Browse Device Recalls

1,092 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 1,092 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 1,092 FDA device recalls in OH.

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DateProductReasonClassFirm
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
Mar 3, 2011 Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running ... Multiple software defects which could impact the performance or reliability of the system. These... Class II Philips Medical Systems (Cleveland) Inc
Feb 2, 2011 AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus M... The "Retaining washers & Clevis Pins" provided with the AC -powered adjustable hospital beds may ... Class II Primus Medical LLC
Aug 18, 2010 G7 HPLC. Used as an aid in the detection and presumptive identification of... The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performan... Class III Tosoh Bioscience Inc
Feb 17, 2010 A mobile, electro-hydraulically operated, fluoroscopic/C-Arm compatible gener... Customers may be storing objects on the base and/or around the column of the surgical table. Thi... Class II Steris Corporation
Feb 1, 2010 The Handi-Fil Disposable Syringe Fill Tube is a sterile plastic tube, approxi... A report was received from a Japanese distributor regarding a complaint from a hospital customer ... Class II Mallinckrodt Inc
Jan 29, 2010 OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465... The tips of the drivers are breaking while being used to drive the screws into patients. Class II Orthohelix Surgical Designs Inc
Jan 29, 2010 OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465... The tips of the drivers are breaking while being used to drive the screws into patients. Class II Orthohelix Surgical Designs Inc
May 1, 2008 GEMINI PET/CT System, a diagnostic imaging system for fixed or mobile install... The reason for this inspection is to determine if the Spindle Block Servo Controllers on the CT s... Class II Philips Medical Systems (Cleveland) Inc
Jan 9, 2007 No packaging. The device is a computed tomography scanner. Intended to ... When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in te... Class II Philips Medical Systems (Cleveland) Inc
Jun 6, 2006 Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The ... The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 in... Class III Radiometer America Inc
Apr 25, 2006 Brilliance CT (computed tomography) scanners, Big Bore configuration, Model n... Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization appli... Class II Philips Medical Systems (Cleveland) Inc
Dec 27, 2005 Brilliance CT System 6/10/16/16P/40 configuration. No packaging, sold as sin... The system has a gap that can appear between the upper and lower tilt stand covers. The fingers m... 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.