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
Jun 5, 2018 Tosoh Bioscience AIA Analyte Application Manual (AAM) CD Part Number: 997027... Distribution of unapproved product labeling Class III Tosoh Bioscience Inc
May 23, 2018 Reliance 1227 Cart and Utensil Washer/Disinfector, FW03101, FW03102, FW03S003... The firm has become aware that the Reliance 1227 Cart and Utensil Washer/Disinfector s Chemical ... Class II Steris Corporation
May 21, 2018 Ingenuity Digital PET/CT System, Model 882446 with the following UDI's: (01... The block used to connect the patient pallet to the couch may be assembled incorrectly. A screw ... Class II Philips Medical Systems (Cleveland) Inc
May 3, 2018 HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length ... The devices may have been assembled with an internal component that may cause continuous or inadv... Class II Ethicon Endo-Surgery Inc
May 3, 2018 HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length ... The devices may have been assembled with an internal component that may cause continuous or inadv... Class II Ethicon Endo-Surgery Inc
Apr 17, 2018 Amalgatome SD, COAXIAL PNEUMATIC HOSE, SCHRADER, Model X101004 Improper installation of hand piece may result in a weakening of the internal hose connection whi... Class II Exsurco Medical
Apr 13, 2018 Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model ... The products are labeled with an incorrect product number. Class II Coltene Whaledent Inc
Apr 6, 2018 EasyTouch (ET) Insulin Syringe 29G 0.5ml ¿" (Item 829555) Product Usage: ... The retail shelf cartons may be labeled with an incorrect lot number. Class II MHC Medical Products LLC
Apr 6, 2018 EasyTouch (ET) Insulin Syringe 29G 1ml ¿" (Item 829155) Product Usage: IN... The retail shelf cartons may be labeled with an incorrect lot number. Class II MHC Medical Products LLC
Mar 30, 2018 Brilliance 64 with DEPMED HARDENING KIT 12NC: 459800191351, Model Number 7282... The patient support head holder could contact the back ISO shelter wall during manual or motorize... Class II Philips Medical Systems (Cleveland) Inc
Mar 30, 2018 Brilliance 16 P with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 72... The patient support head holder could contact the back ISO shelter wall during manual or motorize... Class II Philips Medical Systems (Cleveland) Inc
Mar 30, 2018 Brilliance 16 with DEPMED HARDENING KIT 12NC: 453567400741, Model Number 7282... The patient support head holder could contact the back ISO shelter wall during manual or motorize... Class II Philips Medical Systems (Cleveland) Inc
Mar 28, 2018 Ingenuity Core128/Elite China 728324 A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... Class II Philips Medical Systems (Cleveland) Inc
Mar 28, 2018 Ingenuity TF PET/CT 882442 A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... Class II Philips Medical Systems (Cleveland) Inc
Mar 28, 2018 Ingenuity Core128 728323 A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... Class II Philips Medical Systems (Cleveland) Inc
Mar 28, 2018 Philips Ingenuity Core 728321 A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... Class II Philips Medical Systems (Cleveland) Inc
Mar 28, 2018 Brilliance Big Bore Radiology 728244 A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that a... Class II Philips Medical Systems (Cleveland) Inc
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 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, 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

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.