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
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
Sep 27, 2016 The surgical table is a stand alone unit. Three (3) floor locking cylinders a... The floor locking cylinders contained in the base of the Schaerer 7300 model surgical tables were... Class II Schaerer Medical USA Inc
Sep 27, 2016 Replacement floor locking cylinders for the Schaerer model 7300 surgical tabl... The floor locking cylinders are contained in the base of the Schaerer 7300 model surgical tables.... Class II Schaerer Medical USA Inc
Sep 22, 2016 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip Product ... There is a potential for a component failure of the device which could necessitate medical interv... Class II AtriCure, Inc.
Sep 22, 2016 COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA ... Due to product design and process control, part of the device can separate and remain behind when... Class II AtriCure, Inc.
Sep 1, 2016 VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144 Adhesive border was not sticky enough. Class II CellEra LLC
Aug 24, 2016 Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography... The infant performance test did not meet the test specification for the Infant Head Uniformity te... Class II Philips Medical Systems
Aug 24, 2016 Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X... The infant performance test did not meet the test specification for the Infant Head Uniformity te... Class II Philips Medical Systems
Aug 24, 2016 Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray... The infant performance test did not meet the test specification for the Infant Head Uniformity te... Class II Philips Medical Systems
Aug 24, 2016 Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray... The infant performance test did not meet the test specification for the Infant Head Uniformity te... Class II Philips Medical Systems
Jul 20, 2016 Ingenuity Core128, Model number 728323 Product Usage: Computed Tomography... After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... Class II Philips Medical Systems (Cleveland) Inc
Jul 20, 2016 Ingenuity Core, Model number 728321 Product Usage: Computed Tomography X-... After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... Class II Philips Medical Systems (Cleveland) Inc
Jul 20, 2016 Brilliance 16, Model number 728246 Product Usage: Computed Tomography X-r... After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... Class II Philips Medical Systems (Cleveland) Inc
Jul 20, 2016 Brilliance BigBore Radiology CT Model number 728244 Product Usage: Comput... After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... Class II Philips Medical Systems (Cleveland) Inc
Jul 20, 2016 Brilliance CT Big Bore Oncology, Model number 728243 Product Usage: Compu... After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... Class II Philips Medical Systems (Cleveland) Inc
Jul 20, 2016 Brilliance 64 CT Model number 728231 Product Usage: Computed Tomography X... After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... Class II Philips Medical Systems (Cleveland) Inc
Jul 20, 2016 Brilliance CT 16 Power, Model number 728240 Product Usage: Computed Tomog... After upgrading to 3.6.7 software version via FCO72800643, during reconstruction of gated helical... Class II Philips Medical Systems (Cleveland) Inc
Jul 15, 2016 Endoscopic Articulating Linear Cutter, 38ATW35. VASCULAR/THIN 35MM The ENDOP... Quality control identified a component issue where the pinion gear in the device could fail under... Class II Ethicon Endo-Surgery Inc
Jul 15, 2016 Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM. The ENDOPATH E... Quality control identified a component issue where the pinion gear in the device could fail under... Class II Ethicon Endo-Surgery Inc
Jul 14, 2016 MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specifi... There is a possibility of low volume and/or leaking standard bottles. Class II Diagnostic Hybrids, Inc.
Jul 4, 2016 Zimmer¿ Air Dermatome II Handpiece Loaner, item number 01-8851-001-00. Device... Zimmer Biomet Surgical has received product complaints reporting that the surface coating applied... Class II Zimmer Surgical 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.