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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 4, 2017 | MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of... | There is a potential for the slope of the standard curve to fail to meet the assay validation req... | Class II | Diagnostic Hybrids, Inc. |
| Mar 31, 2017 | Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM | There is a risk that the pinion gear in the device could fail under extreme use cases. | Class II | Ethicon Endo-Surgery Inc |
| Mar 22, 2017 | AIA-360 Analyzer is capable of performing two methods of immunoassay: an immu... | The firm has become aware of a potential issue with the AIA-360 analyzer that could prevent the t... | Class II | Tosoh Bioscience Inc |
| Mar 9, 2017 | Hemotherm CE, model 400CE, Heater-Cooling Device | Improperly rated fuses were used in the manufacture of the device. | Class II | Cincinnati Sub-Zero Products Inc |
| Mar 8, 2017 | Ferno PROFlexx¿ Model 28Z Chair Cot | The recall was initiated as a result of the detection of an incorrect nut used in manufacturing. | Class II | Ferno-Washington Inc |
| Feb 28, 2017 | Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to s... | The device did not have Revolve Stereo Probe labeling, no product code indicating the size and le... | Class II | Devicor Medical Products Inc |
| Feb 24, 2017 | BrightView SPECT model number 882480 BrightView and BrightView X are gamma c... | The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 24, 2017 | BrightView X 3/8 model number 882478 BrightView and BrightView X are gamma c... | The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... | Class III | Philips Medical Systems (Cleveland) Inc |
| Feb 24, 2017 | BrightView X 3/4 model number 882479 BrightView and BrightView X are gamma c... | The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 24, 2017 | BrightView XCT model number 882482 BrightView and BrightView X are gamma cam... | The brake hub was not engaging with the gear box shaft due to an error in the assembly of compone... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 23, 2017 | Brilliance BigBore Radiology CT - 728244 Computed Tomography X-ray systems i... | Philips identified a 4D CT pulmonary phase issue on Brilliance BigBore Oncology/Radiology CT with... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 23, 2017 | Brilliance BigBore Oncology CT - 728243 Computed Tomography X-ray systems in... | When the user performs a retrospective respiratory gated 4D CT scan with the Bellows pulmonary ga... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 31, 2017 | 882478: BrightView X designed for single or dual detector nuclear imaging acc... | Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door inte... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 31, 2017 | 882482: BrightView XCT 882454 BrightView X upgrade to XCT, designed for singl... | Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door inte... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 31, 2017 | 882480: BrightView designed for single or dual detector nuclear imaging accom... | Four issues: 1. Motion controller problem stops scan and no data image produced. 2. Door inte... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jan 27, 2017 | Hand Foot II, UVB-138. One device per box; device is surrounded by foam inse... | The wiring may allow the lamps to turn on with the key switch rather than the timer. | Class II | National Biological Corp |
| Jan 19, 2017 | AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointesti... | Expired expiration dates are listed on the pouches. | Class III | Applied Medical Technology Inc |
| Jan 19, 2017 | AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Naso... | Expired expiration dates are listed on the pouches. | Class III | Applied Medical Technology Inc |
| Jan 6, 2017 | Hitachi Oasis MRI System - C-Spine Coil | The customer indicated that the coil balun was hot to the touch when removing the coil from the p... | Class II | Hitachi Medical Systems America Inc |
| Jan 5, 2017 | EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra O... | There is a possibility for data to be stored under the wrong patient on the DICOM Server followin... | Class II | Haag-Streit USA Inc |
| Dec 23, 2016 | BrightView XCT | The intended use listed in the English and localized language IFUs for BrightView XCT systems did... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 23, 2016 | Brilliance iCT | During a retrospective review of production documentation it was observed that the M6 Rotor Count... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 23, 2016 | BrightView X upgraded to XCT 882454 | The intended use listed in the English and localized language IFUs for BrightView XCT systems did... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 22, 2016 | Keyspan High-High Speed USB to Serial Adapter Product Usage: The Reportin... | Power outages causes reporting software to shutdown. | Class II | Tosoh Smd Inc |
| Dec 16, 2016 | IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spec... | Multiple issues have caused the device to result in CT rescans or incorrect scan location or misr... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 13, 2016 | Roth Net Polyp Retrieval | The firm was notified that the expiration date on the outer carton is different than the expirati... | Class III | US Endoscopy Group Inc |
| Dec 2, 2016 | Foot Section - BAR5490IVC | A quality issue with the junction box used in the bariatric bed junction that may omit sparks and... | Class II | Invacare Corporation |
| Dec 2, 2016 | Bariatric Bed - BAR600IVC | The junction box used in the bariatric bed may emit sparks and result in a fire. | Class II | Invacare Corporation |
| Dec 2, 2016 | Junction Box - 1104343 and 1193560 | A quality issue with the junction box used in the bariatric bed junction that may omit sparks and... | Class II | Invacare Corporation |
| Dec 2, 2016 | Bariatric Bed - BARPKG-IVC 1633 | A quality issue with the junction box used in the bariatric bed junction that may omit sparks and... | Class II | Invacare Corporation |
| Nov 30, 2016 | AtriClip" LAA Exclusion System with preloaded Gillinov-Cosgrove" Clip - A sin... | A complaint of the PRO2 jaw breaking prior to surgery being performed. | Class II | AtriCure, Inc. |
| Nov 25, 2016 | Brilliance iCT Product Usage: Computed Tomography X-ray systems intended... | Failure to correctly document the installation of four M12 Bolts into the system rotor. | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 18, 2016 | FV-RF (Clinix RF Plus) Product Usage: A Stationary X-ray System, a device... | There's a potential for liquid penetration into the back side of the front control panel of the X... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 14, 2016 | IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cr... | A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Application... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 14, 2016 | Philips Spectral CT Applications supports viewing and analysis of images at e... | A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Application... | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Brilliance 64 728232 Computed Tomography X-ray systems intended to produce c... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Ingenuity Core 128 728323 | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Ingenuity CT 728326 Computed Tomography X-ray systems intended to produce cr... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Ingenuity Core 728321 Computed Tomography X-ray systems intended to produce ... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 12, 2016 | Brilliance 64 728231 Computed Tomography X-ray systems intended to produce c... | Software error due to the filament on timer | Class II | Philips Medical Systems (Cleveland) Inc |
| Nov 8, 2016 | PREMIER EHEC and PREMIER EHEC Bulk. | Internal testing has demonstrated that the indicated kit lots produce false positive results when... | Class II | Meridian Bioscience Inc |
| Nov 7, 2016 | The Hemotherm 400CE 115v, containing power board p/n 39945 | The device may not maintain water flow or temperature control. | Class II | Cincinnati Sub-Zero Products Inc |
| Oct 26, 2016 | Quidel MicroVue Intact PTH EIA, Model 8044. An enzyme immunoassay for the qu... | There may be a loss of separation between Calibrators A and B which may impact the assay calibrat... | Class III | Diagnostic Hybrids, Inc. |
| Oct 13, 2016 | Ingenuity CT Computed Tomography X-ray system, Model 728326 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | Ingenuity Core 128 Computed Tomography X-ray system, Model 728323 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | IQon Spectral CT Computed Tomography X-ray system, Model 728332 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | Brilliance ICT SP Computed Tomography X-ray system, Model 728311 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | Ingenuity Core Computed Tomography X-ray system, Model 728321 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 13, 2016 | Brilliance iCT Computed Tomography X-ray system, Model 728306 | The product label does not include the correct current rating. | Class III | Philips Medical Systems (Cleveland) Inc |
| Oct 5, 2016 | Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS) The... | The Drager Pendula spring arm device has a set of screws located on the spring arm that were not... | Class II | Steris Corporation |
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.