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 3i T3 Non-Platform Switched Tapered Implant Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored. Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall OSSEOTITE Tapered Certain Implant Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored. Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall OSSEOTITE Certain 2 Implant Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored. Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall Natus neoBLUE blanket LED Phototherapy system which includes the following items: 006224 neoBLUE blanket LED… neoBLUE blanket LED Phototherapy System is recalled because Natus has received feedback from some customers about early failure of the neoBLUE blanket system… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues. Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedApr 22, 2015ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401 A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402 A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403 A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Replace Select Tapered TiU WP 5.0x10mm, Article No. 29423 A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Replace Select Tapered TiU WP 5.0x13mm, Article No. 29424 A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NOBELREPLACE Tapered Groovy RP 4.3x8mm, Article No. 32215 A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216 A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223 A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103 A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105 A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC NP 3.5x10mm, Article No. 36700. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC NP 3.5x11.5mm, Article No. 36701. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC NP 3.5x13mm, Article No. 36702. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC RP 4.3x8mm, Article No. 36704. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC RP 4.3x10mm, Article No. 36705. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC RP 4.3x11.5mm, Article No. 36707. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC RP 4.3x13mm, Article No. 36708. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC RP 5.0x8mm, Article No. 36710. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC RP 5.0x10mm, Article No. 36711. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC RP 5.0x13mm, Article No. 36713. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC PMC NP 3.5x13mm, Article No. 37288. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC PMC RP 4.3x8mm, Article No. 37290. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC PMC RP 4.3x10mm, Article No. 37291. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC PMC RP 5.0x10mm, Article No. 37296. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NobelReplace CC PMC RP 5.0x13mm, Article No. 37298. A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. Class IIFDA’s classApr 22, 2015in FDA’s Enforcement Report2 statesnamed in where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereCalifornia and Massachusetts
- Medical device recall ProTrack Microcatheter Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Florida, Georgia, Kentucky, Massachusetts, Michigan, Missouri, New York, Ohio, Oregon, Texas and Wisconsin named
- Medical device recall Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety… Potential for inadvertent scalpel stick injury involving the safety scalpel. Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hardy Diagnostics The firm is recalling HardyCHROM SS, Cat. Class IIFDA’s classApr 22, 2015in FDA’s Enforcement Report6 statesnamed in where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereArizona, California, Iowa, Puerto Rico, Texas and Washington
- Medical device recall Artis Q/ Q zen systems potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connection in the equipment cabinet has not been installed correctly. Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LOW PROFILE NON-LOCK SCREW A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number: 131227222 Lot: RM105E) was anodized green and should have… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, Iowa, Illinois, Kentucky, Massachusetts, North Carolina, New York, Oklahoma, Pennsylvania, South Carolina, Texas, Utah and Washington named
- Medical device recall Bard Monopty Disposable Core Biopsy Instruments and Kits, Monopty 14g x 16cm Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpermMar Test 0.7ml Beads Particles Label on bottle: SpermMar Test IgA 0.7ml Beads/Particles-50 Tests IND The firm is recalling three batches (FP14A09, FP14A10, FP14A11) of SpermMAR IgA test due to new formulation causing the motility of sperm cells to reduce in… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportOregonthe one state its words name PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereOregon
- Medical device recall Magellan Robotic System Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall WALLACH LL 100 cryosurgical units: LL100 Cryosurgical Internal gas line may malfunction causing the line to burst under pressure. Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington and West Virginia named
- Medical device recall Master Drug Library Software version 8.0 Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump during programming may differ. Class IIFDA’s classApr 22, 2015in FDA’s Enforcement Report21 statesnamed in where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New York, Puerto Rico, South Dakota, Texas, Utah and West Virginia
- Medical device recall Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified as not meeting stability acceptance criteria for… Class IIFDA’s classApr 22, 2015in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Talon Grasping Device, 160 cm, US endoscopy A wire component on the distal grasping assembly of the device became detached.. Class IIFDA’s classApr 22, 2015in FDA’s Enforcement Report42 statesnamed in where it went PublishedApr 22, 2015ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Ebola IgX VP-40 Serum/Plasma/Blood Cassette LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 15, 2015ClassClass IStatusTerminatedWhereCalifornia
- Medical device recall Ebola GP IgX Blood, Serum, Plasma, Cassette LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 15, 2015ClassClass IStatusTerminatedWhereCalifornia
- Medical device recall Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette) LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 15, 2015in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 15, 2015ClassClass IStatusTerminatedWhereCalifornia
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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