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 29, 2016 | Brilliance iCT SP Model No. 728311; To produce cross-sectional images of the ... | Software issues found in v4.1 .3/4.1.5 in the Philips Brilliance iCT/ iCT SP products that could... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 29, 2016 | Brilliance 64 CT Model 728231; To produce cross-sectional images of the body. | Software issues found in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 produ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 20, 2016 | MX 16-slice whole body computed tomography X-ray system. Imaging diagnostic t... | The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 20, 2016 | MX 16-slice SKD whole body computed tomography X-ray system. Imaging diagnos... | The following issues have been found in MX 16-slice systems with software version 1.1.4.21426: ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 14, 2016 | CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules, w... | During a recent Ohio site inspection by the FDA it was discovered that warning statements needed ... | Class III | Affymetrix Inc |
| Apr 8, 2016 | Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to pr... | The firm became aware of a problem where the system may not map Varian drive after CT user logout... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 8, 2016 | Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended t... | The firm became aware of a problem where the system may not map Varian drive after CT user logout... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 8, 2016 | Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Inten... | The firm became aware of a problem where the system may not map Varian drive after CT user logout... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 8, 2016 | Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Inten... | The firm became aware of a problem where the system may not map Varian drive after CT user logout... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 1, 2016 | Ingenuity Core-Computed Tomography X-ray system Product Usage: The Ingenu... | Philips Healthcare received reports from the field that certain Ingenuity Core systems running so... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 1, 2016 | Ingenuity Core 128-Computed Tomography X-ray system Product Usage: The In... | Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running... | Class II | Philips Medical Systems (Cleveland) Inc |
| Apr 1, 2016 | Brilliance 64, Computed Tomography X-ray system Product Usage: The Brilli... | Philips Healthcare received reports from the field that certain Brilliance 64 systems running sof... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Ingenuity Core Computed Tomography X-ray systems is intended to produce cross... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produ... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to p... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce c... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to pr... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 24, 2016 | Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-... | Software defect causing intermittently slow response of Host. | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 15, 2016 | Junction Boxes, Product Usage: The Invacare Bariatric home care bed is i... | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric... | Class II | Invacare Corporation |
| Mar 15, 2016 | Invacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usa... | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric... | Class II | Invacare Corporation |
| Mar 15, 2016 | Invacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product... | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric... | Class II | Invacare Corporation |
| Mar 15, 2016 | Invacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Pro... | The firm recently identified a quality issue with the Junction box used in the Invacare Bariatric... | Class II | Invacare Corporation |
| Mar 10, 2016 | Poly-bags containing the strap labeled with "Adult" sticker. Each strap ki... | On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the o... | Class II | Ferno-Washington Inc |
| Mar 10, 2016 | Poly-bags containing splint strap labeled with "Pediatric" sticker. Each s... | On March 9, 2016, the firm was contacted regarding the possibility of incorrect labeling on the o... | Class II | Ferno-Washington Inc |
| Mar 7, 2016 | MRIdian ViewRay Radiation Therapy System, ViewRay Treatment Planning and Deli... | When editing the isocenter or the couch position of the plan while in the treatment workflow (in ... | Class II | Viewray Incorporated |
| Mar 4, 2016 | Extended Brilliance Workspace NM Nuclear medicine image display and processin... | The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with d... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 4, 2016 | Extended Brilliance Workspace NM Special Nuclear medicine image display and p... | The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with d... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 4, 2016 | IntelliSpace Portal DX/HX/EX AutoSPECT Pro Software Application, Philips Medi... | The AutoSPECT Pro application was only designed to reconstruct cardiac SPECT data obtained with d... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 25, 2016 | TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high... | The firm received a complaint of the battery exploding while recharging. | Class II | Scottcare Corporation |
| Feb 17, 2016 | TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STA... | The firm received a complaint of an open pouch which breaches the sterilization validation. | Class II | Applied Medical Technology Inc |
| Feb 17, 2016 | Wilson Implantation System Product Usage: Indicated to aid in tissue retr... | The firm received a complaint of an open pouch which breaches the sterilization validation. | Class II | Applied Medical Technology Inc |
| Feb 17, 2016 | TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO... | The firm received a complaint of an open pouch which breaches the sterilization validation. | Class II | Applied Medical Technology Inc |
| Feb 17, 2016 | Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile E... | The firm received a complaint of an open pouch which breaches the sterilization validation. | Class II | Applied Medical Technology Inc |
| Feb 5, 2016 | Brilliance iCT Computed Tomography X-ray Systems, Intended to produce cross-... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2016 | Ingenuity Core Computed Tomography X-ray Systems, Intended to produce cros... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2016 | Ingenuity Core 128 Computed Tomography X-ray Systems, Intended to produce cr... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2016 | Brilliance 64:Computed Tomography X-ray Systems, Intended to produce cross-s... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2016 | Ingenuity CT Computed Tomography X-ray Systems, Intended to produce cross-se... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2016 | Brilliance iCT SP Computed Tomography X-ray Systems, Intended to produce cro... | The firm was notified of a software error in which the system may not automatically send all imag... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 2, 2016 | Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for ... | The firm discovered that the incorrect lot number was engraved on the product. | Class III | Volk Optical Inc |
| Jan 26, 2016 | AMT G-Jet¿ Low-Profile Transgastric-Jejunal Feeding Device 14F 1.5cm 45cm SIN... | The firm received complaints that the product is shorter in length than indicated on the label. | Class II | Applied Medical Technology Inc |
| Dec 24, 2015 | MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc. | The system loaded a completion fraction in the incorrect order after a treatment interruption. | Class II | Viewray Incorporated |
| Dec 17, 2015 | BrightView X are gamma cameras; Designed for single or dual detector nuclear ... | The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardia... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 17, 2015 | BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emi... | The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardia... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 17, 2015 | BrightView are gamma cameras; Designed for single or dual detector nuclear im... | The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardia... | Class II | Philips Medical Systems (Cleveland) Inc |
| Dec 4, 2015 | Quick Connects. Steris Corporation. Model numbers: QKC1736E, QKC1736INT, QKC... | The firm discovered that one of the hysteroscope models listed for processing in four existing Qu... | Class II | Steris Corporation |
| Nov 25, 2015 | TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STA... | The firm was notified by some of their customers that some of the sealed pouches contain tears co... | Class II | Abeon Medical Corporation |
| Nov 25, 2015 | TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) Indica... | The firm was notified by some of their customers that some of the sealed pouches contain tears co... | Class II | Abeon Medical Corporation |
| Nov 25, 2015 | Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile E... | The firm was notified by some of their customers that some of the sealed pouches contain tears co... | Class II | Abeon Medical 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.