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 |
|---|---|---|---|---|
| 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 |
| 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 |
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.