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 |
|---|---|---|---|---|
| Nov 20, 2015 | AMSCO¿ Warming Cabinet. Manufactured by: STERIS Corporation To raise the ... | The firm discovered that information printed on the quick reference magnet is incorrect; specific... | Class II | Steris Corporation |
| Nov 3, 2015 | MicroVue CIC-C1q EIA, Model A001. The MicroVue CIC-C1q EIA is for detection o... | A component of the kit was found to contain bacterial contamination. | Class III | Diagnostic Hybrids, Inc. |
| Nov 3, 2015 | MicroVue SC5b-9 Plus EIA (RUO), Model A020. Research use only (RUO) product. ... | A component of the kit was found to contain bacterial contamination. | Class III | Diagnostic Hybrids, Inc. |
| Nov 3, 2015 | MicroVue SC5b-9 Plus EIA (CE-IVD), Model A029. An enzyme immunoassay for the... | A component of the kit was found to contain bacterial contamination. | Class III | Diagnostic Hybrids, Inc. |
| Oct 29, 2015 | Brilliance 64 Computed Tomography X-ray system | Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 29, 2015 | Brilliance iCT SP Computed Tomography X-ray system | Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 29, 2015 | Ingenuity Core Computed Tomography X-ray system | Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 29, 2015 | Ingenuity Core 128 Computed Tomography X-ray system | Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 29, 2015 | Brilliance iCT Computed Tomography X-ray system | Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 29, 2015 | Ingenuity CT Computed Tomography X-ray system | Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 23, 2015 | HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm, 36cm, 45c... | Complaints of holes in Tyvek which can compromise the sterile barrier provided by the packaging. | Class II | Ethicon Endo-Surgery Inc |
| Sep 14, 2015 | Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce c... | The firm discovered Ring/Dot artifact due to X-ray measurement error. | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 14, 2015 | Ingenuity Flex Computed Tomography X-ray systems. Intended to produce cross... | The firm discovered Ring/Dot artifact due to X-ray measurement error. | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 14, 2015 | Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems.... | The firm discovered Ring/Dot artifact due to X-ray measurement error. | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 14, 2015 | Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to pro... | The firm discovered Ring/Dot artifact due to X-ray measurement error. | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 14, 2015 | Ingenuity Core Computed Tomography X-ray systems. Intended to produce cross-... | The firm discovered Ring/Dot artifact due to X-ray measurement error. | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 14, 2015 | Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-s... | The firm discovered Ring/Dot artifact due to X-ray measurement error. | Class II | Philips Medical Systems (Cleveland) Inc |
| Sep 3, 2015 | AMSCO 400 and AMSCO C Small Steam Sterilizers | In AMSCO Small Steam Sterilizers equipped with the CS-iQ feature, the sterilizer software inadver... | Class III | Steris Corporation |
| Aug 27, 2015 | MRIdian¿ ViewRay¿ Radiation Therapy System, ViewRay¿ Is indicated for ste... | ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling Syst... | Class II | Viewray Incorporated |
| Aug 3, 2015 | Ferno iNX Wheeled Stretcher, Integrated Patient Transport & Loading System ... | Hole elongation in the telescoping load frame channel. A hole elongation could affect the ability... | Class II | Ferno-Washington Inc |
| 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 |
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.