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.

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DateProductReasonClassFirm
Feb 8, 2018 Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system Product... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Ingenuity CT - Model no. 728326, 728325, Computed Tomography X-Ray system ... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Ingenuity Flex - Model no. 728317, Computed Tomography X-Ray system Produc... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Ingenuity Core 128 - Model no. 728323, 728324, Computed Tomography X-Ray syst... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Brilliance 16 Slice (Air) - Model no. 728246, Computed Tomography X-Ray syste... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Ingenuity Core - Model no. 728321, Computed Tomography X-Ray system Product ... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Feb 8, 2018 Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray... Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move durin... Class II Philips Medical Systems (Cleveland) Inc
Jan 11, 2018 IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Comput... 23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues inc... Class II Philips Medical Systems (Cleveland) Inc
Jan 3, 2018 Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244... Software issues including: Software errors that may result in Extended Field of View check messa... Class II Philips Medical Systems (Cleveland) Inc
Jan 3, 2018 Brilliance Big Bore Oncology CTwith 4.2.0 software version. Model #' 728243 ... Software issues including: Software errors that may result in Extended Field of View check messa... Class II Philips Medical Systems (Cleveland) Inc
Dec 15, 2017 Precedence 16 Model # 882350 Product Usage: Precedence (cleared as Griffi... During collimator exchange, the alignment of the collimator cart and detectors may cause a collim... Class II Philips Medical Systems (Cleveland) Inc
Dec 15, 2017 BrightView X, Model #882478 Product Usage: BrightView and BrightView X a... During collimator exchange, the alignment of the collimator cart and detectors may cause a collim... Class II Philips Medical Systems (Cleveland) Inc
Dec 15, 2017 BrightView XCT Model 882482 Product Usage: BrightView XCT is a gamma came... During collimator exchange, the alignment of the collimator cart and detectors may cause a collim... Class II Philips Medical Systems (Cleveland) Inc
Dec 15, 2017 Precedence 6 Model # 882351 Product Usage: Precedence (cleared as Griffin... During collimator exchange, the alignment of the collimator cart and detectors may cause a collim... Class II Philips Medical Systems (Cleveland) Inc
Dec 15, 2017 BrightView Model 882480 Product Usage: BrightView and BrightView X are g... During collimator exchange, the alignment of the collimator cart and detectors may cause a collim... Class II Philips Medical Systems (Cleveland) Inc
Dec 11, 2017 Ingenuity TF PET/CT (model 882442) running software version 4.0.2 This d... A software issue causes PET reconstructions to fail intermittently. It was determined that recons... Class II Philips Medical Systems (Cleveland) Inc
Dec 6, 2017 Refractor Suspension Arm (P/N: 525004, 05 and 525006, 07) The Intended ... Product has been found with a missing Washer, Retaining Ring, and/or Stop Screw. Recalling firm w... Class II Reliance Medical Products Inc
Nov 27, 2017 Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Produc... Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections relate... Class II Cincinnati Sub-Zero Products LLC
Nov 10, 2017 Brilliance 64, (Code 728231) Intended to produce images of the head and bo... Philips has identified that certain fasteners cannot be confirmed to have been torqued according ... Class II Philips Medical Systems (Cleveland) Inc
Nov 10, 2017 Ingenuity Core, (Code 728321) Intended to produce images of the head and b... Philips has identified that certain fasteners cannot be confirmed to have been torqued according ... Class II Philips Medical Systems (Cleveland) Inc
Nov 10, 2017 Brilliance iCT Intended to produce images of the head and body by computer... Philips has identified that certain fasteners cannot be confirmed to have been torqued according ... Class II Philips Medical Systems (Cleveland) Inc
Nov 10, 2017 Ingenuity Core 128, (Code 728323) Intended to produce images of the head a... Philips has identified that certain fasteners cannot be confirmed to have been torqued according ... Class II Philips Medical Systems (Cleveland) Inc
Nov 8, 2017 Philips Healthcare IQon Spectral CT computed tomography x-ray system There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to t... Class II Philips Medical Systems (Cleveland) Inc
Nov 8, 2017 Philips Healthcare Brilliance iCT SP computed tomography x-ray system There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to t... Class II Philips Medical Systems (Cleveland) Inc
Nov 8, 2017 Philips Healthcare Brilliance iCT computed tomography x-ray system There is a possibility that screws holding an internal portion of the gantry (Reaction Ring) to t... Class II Philips Medical Systems (Cleveland) Inc
Nov 1, 2017 Ingenuity TF PET/CT - a integrated diagnostic X-ray Computed Tomography (CT) ... One of the two wire channels mounted inside the Gantry Separation Unit (GSU) that is also used to... Class II Philips Medical Systems (Cleveland) Inc
Oct 23, 2017 Disposable Curved Circular Staplers Product Usage: Staplers have applicat... There is a potential for the devices to create staples that do not meet formed staple height spec... Class II Ethicon Endo-Surgery Inc
Oct 20, 2017 Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with ... The ultrasound probe may not have adequate protection against electrical shock hazards. Class II Hitachi Medical Systems America Inc
Oct 6, 2017 Philips Ingenuity Core 128 computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class II Philips Medical Systems (Cleveland) Inc
Oct 6, 2017 Philips Ingenuity CT computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class II Philips Medical Systems (Cleveland) Inc
Oct 6, 2017 Philips Ingenuity Core computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class II Philips Medical Systems (Cleveland) Inc
Oct 6, 2017 Philips Brilliance 64 computed tomography x-ray system Numerous issues related to software Brilliance iCT 4.1.6 software version. Class II Philips Medical Systems (Cleveland) Inc
Sep 28, 2017 AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay... The firm has become aware of a potential issue that may affect the mixing motor drive harness and... Class II Tosoh Bioscience Inc
Sep 28, 2017 V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000) Correction to update sterilizer software to prohibit the use of expired sterilant prior to the st... Class II Steris Corporation
Jul 27, 2017 A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be u... Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3... Class II Zimmer Surgical Inc
Jul 27, 2017 A.T.S. 2200TS Tourniquet Systems, Personalized Pressure. Zimmer Surgical, In... Updated on-device label and 3 pages of an updated Operator/Service Manual. Also, decrease from 3... Class II Zimmer Surgical Inc
Jul 11, 2017 Brilliance iCT SP - Model 728311 Brilliance iCT - Model 728306 Computed Tom... Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, da... Class II Philips Medical Systems (Cleveland) Inc
Jul 11, 2017 Brilliance iCT - Model 728306 Computed Tomography X-ray systems Numerous software issues with Brilliance iCT 4.1.6 version. Issues affect scan start position, da... Class II Philips Medical Systems (Cleveland) Inc
Jun 15, 2017 Vis-U-All High Temperature Tubing 14"x100'. One roll per box; 10 boxes per ca... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box; 4 boxes per... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temperature Tubing 4"x100'. One roll per box; 10 boxes per cas... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box; 4 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box; 4 boxes pe... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temperature Tubing 6"x100'. One roll per box; 10 boxes per cas... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temperature Tubing 9"x100'. One roll per box; 10 boxes per cas... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 5"x15" Heat Seal Pouch 200 pouches per box; 4 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 5"x15" Self Seal Pouch 200 pouches per box; 4 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 16"x16" Self Seal Pouch 100 pouches per box; 6 boxes per ... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 8"x16" Heat Seal Pouch 100 pouches per box; 9 boxes per c... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris Corporation
Jun 15, 2017 Vis-U-All High Temp 3"x8" Heat Seal Pouch 200 pouches per box; 5 boxes per ca... On June 15, 2017, STERIS identified that the purple ink located on the outside label of Vis-U-All... Class II Steris 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.