Medical devices, 2019
Shortlist up to four to read them side by side.
2,801 medical device recalls FDA’s Enforcement Report published in 2019, 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 6, 2026.
2,801of 2,801 medical device recallsshown with your filters
The list
- Medical device recall ELLIPSE DR, Tiered-therapy cardioverter/defibrillator Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2019ClassClass IStatusTerminatedWhereNationwide
- Medical device recall ClubMax Laser Projection Series The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA’s Manual Reset Mechanism requirement for laser… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2019ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Atom Laser Projection Series The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA’s Manual Reset Mechanism requirement for laser… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2019ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Spectrum Laser Projection Series The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA’s Manual Reset Mechanism requirement for laser… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2019ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Maxim Laser Projection Series The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA’s Manual Reset Mechanism requirement for laser… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2019ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Logolas Laser Projection Series The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA’s Manual Reset Mechanism requirement for laser… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2019ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Burstberry Laser Projection Series The User Remote Interlock Dongle provided with the E-Stop Remote is not sufficient to fully comply with the FDA’s Manual Reset Mechanism requirement for laser… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 14, 2019ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Lidar System for Erosion Flume Application Class 1 Laser Product Product Usage: Product is installed and… Failure to comply event due to incorrect labeling of a class 1 laser product. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2019ClassClass IIStatusOngoingWhereNationwide
- Medical device recall YXLON Cheetah cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing… Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a door interlock that causes physical disconnection… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall YXLON Cougar Cabinet X-Ray System Product Usage: The products are generally used for non-destructive testing… Failure to meet the requirement of the performance standard for cabinet x-ray systems (21 CFR 1020.40) for a door interlock that causes physical disconnection… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and California and Illinois named
- Medical device recall MED EL Cochlear Implant System, SONATATIi100 Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and California and Illinois named
- Medical device recall MED EL Cochlear Implant System, PULSARci100 Standard - Product Usage: The PULSARci100 Implant is an… Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and California and Illinois named
- Medical device recall Toothete Oral Care Sodium Bicarbonate Mouthpaste A voluntary recall of a lot (67924) of Independent Care System due to the potential for damaged Sodium Bicarbonate Mouthpaste (cosmetic) tubes. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Georgia and Indiana named
- Medical device recall CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CERTAIN(R) BELLATEK(R) TIN ABUTMENT 3.4MM During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall CERTAIN(R) BELLATEK(R) TITANIUM ABUTMENT 3.4MM During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Olympus MAJ-209 Single Use Suction Valves There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Human Assayed Multi-Sera Level 2 The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis… Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive… There is an increased chance (approx. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall SenTec Standard Starter Set with and without Service Gas There is an increased chance (approx. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall SenTec Neonatal Starter Set with and without Service Gas There is an increased chance (approx. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall SenTec Membrane Changer Set There is an increased chance (approx. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall SenTec Membrane Changer Insert [5 pcs - Product Usage: is indicated for continuous, non-invasive monitoring… There is an increased chance (approx. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Missouri named
- Medical device recall PTS Panels Lipid Panel test strip: IVD Lipid Panel Test Strips The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 Class IIIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Henry Schein Panels Lipid Panel test strip: IVD Lipid Panel Test Strips The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 Class IIIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and California and Michigan named
- Medical device recall Serrato 9.5mm X 90mm Polyaxial Screw Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured… Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Massachusetts, New York, Pennsylvania and Texas named
- Medical device recall STERILE GRAVES VAGINAL SPECULUM MEDIUM Kit Code # GVS10MST - Product Usage:The speculum is used to spread the… Potential for sterile packaging to be compromised Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall STERILE FLUORO SSP TRAY Kit Code: MNS11605 - Product Usage: This kit is used for arthrogram injection and… Potential for sterile packaging to be compromised Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall CIRCUMCISION TRAY Kit Code: CIT2245 - Product Usage: Kit is used for performing circumcision procedures on… Potential for sterile packaging to be compromised Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on… Potential for sterile packaging to be compromised Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall NEONATAL PICC INSERTION TRAY Kit Code: CVI2310 - Product Usage: Kit is used for Peripheral Central Line… Potential for sterile packaging to be compromised Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist… Potential for sterile packaging to be compromised Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall DAILY DRIVELINE KIT Kit Code: DM940 - Product Usage: Kit is used for Driveline Maintenance and Securement of… Potential for sterile packaging to be compromised Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall HIGH DRAINAGE LVAD TRAY Kit Code: DM950 - Product Usage: Kit is used for Driveline Maintenance and Securement… Potential for sterile packaging to be compromised Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall DRIVELINE MANAGEMENT TRAY Kit Code: DT17780B - Product Usage: Kit is used for Driveline Maintenance and… Potential for sterile packaging to be compromised Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall DRIVELINE MANAGEMENT SYSTEM 1 DAILY Kit Code: DT18440A - Product Usage: Kit is used for Driveline Maintenance… Potential for sterile packaging to be compromised Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall UNIVERSAL BLOCK TRAY Kit Code: MNS6645 - Product Usage: Kit is used for regional anesthesia nerve blocks for… Potential for sterile packaging to be compromised Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall LACERATION TRAY Kit Code: SUT18370 - Product Usage: Kit is used for laceration repairs for general population. Potential for sterile packaging to be compromised Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall SNAG FREE SUTURE TRAY Kit Code: SUT14355 - Product Usage: Kit is used for laceration repairs for general… Potential for sterile packaging to be compromised Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall VITROS 250 Chemistry System, clinical chemistry analyzer Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System Class IIFDA’s classAug 14, 2019in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2019ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico 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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