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 |
|---|---|---|---|---|
| Jul 23, 2015 | Ingenuity TF PET/MR, Diagnostic Imaging System , Philips Medical Systems | Philips Healthcare has become aware of a problem in which the Ingenuity TF PET/MR PET Reconstruct... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 14, 2015 | Histolock Resection Device, US Endoscopy. An electrosurgical device desig... | The company has determined the sterility cannot be assured for the affected lot. | Class II | US Endoscopy Group Inc |
| Jul 1, 2015 | GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems ar... | Philips has identified four (4) software defects in the Tumor LOC software application that may p... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 1, 2015 | GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a ... | Philips has identified four (4) software defects in the Tumor LOC software application that may p... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 1, 2015 | GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems a... | Philips has identified four (4) software defects in the Tumor LOC software application that may p... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 1, 2015 | GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging System... | Philips has identified four (4) software defects in the Tumor LOC software application that may p... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 1, 2015 | GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Syste... | Philips has identified four (4) software defects in the Tumor LOC software application that may p... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 1, 2015 | GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging System... | Philips has identified four (4) software defects in the Tumor LOC software application that may p... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 1, 2015 | GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging System... | Philips has identified four (4) software defects in the Tumor LOC software application that may p... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 30, 2015 | Hitachi Scenaria Computed Tomography System Hitachi Medical Systems America,... | The firm discovered that the centrifugal force applied to the power supply may cause it to fail o... | Class II | Hitachi Medical Systems America Inc |
| Jun 24, 2015 | 18inch Dual Port/Single Bladder Disposable Tourniquet Cuff, Zimmer Surgical, ... | The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions a... | Class II | Zimmer Surgical Inc |
| Jun 24, 2015 | 30inch Dual Port/Single Bladder Disposable Tourniquet Cuff with PLC, Zimmer S... | The inside of the folded Instructions For Use (IFU) pamphlet was missing the usage instructions a... | Class II | Zimmer Surgical Inc |
| Jun 3, 2015 | Alaris Medley LVP Bezel Assembly. Intended use to hold platen assembly and... | Administration of inappropriate quantities of fluid can result, with the potential to cause injur... | Class I | Elite Biomedical Solutions LLC |
| Jun 3, 2015 | Alaris Medley LVP Frame Membrane. Intended use to hold platen assembly and... | Administration of inappropriate quantities of fluid can result, with the potential to cause injur... | Class I | Elite Biomedical Solutions LLC |
| May 13, 2015 | SEDASYS Computer-Assisted Personalized Sedation System, SEDPRU01. An inte... | Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have ... | Class I | Ethicon Endo-Surgery Inc |
| May 7, 2015 | Treatment Planning and Delivery System Software version 3.6. ViewRay. Ind... | The software was failing to determine new patient locations if imaging is not enabled during trea... | Class II | Viewray Incorporated |
| May 4, 2015 | Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID P... | Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Se... | Class II | Smiths Medical Asd Inc |
| May 1, 2015 | Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled St... | The firm discovered an improperly installed set screw in one caster arm assembly on a unit in pro... | Class II | Ferno-Washington Inc |
| Apr 21, 2015 | Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer... | Devices were placed in a shipper carton without the appropriate number of the Instructions for Us... | Class III | Zimmer Surgical Inc |
| Apr 20, 2015 | Roscoe Mini Neb Compressor User Manual for the NEB-ROS Product Usage: Inh... | Roscoe Medical has recently identified the need to update its user manual with additional warning... | Class II | Compass Health Brands |
| Apr 16, 2015 | Hitachi Echelon Oval MRI System | Image data transferred from the MRI system to a workstation showed errors on the slice position r... | Class II | Hitachi Medical Systems America Inc |
| Apr 16, 2015 | Hitachi Oasis MRI System | Image data transferred from the MRI system to a workstation showed errors on the slice position r... | Class II | Hitachi Medical Systems America Inc |
| Apr 16, 2015 | Hitachi Echelon MRI System | Image data transferred from the MRI system to a workstation showed errors on the slice position r... | Class II | Hitachi Medical Systems America Inc |
| Apr 13, 2015 | Brilliance iCT Computed Tomography X-ray system | A calibrated torque wrench malfunctioned at the supplier leading to possible incorrect torque of ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 7, 2015 | Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine System... | The Continuous Radius Rod should measure 50mm in length but actually measures 45mm in length. | Class II | X Spine Systems Inc |
| Apr 1, 2015 | Patient Handling System (Motion Control Software), Product Usage: Indica... | ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS... | Class II | Viewray Incorporated |
| Mar 17, 2015 | Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems... | A head holder released for use with other CT systems but not yet qualified for use on the Ingenui... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 17, 2015 | Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems | A head holder released for use with other CT systems but not yet qualified for use on the Ingenui... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 17, 2015 | Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. ... | A head holder released for use with other CT systems but not yet qualified for use on the Ingenui... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | Brilliance CT 40. Computed Tomography X-ray systems intended to produce cr... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to p... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | Ingenuity CT. Computed Tomography X-ray systems intended to produce cross-... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intende... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | Brilliance CT 64. Computed Tomography X-ray systems intended to produce cr... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | Brilliance CT 6 Air. Computed Tomography X-ray systems intended to produce... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produc... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produc... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | Brilliance CT 16 Power. Computed Tomography X-ray systems intended to prod... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | Brilliance iCT. Computed Tomography X-ray systems intended to produce cros... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 16, 2015 | Brilliance CT 16 Water. Computed Tomography X-ray systems intended to prod... | The firm was informed that while raising the patient couch on the system to perform an exam, the ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 13, 2015 | Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, AD... | During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 11, 2015 | Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imagin... | It was noticed that the spectroscopy voxel map did not align with the anatomical images of the ph... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 11, 2015 | Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation devi... | One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x... | Class II | X Spine Systems Inc |
| Mar 11, 2015 | Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC ... | The firm was notified by a customer that the collimator exchange carriage and the collimator stor... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 10, 2015 | Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign b... | A wire component on the distal grasping assembly of the device became detached.. | Class II | US Endoscopy Group Inc |
| Mar 6, 2015 | Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devi... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity TF (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | BrightView X (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | CardioMD III (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | 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.