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 |
|---|---|---|---|---|
| Nov 16, 2018 | Presource Kit Total Joint Pack containing a double-wrapped basin component. ... | The double wrapping of this custom kit basin set is not supported by the current sterility assura... | Class II | Cardinal Health Inc. |
| Nov 16, 2018 | Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P ... | Invacare has identified via customer complaints, the potential for the mounting bolt connecting t... | Class II | Invacare Corporation |
| Oct 18, 2018 | Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomograph... | There is a potential for separation of fiberglass resin which may cause the gantry front cover an... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 18, 2018 | Brilliance 10 Slice (Air), Model 728251 Product Usage: Computed Tomograph... | There is a potential for separation of fiberglass resin which may cause the gantry front cover an... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 18, 2018 | Brilliance 64, Model 728231 Product Usage: Computed Tomography X-ray sys... | There is a potential for separation of fiberglass resin which may cause the gantry front cover an... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 18, 2018 | Brilliance 16 Slice (Power), Model 728240 Product Usage: Computed Tomogra... | There is a potential for separation of fiberglass resin which may cause the gantry front cover an... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 18, 2018 | Brilliance 40, Model 728235 Product Usage: Computed Tomography X-ray syst... | There is a potential for separation of fiberglass resin which may cause the gantry front cover an... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 18, 2018 | Brilliance 6 Slice (Air), Model 728256 Product Usage: Computed Tomography... | There is a potential for separation of fiberglass resin which may cause the gantry front cover an... | Class II | Philips Medical Systems (Cleveland) Inc |
| Oct 5, 2018 | AIA-900 Automated Immunoassay Analyzer, product code 022930 /022930R Produ... | Tosoh Bioscience has become aware of a potential issue with the axis base of the turntable rotati... | Class II | Tosoh Bioscience Inc |
| Oct 5, 2018 | AIA-900 Analyzer, Product code 022930, 022930R | Tosoh Bioscience has become aware of a potential issue with the pickup arm and pickup arm motor o... | Class II | Tosoh Bioscience Inc |
| Oct 5, 2018 | Hemoglobin A1c Control, Part no. 220232 for use as quality control material t... | Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the... | Class III | Tosoh Bioscience Inc |
| Sep 28, 2018 | Tosoh AIA-900 immunoassay Analyzer | A software issue may cause the liquid volume detection entries for 2nd and 3rd reagent bottles to... | Class II | Tosoh Bioscience Inc |
| Sep 28, 2018 | AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AI... | There is a possibility that the liquid suction pump on some AIA-2000 analyzers may not perform as... | Class II | Tosoh Bioscience Inc |
| Sep 28, 2018 | AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AI... | Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers th... | Class II | Tosoh Bioscience Inc |
| Sep 28, 2018 | AIA-2000 Analyzer, Product code 022100, 022100R, 022101, 022101R The AIA-... | Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers th... | Class II | Tosoh Bioscience Inc |
| Sep 4, 2018 | Hemotherm 400CE, Catalog Numbers 86022 & 86023 The Hemotherm¿ Dual Rese... | Potential for membrane (control panel) switch errors leading to an inability of the device to cha... | Class II | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Sep 4, 2018 | Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usa... | Software Correction: Software errors that may result in incorrect 4D CT images, PET images with S... | Class II | Philips Medical Systems (Cleveland) Inc |
| Aug 23, 2018 | AIA-360 Analyzer, product code 019945/019945R The Tosoh AIA-360 Automated... | The firm has implemented new product labeling changes for the Tosoh AIA-360 Analyzer. These label... | Class II | Tosoh Bioscience Inc |
| Aug 21, 2018 | ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catal... | ParaPost Plus Titanium Posts contain stainless steel post that are a size 4 | Class II | Coltene Whaledent Inc |
| Jul 26, 2018 | AMSCO V-PRO 1, V-PRO 1 Plus, and V-PRO maX Low Temperature Sterilization Syst... | There is the potential for a scenario where a punctured cup of sterilant expires while the system... | Class II | Steris Corporation |
| Jul 13, 2018 | G8 Automated HPLC Analyzer - 723G8 Product Usage - In vitro diagnostic use... | Analyzers were distributed with software which lacks a 510K | Class II | Tosoh Bioscience Inc |
| Jul 3, 2018 | Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems in... | Philips has identified that the compensator within the X-ray tube collimator may fail, resulting ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 3, 2018 | Brilliance iCT, 728306 Product Usage: Computed Tomography X-ray systems i... | Philips has identified that the compensator within the X-ray tube collimator may fail, resulting ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jul 3, 2018 | Brilliance 16 Air, 728246 Product Usage: Computed Tomography X-ray system... | Philips has identified that the compensator within the X-ray tube collimator may fail, resulting ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 29, 2018 | Hitachi Scenaria CT system Product Usage: The SCENARIA CT system is indic... | The firm received a complaint where, during patient positioning, the technologist was adjusting t... | Class II | Hitachi Medical Systems America Inc |
| Jun 29, 2018 | Dymaxeon 5.5 Curved Rod Size 5.5 x 110mm (Yellow), Model Number 06.6441B P... | Packages labeled as containing 110mm rods may contain 100mm rods. | Class II | Back 2 Basics Direct LLC |
| Jun 18, 2018 | CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L ... | A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement ... | Class I | Compass Health Brands (Corporate Office) |
| Jun 18, 2018 | Hitachi Oasis MRI system Product Usage: Hitachi MR system is an imaging d... | The stainless steel belt which runs the length of the table underneath the tabletop is exposed wh... | Class II | Hitachi Medical Systems America Inc |
| Jun 8, 2018 | Zimmer Dermatone AN, Model No. 88710100 | Devices may have a loose control bar, which could compromise the ability to control the thickness... | Class II | Zimmer Surgical Inc |
| Jun 6, 2018 | G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674 ... | HbAE is known to interfere with the HbA1c assay on the current version of software, Ver. 5.23. Cu... | Class II | Tosoh Bioscience Inc |
| Jun 5, 2018 | Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027... | Distribution of unapproved product labeling | Class III | Tosoh Bioscience Inc |
| May 23, 2018 | Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003... | The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical ... | Class II | Steris Corporation |
| May 21, 2018 | Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01... | The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw ... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 3, 2018 | HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length ... | The devices may have been assembled with an internal component that may cause continuous or inadv... | Class II | Ethicon Endo-Surgery Inc |
| May 3, 2018 | HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length ... | The devices may have been assembled with an internal component that may cause continuous or inadv... | Class II | Ethicon Endo-Surgery Inc |
| Apr 17, 2018 | Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004 | Improper installation of hand piece may result in a weakening of the internal hose connection whi... | Class II | Exsurco Medical |
| Apr 13, 2018 | Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model ... | The products are labeled with an incorrect product number. | Class II | Coltene Whaledent Inc |
| Apr 6, 2018 | EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: ... | The retail shelf cartons may be labeled with an incorrect lot number. | Class II | MHC Medical Products LLC |
| Apr 6, 2018 | EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: IN... | The retail shelf cartons may be labeled with an incorrect lot number. | Class II | MHC Medical Products LLC |
| Mar 30, 2018 | Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 7282... | The patient support head holder could contact the back ISO shelter wall during manual or motorize... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 30, 2018 | Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 72... | The patient support head holder could contact the back ISO shelter wall during manual or motorize... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 30, 2018 | Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 7282... | The patient support head holder could contact the back ISO shelter wall during manual or motorize... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 28, 2018 | Ingenuity Core128/Elite China 728324 | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 28, 2018 | Ingenuity TF PET/CT 882442 | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 28, 2018 | Ingenuity Core128 728323 | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 28, 2018 | Philips Ingenuity Core 728321 | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 28, 2018 | Brilliance Big Bore Radiology 728244 | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... | Class II | Ethicon Endo-Surgery Inc |
| Mar 26, 2018 | 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability S... | Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... | Class II | Ethicon Endo-Surgery 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.