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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 3, 2019 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 280mm shaft, Product Code P... | The staplers may contain an out of specification anvil component within the jaw of the device. T... | Class I | Ethicon Endo-Surgery Inc |
| Oct 3, 2019 | ECHELON FLEX ENDOPATH 60mm Stapler - 340mm shaft, Product Code EC60A | The staplers may contain an out of specification anvil component within the jaw of the device. T... | Class I | Ethicon Endo-Surgery Inc |
| Sep 19, 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomi... | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... | Class I | Philips Medical Systems (Cleveland) Inc |
| Sep 19, 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomi... | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... | Class I | Philips Medical Systems (Cleveland) Inc |
| Sep 19, 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomi... | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... | Class I | Philips Medical Systems (Cleveland) Inc |
| Sep 19, 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomi... | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... | Class I | Philips Medical Systems (Cleveland) Inc |
| Sep 19, 2019 | Forte Gamma Camera System is intended to produce images depicting the anatomi... | An issue with the Detector for the Forte Family of cameras may result in either detector 1 or det... | Class I | Philips Medical Systems (Cleveland) Inc |
| Aug 20, 2019 | TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828 | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie... | Class II | Quality Electrodynamics LLC |
| Aug 20, 2019 | TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524 | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie... | Class II | Quality Electrodynamics LLC |
| Aug 20, 2019 | TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453 | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie... | Class II | Quality Electrodynamics LLC |
| Aug 20, 2019 | TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460 | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie... | Class II | Quality Electrodynamics LLC |
| Aug 20, 2019 | TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525 | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie... | Class II | Quality Electrodynamics LLC |
| Aug 20, 2019 | TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464 | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie... | Class II | Quality Electrodynamics LLC |
| Aug 20, 2019 | TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829 | Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Sie... | Class II | Quality Electrodynamics LLC |
| Aug 15, 2019 | Grab n Go Opti series VIPR system Model # PRX-9615 - Product Usage: The Gra... | Limited access to flow settings as a result of the control knob having been rotated beyond its f... | Class II | Western / Scott Fetzer Company |
| Aug 15, 2019 | Grab n Go Opti series VIPR system Model # PRX-9627 - Product Usage: The Gra... | Limited access to flow settings as a result of the control knob having been rotated beyond its f... | Class II | Western / Scott Fetzer Company |
| Aug 15, 2019 | Grab n Go Opti series VIPR system Model # PRX-9632 - Product Usage: The Gra... | Limited access to flow settings as a result of the control knob having been rotated beyond its f... | Class II | Western / Scott Fetzer Company |
| Aug 15, 2019 | Grab n Go Opti series VIPR system Model # PRX-9653 - Product Usage: The Gra... | Limited access to flow settings as a result of the control knob having been rotated beyond its f... | Class II | Western / Scott Fetzer Company |
| Aug 15, 2019 | Grab n Go Opti series VIPR system Model # PRX-9646 - Product Usage: The Gra... | Limited access to flow settings as a result of the control knob having been rotated beyond its f... | Class II | Western / Scott Fetzer Company |
| Jul 31, 2019 | HS Hi-R NEO 900A Reference # 657 821 Serial # from 101 Product Usage: A... | software error in the central control unit of the floor stand. | Class II | Haag-Streit USA Inc |
| Jul 31, 2019 | HS Hi-R NEO 900 Reference # 657 820 Serial # from 101 Product Usage: A... | software error in the central control unit of the floor stand. | Class II | Haag-Streit USA Inc |
| Jul 31, 2019 | HS Hi-R NEO 900A NIR Reference # 657 822 Serial # from 101 Product Usage... | software error in the central control unit of the floor stand. | Class II | Haag-Streit USA Inc |
| Jul 19, 2019 | MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to... | Updated Manual-Warnigs have been added stating that exceeding 40'C for extended periods may cause... | Class III | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jul 19, 2019 | ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagn... | Residual crystallization of the microplate and recurrent negative controls out of range. | Class II | Aniara Diagnostica LLC |
| Jul 19, 2019 | ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnos... | Residual crystallization of the microplate and recurrent negative controls out of range. | Class II | Aniara Diagnostica LLC |
| Jul 3, 2019 | PediaLift Access Device, Device Identifier: B751PDLFT0 | The firm was unsuccessful in obtaining a satisfactory Certificate of Conformance from the origi... | Class II | PediaLift LLC |
| Jul 2, 2019 | Blanketrol II Hyper-Hypothermia System, Models 222R and 222S - Product Usage... | Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue ... | Class II | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jul 2, 2019 | Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature ... | Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue ... | Class II | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jul 2, 2019 | CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool ... | Warnings statements have been added- exceeding 40 degree C for extended periods may cause tissue ... | Class II | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jun 24, 2019 | IQon Spectral CT Model # 728332, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Vereos PET/CT Model # 882446, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Ingenuity Core Model # 728321, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | iCT SP Model # 728311, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Ingenuity TF PET/CT Model # 882456, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Ingenuity CT, Model # 728326, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | iCT, Model # 728306, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Brilliance 64 Model # 728231, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 24, 2019 | Ingenuity Core128 Model # 728323, computed tomography x-ray system | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance se... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 20, 2019 | Norm-O-Temp model 111W | The manual does not provide instruction stating that exceeding 40 Celsius for extended periods ca... | Class II | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jun 20, 2019 | Norm-O-Temp model 111Z | The manual does not provide instruction stating that exceeding 40 Celsius for extended periods ca... | Class II | Cincinnati Sub-Zero Products LLC, a Gentherm Co... |
| Jun 10, 2019 | VAMPIRO V5001-minimally invasive poole suction sleeve that is an accessory in... | Lack of package integrity may compromise sterility | Class II | Santanello Surgical LLC |
| Jun 10, 2019 | BrightView X , Model Number 882478 | An issue with the handcontroller may result in either spontaneous uncommanded motions or continue... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 10, 2019 | BrightView SPECT, Model Number 882480 | An issue with the handcontroller may result in either spontaneous uncommanded motions or continue... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 10, 2019 | BrightView XCT , Model Number 882482 | An issue with the handcontroller may result in either spontaneous uncommanded motions or continue... | Class II | Philips Medical Systems (Cleveland) Inc |
| Jun 3, 2019 | Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomograp... | The Vereos PET/CT may have misaligned front and rear covers, which may result in gaps between cov... | Class II | Philips Medical Systems (Cleveland) Inc |
| May 29, 2019 | EPi-Sense Guided Coagulation System with Visitrax, MOdel No. CDK-1413 - Produ... | The sterile package seal for the Epi-Sense Guided Coagulation System may be compromised, and has ... | Class II | AtriCure, Inc. |
| May 15, 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C | Observed reported incidence rate for harm associated with intraoperative bleeding | Class II | Ethicon Endo-Surgery Inc |
| May 15, 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C | Observed reported incidence rate for harm associated with intraoperative bleeding | Class II | Ethicon Endo-Surgery Inc |
| May 15, 2019 | Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C | Observed reported incidence rate for harm associated with intraoperative bleeding | Class II | Ethicon Endo-Surgery Inc |
| Apr 16, 2019 | Zimmer Biomet Alvarado Knee Holder Base Plate Assembly and Foot Piece, & Alva... | Foreign Material in the Alvarado Knee Holder Base Plate Assembly and Foot Piece and Alvarado II B... | Class II | Zimmer Surgical 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.