Medical devices, 2015
Shortlist up to four to read them side by side.
2,495 medical device recalls FDA’s Enforcement Report published in 2015, 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.
2,495of 2,495 medical device recallsshown with your filters
The list
- Medical device recall ANSPACH -4MM Coarse Diamond Ball, 22MM Shaft Exposure G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 4MM Diamond Ball, Extends 27MM G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 5MM Fluted Ball, 2MM Shaft Exposure G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 5MM Diamond Ball, 2MM Shaft Exposure G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 5MM Coarse Diamond Ball, 22MM Shaft Exposure G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 2.3MM Fluted Matchstick, Extends 22MM G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ANSPACH - 3MM Fluted Matchstick, Extends 8.9MM, Less Aggressive G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania and Texas
- Medical device recall ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1 Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Aequalis Humeral Nail Targeting Jig Recall for the Aequalis IM Nail instrumentation set (Tray Number 9020000) due to several reports that the mast of the targeting jig (Part Number 9020060) is… Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Maryland, Maine, Michigan, Missouri, North Carolina, Ohio, Pennsylvania and Texas
- Medical device recall SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP Lack of sterility assurance. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereAlabama, California, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, Mississippi, Nevada, New York, Ohio, Pennsylvania, Texas, Utah and Virginia
- Medical device recall ACUSON S2000 and ACUSON S3000 ultrasound systems with the Virtual Touch IQ option Potential measurement error on ACUSON S Family ultrasound system. Class IIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage: The Breath Alcohol… Acon Laboratories, Inc. Class IIIFDA’s classAug 5, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedAug 5, 2015ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, California, Florida, Georgia, Louisiana, Michigan, Minnesota, New Jersey, New York, Ohio, Pennsylvania, Texas, Utah and Virginia named
- Medical device recall PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachi PROBEAT with DSSS is a medical device… At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportTexasthe one state its words name PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 29, 2015in FDA’s Enforcement Report47 statesnamed in where it went PublishedJul 29, 2015ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, 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
- Medical device recall Safety PICC Insertion Tray with Chloraprep OneStep An INCORRECT item number is packed within the OUTSIDE “PIGGYBACKED” PACKAGE. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportConnecticutthe one state its words name PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereConnecticut
- Medical device recall Magnus Hybrid OR Table Column There is a potential issue that could result to collision between the C-arm of the angiography system and the MAGNUS OR table system. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Milex Vaginal-Hymenal Silicone Dilators Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex… Incorrect expiration date on outer carton kit label Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Hawaii, Illinois, Kentucky, Maryland, Minnesota, North Carolina, New York, Ohio, Texas and Vermont named
- Medical device recall 0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to complaints related to installation failures of the Neptune 2… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement Report49 statesnamed in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereAlaska, 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, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are… Cook Inc. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of… Cook Inc. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable… Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for for the stylet to eject from the SelectCore… Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and Mississippi, New Jersey and Texas named
- Medical device recall Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for… Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Natrelle CUI Series Tissue Expanders Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND… Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible… Devon Light Gloves contain splits or holes compromising the sterility Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Devon Light Gloves contain splits or holes compromising the sterility Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Mini-Kits, Sterile-Kits containing the Devon Light Glove Devon Light Gloves contain splits or holes compromising the sterility Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Devon Light Gloves contain splits or holes compromising the sterility Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Devon Light Gloves contain splits or holes compromising the sterility Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Devon Light Gloves contain splits or holes compromising the sterility Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Surgical Kit Sterile-Kits containing the Devon Light Glove Devon Light Gloves contain splits or holes compromising the sterility Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Devon Light Gloves contain splits or holes compromising the sterility Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Major Kit, Sterile-.Kits containing the Devon Light Glove Devon Light Gloves contain splits or holes compromising the sterility Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Devon Light Gloves contain splits or holes compromising the sterility Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Devon Light Gloves contain splits or holes compromising the sterility Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Devon Light Gloves contain splits or holes compromising the sterility Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Non Sterile Subassembly Devon Light Gloves contain splits or holes compromising the sterility Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall Hysto Pack, Non-sterile Devon Light Gloves contain splits or holes compromising the sterility Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall GE Healthcare Precision 500D Classical R & F system. A reported incident of a monitor that fell from the suspension. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Guam named
- Medical device recall GE Healthcare Precision RXi 23A/32A Analog System A reported incident of a monitor that fell from the suspension. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Guam named
- Medical device recall GE Healthcare Precision RXi Digital system A reported incident of a monitor that fell from the suspension. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Guam named
- Medical device recall GE Healthcare, Precision MPi fluoroscopic imaging systems. A reported incident of a monitor that fell from the suspension. Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Guam named
- Medical device recall Perkin Elmer WIZARD2 1-detector, 550 samples Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall WIZARD2 2-detector, 550 samples Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall WIZARD2 5-detector, 550 samples Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perkin Elmer WIZARD2 10-detector, 550 samples Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perkin Elmer WIZARD2 5-detector, 1 000 samples Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perkin Elmer WIZARD2 10-detector, 1000 samples Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Class IIFDA’s classJul 29, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 29, 2015ClassClass IIStatusTerminatedWhereNationwide
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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