Medical devices, 2013
Shortlist up to four to read them side by side.
2,249 medical device recalls FDA’s Enforcement Report published in 2013, 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.
2,249of 2,249 medical device recallsshown with your filters
The list
- Medical device recall ViSi Mobile Chest Sensor Sotera Wireless, Inc. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereCalifornia and Utah
- Medical device recall Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile On March 28, 2013, Custom Spine, Inc. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide, and Nebraska and Virginia named
- Medical device recall LPS Lower Extremity Dovetail Intercalary component The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the female component when exposed to certain physiological loads. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 7, 2013in FDA’s Enforcement Report17 statesnamed in where it went PublishedAug 7, 2013ClassClass IStatusTerminatedWhereFlorida, Georgia, Idaho, Kansas, Kentucky, Michigan, Missouri, North Carolina, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Virginia and Washington
- Medical device recall Synthes Synapse SD Drill Guide A complaint was received from the field, that the drill guide was etched incorrectly, 12mm etch instead of 18mm drill guide. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedAug 7, 2013ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall Medline Steam Biological Indicators, SteriTec Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardinal Steam Biological Indicator, SteriTec Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EZTest Steam Biological Indicator, SteriTec Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Getinge Assure Accufast BI Test Pack w/ 5 Controls, SteriTec Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mesa Labs Smart-Read 10^5 EZ Test BI Test Pack, SteriTec Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medline Med-Checks BI Test packs with Instant Readout Integrator, SteriTec Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AIA Analyzer Pipette Tips used on Tosoh AIA-2000, AIA-1800, AIA-900 and AIA-600II Analyzers, 1000 tips/bag… Visual inspection of the pipette tips indicated that some of the tips were not uniform in size/length which was causing error messages on the analyzers. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement Report44 statesnamed in where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming
- Medical device recall uTASWako DCP Product fails to meet the accuracy at the low end of the measuring range. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Georgia, Minnesota, North Carolina and Utah
- Medical device recall Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue,… When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of the… Class IIFDA’s classAug 7, 2013in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereArkansas, California, Florida, New Jersey, New York, Oklahoma and Texas
- Medical device recall GE Healthcare, VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM GE Healthcare has recently become aware that during use of the Voluson E6 or E8 systems, that an error message Out of Memory can be displayed which could… Class IIFDA’s classAug 7, 2013in FDA’s Enforcement Report30 statesnamed in where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereAlaska, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Louisiana, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All Software Versions) The recall was initiated because Beckman Coulter has identified a software error on AU5800 analyzers with the Automation Ready (AR) Sampler Kit. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Eon Mini - 3788 (IPG), Eon Mini system is indicated as an aid in the management of chronic intractable pain… As part of St. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Omnicycle Elite An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GAMMA3 System Long Nail Kit, R2.0, Ti, Left Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereIllinois, Kentucky and Tennessee
- Medical device recall The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents,… The devices secondary audio signal fails to activate. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement Report22 statesnamed in where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Delaware, Florida, Hawaii, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, North Carolina, New Jersey, New York, Pennsylvania, South Dakota, Texas and Washington
- Medical device recall Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereCalifornia, Indiana, New Jersey and Oklahoma
- Medical device recall GE Healthcare, LOGIQ e Ultrasound System GE Healthcare became aware of a potential issue associated with the LOGIQ e system. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont and Wisconsin named
- Medical device recall syngo Dynamics Information System (sDIS) versions 9.5 and VA10A Siemens initiate this recall due to a potential issue when using the sDIS matching rules of the syngo Dynamics Information System version 9.5 or VA10A with… Class IIFDA’s classAug 7, 2013in FDA’s Enforcement Report7 statesnamed in where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereCalifornia, Missouri, New York, Ohio, Pennsylvania, Texas and Utah
- Medical device recall Inspira AIR Balloon Dilation system Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some… Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Inspira AIR Balloon Dilation system Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some… Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Inspira AIR Balloon Dilation system Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some… Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Inspira AIR Balloon Dilation system Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some… Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Inspira AIR Balloon Dilation system Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some… Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Inspira AIR Balloon Dilation system Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some… Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Inspira AIR Balloon Dilation system Labeling correction for all sizes of the Inspira AIR Balloon Dilation System to include additional language and warnings as well as to clarify some… Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM Mesa EZTest , Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the… Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM Self-contained steam biological indicator, are recalled because Mesa recently determined that the read out time is not in specification with the label claims. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Caddy - PedFuse, Screw Caddy, 8MM and 9MM Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that… Class IIFDA’s classAug 7, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereColorado, District of Columbia, Massachusetts and Texas
- Medical device recall S-LIFT Slap Hammer Malfunction of slap hammer. Class IIFDA’s classAug 7, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 7, 2013ClassClass IIStatusTerminatedWhereKansas and Texas
- Medical device recall AlboGraft Knitted with Collagen, Bifurcate 14x08 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall AlboGraft Knitted with Collagen, Straight 15x06 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall Albo Graft Knitted with Collagen, Bifurcate 16x08 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall AlboGraft Knitted with Collagen, Bifurcate 18x09 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall AlboGraft Knitted with Collagen, Bifurcate 18x10 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall AlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of… Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall AlboGraft Knitted with Collagen, Straight 40x07 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall AlboGraft Knitted with Collagen, Straight 40x08 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall AlboGraft Knitted with Collagen, Straight 60x06 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall AlboGraft Knitted with Collagen, Straight 60x07 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall AlboGraft Knitted with Collagen, Straight 60x08 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall AlboGraft Woven with Collagen, Straight 15x26 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall AlboGraft Woven with Collagen, Straight 15x30 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
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.”
Your shortlist0 of 4
Add one more to compare.