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 6, 2015 | Diamond Select Brilliance CT 16 (Uninterruptible Power Supply (UPS) accessory... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | GEMINI TF PET/CT 16 Slice (Uninterruptible Power Supply (UPS) accessory devic... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT 40 - Slices (Uninterruptible Power Supply (UPS) accessory devic... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Forte-JetStream AZ (Uninterruptible Power Supply (UPS) accessory devices) Com... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | iCT SP (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogr... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT 64 channel with Essence, Technology (Uninterruptible Power Supp... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity Core 128 (Uninterruptible Power Supply (UPS) accessory devices) Com... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | GEMINI TF Ready (Uninterruptible Power Supply (UPS) accessory devices) Comput... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | BrightView XCT (Uninterruptible Power Supply (UPS) accessory devices) Compute... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT Big Bore Radiology (Uninterruptible Power Supply (UPS) accessor... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | AXIS (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomograp... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT 40 - Slices(Uninterruptible Power Supply (UPS) accessory device... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Gemini 16 PET/CT System (Uninterruptible Power Supply (UPS) accessory device... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Precedence 16 (Uninterruptible Power Supply (UPS) accessory devices) Computed... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity CT (Uninterruptible Power Supply (UPS) accessory devices) Computed ... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | BrightView SPECT (Uninterruptible Power Supply (UPS) accessory devices) Compu... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | TruFlight Select PET/CT 16-slice (Uninterruptible Power Supply (UPS) accesso... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | FORTE (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomogra... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) C... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance iCT (Uninterruptible Power Supply (UPS) accessory devices) Compute... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity Core (Uninterruptible Power Supply (UPS) accessory devices) Compute... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Compute... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Brilliance CT 6 Slice Air (Uninterruptible Power Supply (UPS) accessory devic... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Ingenuity PET/MR (Uninterruptible Power Supply (UPS) accessory devices) Comp... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | GEMINI TF Big Bore (Uninterruptible Power Supply (UPS) accessory devices) Com... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | Gemini LXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) C... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | GEMINI TF PET/CT 64 Slice (Uninterruptible Power Supply (UPS) accessory devic... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | MX 16 Slice Phase II (Uninterruptible Power Supply (UPS) accessory devices) C... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Mar 6, 2015 | MX 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed T... | The firm was notified that the failure of the UPS accessory devices used in conjunction with Comp... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 27, 2015 | Lombart 90D Clear with case Visualization during diagnosis and laser therapy... | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct l... | Class III | Volk Optical Inc |
| Feb 27, 2015 | Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL IN... | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. | Class III | Volk Optical Inc |
| Feb 26, 2015 | ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Produ... | During an internal inspection of the production process the firm discovered an issue which may ca... | Class II | Ethicon Endo-Surgery Inc |
| Feb 19, 2015 | Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove ... | Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electri... | Class II | Steris Corporation |
| Feb 19, 2015 | AMSCO C and AMSCO 400 Steam Sterilizers, STERIS Corporation. AMSCO C Small... | STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will ... | Class II | Steris Corporation |
| Feb 17, 2015 | Velocity" Biopsy Valve, 25 units per box, Product Usage: The disposable ... | The company has received reports of structural non conformance at the connection between the valv... | Class II | US Endoscopy Group Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce ... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce c... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technol... | Philips discovered that a software defect exists in marketed product wherein the sign indication ... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems Ingenuity Core. Intended to produce cros... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produ... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray systems Brilliance iCT, Philips Healthcare System. ... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 5, 2015 | Computed Tomography X-ray Systems Brilliance CT 64-channel with Essence techn... | 5 issues. Fast Get Ready incorrectly enabled during service procedures. Contrast annotation miss... | Class II | Philips Medical Systems (Cleveland) Inc |
| Feb 2, 2015 | Invacare¿ Pronto¿ Air Personal Transporter (power wheelchair), Invacare Corp... | The batteries used in the Invacare¿ Pronto¿ Air Personal Transporter models power wheelchairs hav... | Class II | Invacare Corporation |
| Jan 31, 2015 | Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure ... | The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed ... | Class I | Western / Scott Fetzer Company |
| Jan 15, 2015 | Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (... | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the ... | Class II | Invacare Corporation |
| Jan 15, 2015 | FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power... | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the ... | Class II | Invacare Corporation |
| Jan 15, 2015 | TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power... | If the slack in the wires is not routed and secured correctly, flexing of the back pan under the ... | Class II | Invacare Corporation |
| Jan 15, 2015 | ViewRay System, Radiation Therapy System | The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) ... | Class II | Viewray Incorporated |
| Jan 9, 2015 | Echostar Spica 1.5T MRI system, for magnetic resonance imaging of the body. | The MRI system safety feature, which lowers the magnetic field in emergency situations, may not w... | Class I | Alltech Medical Systems America 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.