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 5, 2018 ST-AIA PACK T4; Part Number: 025258 Assay, Thyroid Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK PA; Part Number: 025263 Assay, Tumor Marker Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 Tosoh ST AIA-PACK HbA1c Control, HbA1c Control, PN 025418 The product is i... The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient re... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK FSH; Part Number: 025265 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK IGE II; Part Number: 025295 Assay, Allergy Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK ¿HCG; Part Number: 025261 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Fer; Part Number: 025253 Assay, Anemia Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK CA 19-9; Part Number: 025271 Assay, Tumor Marker Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Prolactin; Part Number: 025255 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Cort; Part Number: 025287 Assay, Metabolic Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Testosterone; Part Number: 025204 Assay, Reproductive Hormone Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Feb 21, 2018 Brilliance 64 with 4.1.7 XX026 software version model number 728231 Produc... Surview scan with tube current lower than 30 mA is unable to be initialized. Class II Philips Medical Systems (Cleveland) Inc
Feb 15, 2018 Ingenuity TF PET/CT, Model No. 882442 Product Usage: The device is an int... Following a period of inactivity, the mass storage device may cause the acquisition console to be... Class II Philips Medical Systems (Cleveland) Inc
Feb 13, 2018 ST AIA-PACK¿ PROG II, Progesterone II Assay, Part Number: 025239 Falsely elevated progesterone assay values will occur when using certain progesterone assay part ... Class II Tosoh Bioscience Inc
Feb 13, 2018 ST AIA-PACK¿ PROG III, Progesterone III Assay, Part Number: 025240 Falsely elevated progesterone assay values will occur when using certain progesterone assay part ... Class II Tosoh Bioscience Inc
Feb 8, 2018 Brilliance Big Bore (Oncology) - Model no. 728243, 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
Feb 8, 2018 Brilliance iCT SP - Model no. 728311 Computed Tomography X-Ray system Prod... 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 6 Slice (Air) - Model no. 728256, 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 Brilliance iCT - Model no. 728306 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 IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Prod... 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 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

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.