Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 7, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Philips Network Firewall (Cisco ASA 5506) Firewall installed with Philips IntelliVue Information Center iX or Information Center Classic may have a defective component, which may result in loss of… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, CRESCENT BLADE STRAIGHT BEVEL UP STR The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, CRESCENT BLADE BEVELED UP ANGLED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, CRESCENT BLADE ANGLED TIP BEVEL UP The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, CRESCENT BLADE BEVELED DN The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, CRESCENT KNIFE BEVELED UP ANGLED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 15 DEGREE STAB BLADE The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 15 DEGREE STAB BLADE TIP The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 19 GAUGE MVR BLADE The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 20 GAUGE MVR BLADE The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 22.5 DEGREE STAB BLADE The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75 The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.85 The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.855MM GUARDED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, CLEAR 3.0 MM CLEAR CORNEAL ANGLED KNIFE The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 30 DEGREE STAB BLADE The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 30 DEGREE STAB BLADE TIP The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 2.2 MM SLIT KNIFE ANGLED DOUBLE BEVEL The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 2.4 MM SLIT KNIFE ANGLED DOUBLE BEVEL, REF/PRODUCT CODE E7549ADB, STERILE The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 2.5 MM SLIT KNIFE ANGLED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 2.6 MM SLIT KNIFE ANGLED DOUBLE BEVEL The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 2.5 MM SLIT KNIFE BEVEL UP ANGLED GUARDED(6/BOX), REF/PRODUCT CODE E7550AG, STERILE The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 2.65 MM SLIT KNIFE ANGLED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED DOUBLE BEVEL GUARDED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 2.65MM SLIT KNIFE ANGLED BEVEL UP GUARDED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 2.8MM SLIT KNIFE ANGLED DOUBLE BEVEL The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 2.85MM SLIT KNIFE ANGLED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED DOUBLE BEVEL The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 3.0MM SLIT KNIFE ANGLED GUARDED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 3.2MM STRAIGHT SLIT KNIFE The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 3.2MM SLIT KNIFE ANGLED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, KNIFE ANGLED BEVELED UP 2.7(6/BOX), REF/PRODUCT CODE E7559A, STERILE The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 4.0MM IMPLANT BLADE ANGLED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 5.2MM IMPLANT BLADE ANGLED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.75PAR The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, CLEAR CORNEAL ANGLED 2.9MM The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 1.1MM ARROW KNIFE ANGLED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 0.88MM ARROW KNIFE ANGLED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 1.6MM X 1.8MM TRAPEZOID ANGLED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 2.0MMX2.2MM TRAPEZOID ANGLED GUARDED The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 1.8mm x 2.2mm TRAPEZOID ANGLED KNIFE The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LASEREDGE Knives, 2.75MM THIN SLIT ANGLED BEVELED UP The complaints database was reviewed and there have been an atypical volume of dull blades complaints for various lots. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hemosll ReadiPlasTin Instrumentation Laboratory Co. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic Synchromed II Medtronic implemented a final design change intended to address the motor stall due to corrosion and is recalling devices with the previous design that are not… Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMar 14, 2018ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Auriga 30 Laser System, Universal Certain Auriga consoles have incorrectly assembled trigger wire components. Class IIFDA’s classMar 14, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 14, 2018ClassClass IIStatusTerminatedWhereNo state named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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