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
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.