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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.