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
Mar 26, 2018 5mm Endopath Xcel with Optiview Technology, Bladeless Trocar with Stability S... Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... Class II Ethicon Endo-Surgery Inc
Mar 26, 2018 5mm Endopath Xcel with Optiview Technology, Universal Trocar with Stability S... Use of the product with insufficient lubrication may prolong surgery due to trocar replacement. I... Class II Ethicon Endo-Surgery Inc
Mar 5, 2018 ST-AIA PACK IRI; Part Number: 025260 Assay, Diabetes Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 AIA-PACK TSH 3rd Generation; Part Number: 020294 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 SHBG; Part Number: 025238 Assay, Reproductive Hormone 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 Pretreatment Solution, HbA1c Pretreatment Solution, P... The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient re... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Myoglobin; Part Number: 025297 Assay, Cardiac 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 HCG; Part Number: 025256 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 C-Peptide II; Part Number: 025283 Assay, Diabetes Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK BMG; Part Number:025259 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 PAP; Part Number: 025262 Assay, Prostate Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK Estradiol; Part Number: 025274 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 cTnI 2nd Gen; Part Number: 025205 Assay, Cardiac 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 TT3; Part Number: 025282 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 FT3; Part Number: 025286 Assay, Thyroid 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 Calibrator, HbA1c Calibrator, PN 025318 The produc... The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient re... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK hsE2; Part Number: 025225 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 C-Peptide; Part Number: 025284 Assay, Diabetes Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely in... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK AFP; Part Number: 025252 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 HGH; Part Number: 025266 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 TU; Part Number: 025270 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 Cystatin C; Part Number: 025217 Assay, Kidney 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, HbA1c Reagent, Pt. No. 025218 The device is desig... The assay can potentially generate erroneously elevated or erroneously decreased HbA1c patient re... Class II Tosoh Bioscience Inc
Mar 5, 2018 ST-AIA PACK FT4; Part Number: 025268 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 DHEA-S; Part Number: 025222 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 LH II; Part Number: 025296 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 27.29; Part Number: 025202 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 CK-MB; Part Number: 025269 Assay, Cardiac 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 Prog II; Part Number: 025239 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 CEA; Part Number: 025254 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 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

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.