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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 10, 2020 | AIA-360 Automated Immunoassay Analyzer, Product Code 019945 | A display screen software issue on the analyzer causes the display to freeze when display screen ... | Class II | Tosoh Bioscience Inc |
| Jan 3, 2020 | Zimmer Sterile Disposable Tourniquet Cuff with Protective Sleeve and PLC, D... | When inflating/deflating a single bladder, both bladders could potentially inflate/deflate due to... | Class II | Zimmer Surgical Inc |
| Dec 26, 2019 | Kangaroo Epump Safety Screw Spike Set, Anti-free Flow, Product Code 775659 | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Joey Safety Screw Spike Set, Anti-free Flow, Product Code 765559 | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Prod... | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Epump Safety Screw Spike with Flush Bag, Anti-free Flow, 1000 mL, Pr... | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo 924 Safety Screw Spike Set, Product Code 775759 | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 26, 2019 | Kangaroo Connect ENPlus Spike Set Anti-free Flow, Product Code 77000FD | The feeding spike sets may leak at the interface of the tube and spike connector. | Class II | Cardinal Health Inc. |
| Dec 11, 2019 | Giraffe Blue Spot PT LiteTM Phototherapy System, Model Numbers M1224917, M123... | There is a potential for some systems built between 2014 and Jan 2018 to have a light output fall... | Class II | Lumitex Inc |
| Nov 15, 2019 | AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of ca... | The AIA-2000 bar code scanners depend on the quiet zone to help identify the bar code. The lack o... | Class III | Tosoh Smd Inc |
| Nov 15, 2019 | PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intende... | A defect involving an occluded needle was discovered during a training exercise. | Class I | Tytek Medical Inc |
| Nov 14, 2019 | Cordis S.M.A.R.T. CONTROL /S.M.A.R.T. Vascular Stent System. The S.M.A.R.... | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... | Class II | Cardinal Health Inc. |
| Nov 14, 2019 | S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent Syst... | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... | Class II | Cardinal Health Inc. |
| Nov 14, 2019 | Cordis Precise Nitinol Stent System. The Cordis PRECISE Nitinol Stent Sys... | Cordis has initiated a labeling correction for S.M.A.R.T. and PRECISE stents due to incorrect MRI... | Class II | Cardinal Health Inc. |
| Nov 7, 2019 | Ligamax 5 mm Endoscopic Multiple Clip Applier | A potential exists that certain LIGAMAX devices within the impacted lots may have small holes in... | Class II | Ethicon Endo-Surgery Inc |
| Oct 22, 2019 | Eagle 3000 Sterilizer, small steam sterilizer. Product Usage: The Eagle 3000 ... | Potential for the incorrect pressure safety valve being included in the Preventive Maintenance (P... | Class II | Steris Corporation |
| Oct 22, 2019 | Evolution Loading Car and Transfer Carriage- Accessory to the Sterilizer, Steam | The locking pin of the front wheel asse mbly of the Evolution Transfer Carriages may not remain ... | Class II | Steris Corporation |
| Oct 16, 2019 | Hitachi Scenaria Whole-body X-ray CT System | There is a possibility that the cables to the controller unit may not be affixed properly, creati... | Class II | Hitachi Medical Systems America Inc |
| Oct 3, 2019 | ECHELON FLEX Powered Plus ENDOPATH 60mm Stapler - 440mm 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 Powered Plus ENDOPATH 60mm Stapler - 340mm 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 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 |
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.