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.

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DateProductReasonClassFirm
Mar 16, 2015 MX8000 Dualv. EXP, 728130. Computed Tomography X-ray systems intended to p... 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
Mar 16, 2015 Ingenuity CT. Computed Tomography X-ray systems intended to produce cross-... 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
Mar 16, 2015 Brilliance CT Big Bore Oncology. Computed Tomography X-ray systems intende... 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
Mar 16, 2015 Brilliance CT 64. 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
Mar 16, 2015 Brilliance CT 6 Air. Computed Tomography X-ray systems intended to produce... 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
Mar 16, 2015 Brilliance CT 16 Air. Computed Tomography X-ray systems intended to produc... 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
Mar 16, 2015 Brilliance CT 10 Air. Computed Tomography X-ray systems intended to produc... 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
Mar 16, 2015 Brilliance CT 16 Power. Computed Tomography X-ray systems intended to prod... 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
Mar 16, 2015 Brilliance iCT. Computed Tomography X-ray systems intended to produce cros... 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
Mar 16, 2015 Brilliance CT 16 Water. Computed Tomography X-ray systems intended to prod... 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
Mar 13, 2015 Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, AD... During clinical use of a Vertex Plus Gamma Camera, as the detector heads were in the relative 180... Class II Philips Medical Systems (Cleveland) Inc
Mar 11, 2015 Ingenuity TF Positron Emission Tomography (PET) and Magnetic Resonance Imagin... It was noticed that the spectroscopy voxel map did not align with the anatomical images of the ph... Class II Philips Medical Systems (Cleveland) Inc
Mar 11, 2015 Xpress System Pedicle Screw Assembly, 5.5 x 55mm. An internal fixation devi... One lot of instruments have etched on the Yoke of the Pedicle Screw a laser marking size of 7.5 x... Class II X Spine Systems Inc
Mar 11, 2015 Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC ... The firm was notified by a customer that the collimator exchange carriage and the collimator stor... Class II Philips Medical Systems (Cleveland) Inc
Mar 10, 2015 Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign b... A wire component on the distal grasping assembly of the device became detached.. Class II US Endoscopy Group Inc
Mar 6, 2015 Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devi... 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 6 (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 TF (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 X (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 CardioMD III (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 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

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.