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
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.