Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Ortho Pack, Kit number PSS3466 and PSS3466(A convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Pacemaker Kit, Kit number AMS4281 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Pelviscopy/Laparoscopy Pack, Kit number PSS3342 convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Percutaneous Entry Kit, Kit number TVS4022(C and TVS4022(D convenience custom kits used for general surgery… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Peri GYN, Kit number PSS2193(A convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Peri Kit, Kit number PSS1037 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Plastic General Pack, Kit number AMS4215 convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Plastic Kit, Kit number CMP1084(B convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Plastic Pack , Kit number AMS1833(A convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Podiatry Kit PSS1040(A, PSS1040(B, and PSS1040(C convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Podiatry Pack, Kit number AMS1541, AMS2778, PSS2645, and PSS3422 convenience custom kits used for general… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Robotic Pack, Kit number AMS4389 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Set Up Pack, Kit number PSS3574(A convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Set-Up Pack, Kit number PSS1305(B and PSS1305(C convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Shoulder Pack, Kit number AMS1372(A, AMS1372(B, AMS2335, AMS2335(A, AMS2936, AMS3638, AMS3711, AMS4212,… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Spine Pack, Kit number AMS3753 and AMS3783(A convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Student Pack-NS, Kit number PSS2788 convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Surgical Pack, Kit number PSS3540 and PSS3540(A convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Taymour GYN Pack, Kit number PSS2642 convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Total Hip Pack, Kit number PSS2956 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Total Knee Pack, Kit number AMS4010(A convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Transvaginal Pack, Kit number CMP1767 convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Universal Pack, Kit number AMS2036 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Upper Extremity Pack, Kit number AMS2536 and AMS2536(A convenience custom kits used for general surgery in… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Upper Torso Tray, Kit number PSS1554(B convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Vaginal Pack, Kit number AMS1722 convenience custom kits used for general surgery in hospital operating room The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Vein Kit - No Introducer TVS4027-NI(A convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Virginia Custom Pack, Kit number RMS1744 convenience custom kits used for general surgery in hospital… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Dr. Fritsch Pack, Kit number AMS2696 convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Laparoscopy Kit, Kit number PSS1038(A and PSS1038(B convenience custom kits used for general surgery in… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Mohs Closer Pack, kit number PSS1827(A, PSS1827(B, and PSS1827(C convenience custom kits used for general… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Port Access Kit, Kit number PSS1505(C convenience custom kits used for general surgery in hospital operating… The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, New Jersey, Nevada, Texas, Virginia and Wyoming named
- Medical device recall Vari-Safe Injection Needle US endoscopy 5976 Heisley Road Mentor, Ohio 44060 A sterile, single use, flexible… US Endoscopy is conducting a voluntary product recall of one lot of the Vari-Safe Injection Needle as it was identified that the lot was incorrectly… Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereOhio, Oregon and Washington
- Medical device recall RTI Surgical Streamline OCT Occipito-Cervico-Thoracic Spinal Rod, CoCr, 3.2mm (D) x 240mm (L) Product Usage:… RTI Surgical Inc. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Indiana, Michigan, Missouri, Mississippi, North Carolina, New York, Oklahoma, Tennessee, Texas and Virginia named
- Medical device recall Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part:… Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX Class IIFDA’s classOct 26, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fusion Workstation. After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereArizona, California, Idaho, Illinois, Indiana, Michigan, Minnesota and New Jersey
- Medical device recall Endoscopic Articulating Linear Cutter, ATB35 Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report37 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Rhode Island, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall Endoscopic Articulating Linear Cutter, 38ATW35 Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. Class IIFDA’s classOct 26, 2016in FDA’s Enforcement Report37 statesnamed in where it went PublishedOct 26, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Rhode Island, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin
- Medical device recall HeartWare Ventricular Assist System (HVAD), US product Foreign material found within the driveline connector of the HVAD Pump that could cause increased impedance resulting in electrical faults. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 19, 2016in FDA’s Enforcement Report26 statesnamed in where it went PublishedOct 19, 2016ClassClass IStatusOngoingWhereAlabama, Arkansas, Arizona, California, District of Columbia, Florida, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia and Wisconsin
- Medical device recall The Medix NatalCare LX Intensive Care Incubator NatalCare LX incubators may have a defective base where the weld holding the wheel bushing to the tube is inadequate. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Mississippi, New Jersey, New York, Oklahoma, Pennsylvania, South Carolina and Virginia
- Medical device recall The Better-Bladder With 14” ID tubing, ITEM BB14, STERILE, Measure pressure noninvasively in the… Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm. Class IIIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedOct 19, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kentucky, Louisiana, Michigan, Mississippi, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas and Virginia named
- Medical device recall Teleflex Percuaneous Solutions, Gripper Grasper The product is being recalled due to a labeling error. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereArizona, California, Florida, North Carolina, New York and Texas
- Medical device recall Teleflex Percuaneous Solutions, Johans Grasper The product is being recalled due to a labeling error. Class IIFDA’s classOct 19, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedOct 19, 2016ClassClass IIStatusTerminatedWhereArizona, California, Florida, North Carolina, New York and Texas
- Medical device recall Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal… Class IIFDA’s classOct 19, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 19, 2016ClassClass 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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