips became aware of an issue relating to a UPS battery cabinet that appeared to have burned a... Class II Philips Medical Systems (Cleveland) Inc
Aug 6, 2012 Invacare¿ I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporati... On August 6, 2012, Invacare voluntarily recalled the Invacare¿ I-Fit" Shower Chair (Models 9780, ... Class II Invacare Corporation
Aug 3, 2012 Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: ... Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXI... Class I Ethicon Endo-Surgery Inc
Aug 3, 2012 The Brilliance 6, 10, 16, 40, 64 and CT Big Bore are Computed Tomography X-Ra... The patient support may move in an unintended manner if the foot switch cover becomes damaged and... Class II Philips Medical Systems (Cleveland) Inc
Aug 2, 2012 100 ft roll of tubing inside a cardboard box. Medical devices are sealed into... On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it ... Class III Steris Corporation
Aug 1, 2012 The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Ste... The firm initiated a recall after complaint investigations revealed that when the units are left ... Class II Steris Corporation
Jul 27, 2012 TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scann... On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not function... Class II Quality Electrodynamics LLC
Jul 23, 2012 VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek Sys... Review of instrument software databases and investigation of two customer reports determined that... Class III Trek Diagnostic Systems
Jul 18, 2012 The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray S... 1. The current system design of software version 4.0.0xx379 does not prevent the system from scan... Class II Philips Medical Systems (Cleveland) Inc
Jul 15, 2012 Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a ver... The firm voluntarily recalled the device after they discovered that the sterilization recommendat... Class II Lucero Medical LLC
Jul 14, 2012 The Reliance 130 and 130L Cart Washer/Disinfector is a high capacity mechanic... To ensure that users are properly operating the Reliance 130 and 130L Cart Washers, a door close ... Class II Steris Corporation
Jul 5, 2012 The ABL software version 6.12 for the ABL800 analyzer. The analyzers are inte... A customer has reported an error on an ABL8xx configured to a Hospital Information System using t... Class II Radiometer America Inc
Jul 5, 2012 The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyze... A customer has reported an error on an ABL8xx configured to a Hospital Information System using t... Class II Radiometer America Inc
Jul 5, 2012 ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for... A customer has reported an error on an ABL8xx configured to a Hospital Information System using t... Class II Radiometer America Inc
Jul 3, 2012 Verify¿ Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 932... STERIS has learned that the Verify Bowie Dick Test Cards are not performing to product specificat... Class II Steris Corporation
Jul 2, 2012 Philips Brilliance 6, 16, 40, 64, Big Bore, iCT and iCT SP are Computed Tomog... Philips Healthcare was notified that several of the sixteen bolts securing the brackets which sup... Class II Philips Medical Systems (Cleveland) Inc
Jun 15, 2012 Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled... Hitachi discovered a software error with a feature called Multi-Planar Reconstruction (MPR). MPR... Class II Hitachi Medical Systems America Inc
May 23, 2012 Intellispace Portal software. Intellispace Portal is a multimodality thin ... Philips is issuing a software update to the Intellispace Portal systems to address a number of no... Class II Philips Medical Systems (Cleveland) Inc
May 23, 2012 IntelliSpace Portal software and Extended Brillance Workspace software In... The Intellispace Portal software and Extended Brillance Workspace software may have significantly... Class II Philips Medical Systems (Cleveland) Inc
May 22, 2012 Intellispace Portal software Product Usage: Intellispace Portal is a mult... In the Multi-Modality Tumor Tracking application, when changing the contours of the lesion using ... Class II Philips Medical Systems (Cleveland) Inc
May 7, 2012 The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended ... Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems cur... Class II Philips Medical Systems (Cleveland) Inc
May 4, 2012 Hitachi Scenaria CT System Software Product Usage: The Scenaria system is... Hitachi discovered a software error in the Reconstruction Status function that creates a potentia... Class II Hitachi Medical Systems America Inc
Apr 16, 2012 Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs... The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wh... Class II Invacare Corporation
Apr 6, 2012 STERIS 5085 and 5085 SRT Surgical Tables, Product Usage: The 5085 is a... STERIS has learned from Customer feedback and field service experience that damage from external ... Class II Steris Corporation
Apr 6, 2012 TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Mo... Invacare Corporation decided to recall the product because of a potential risk of fire and seriou... Class II Invacare Corporation
Feb 23, 2012 Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN VI... Some combinations of Calibrator lots and AlA PACKS resulted in Calibrator #6 not giving a value, ... Class II Tosoh Bioscience Inc
Feb 8, 2012 The finger cots are made out of natural rubber. They are disposable products... The firm is initiating a field correction because the product(s) were missing the Latex Warning L... Class II Afassco Inc
Dec 22, 2011 Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc... US Endoscopy received five complaints which noted difficulty in deploying the cytology brush thro... Class II US Endoscopy Group Inc
Nov 14, 2011 Endoscopic retrieval device. The disposable Raptor grasping device in inte... When the outer catheter is either coiled or in a contorted configuration outside of the endoscope... Class II US Endoscopy Group Inc
Sep 1, 2011 The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems inte... During a Field Test (a customer external evaluation period), the customer detected a problem in t... Class II Philips Medical Systems (Cleveland) Inc
Mar 7, 2011 Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, ... The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a re... 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.