Medical devices, 2012
Shortlist up to four to read them side by side.
1,310 medical device recalls FDA’s Enforcement Report published in 2012, 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 5, 2026.
1,310of 1,310 medical device recallsshown with your filters
The list
- Medical device recall Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is… Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up… Class IIFDA’s classOct 31, 2012in FDA’s Enforcement Report42 statesnamed in where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Biosense Webster MobiCath Bi-Directional Guiding Sheath We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Product may have wrong large product identification label with symbols on the box indicating a S90 VAPR Electrode instead of the VAPR 3.5 hook electrode Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Maryland, Michigan, Minnesota, New Jersey, New York, Ohio, Oregon, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall AquaLiner Hydrophilic Guidewire 0.035” X 260cm, Angle/ Regular Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get… Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNew York
- Medical device recall AquaLiner Hydrophilic Guidewire 0.035” X 260cm, Angle/ Stiff Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get… Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNew York
- Medical device recall AquaLiner Hydrophilic Guidewire 0.035” X 260cm, Straight/ Regular Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get… Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNew York
- Medical device recall AquaLiner Hydrophilic Guidewire 0.035” X 260cm, Straight/ Stiff Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get… Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNew York
- Medical device recall AquaLiner Hydrophilic Guidewire 0.035” X 180cm, Angle / Regular Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get… Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNew York
- Medical device recall 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair. A product complaint was received where a size 20 screw was labeled as size 30. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK Anchors are primarily used to… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are primarily used to… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK Anchors are primarily used to… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRALOK Anchors are primarily used to… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to re-attach soft tissue to… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are primarily used to… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anchors are primarily used to re-attach… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK Anchors are primarily used to… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985 SPIRALOK Anchors are primarily… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 SPIRALOK Anchors are… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 SPIRALOK Anchors are primarily… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 SPIRALOK Anchors are… Fracture of SPIRALOK Anchors post op, requiring patient revision Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution… The firm is issuing a field correction to the operators manual included with the 099 Repeater Pump because the Technical Manual was distributed with the device… Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gish 3/8 x 3/8” Straight Connector with Luer fitting Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Illinois, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Gish 3/8 x 1/2” Reducer Connector with Luer fitting Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Class IIFDA’s classOct 31, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedOct 31, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Illinois, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall AutoMate 1250 and AutoMate 2550 The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tubes being labeled with two different barcode labels on the… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hemorrhoidal Circular Stapler and Accessories 33mm Product Usage: The PROXIMATE HCS Hemorrhoidal Circular… Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE¿ PPH Hemorrhoidal Circular Stapler and Accessories 33mm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedOct 24, 2012ClassClass IStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Belmont Rapid Infuser, a Fluid Management System Leak from a saline bag caused saline to drip along the back of the Rapid infuser close to the Power Entry Module causing an electrical flash at the power entry… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel DxC 880i… The recall was initiated because Beckman Coulter has confirmed that the current sample syringe pump drive assemblies installed on DxC Integrated ystem with… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CPT Modular Stem Zimmer Inc. Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide, and Indiana and Oklahoma named
- Medical device recall CPT Hip System Femoral Stem Petite Zimmer Inc. Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide, and Indiana and Oklahoma named
- Medical device recall CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 Zimmer Inc. Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide, and Indiana and Oklahoma named
- Medical device recall “***PressFT***2.6 w/ Two #1 Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement Report17 statesnamed in where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Louisiana, Massachusetts, Maine, Michigan, Minnesota, New Jersey, New Mexico, New York, Pennsylvania, Texas, Utah and Washington
- Medical device recall “***PressFT***2.6 w/ One #2 Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement Report17 statesnamed in where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Louisiana, Massachusetts, Maine, Michigan, Minnesota, New Jersey, New Mexico, New York, Pennsylvania, Texas, Utah and Washington
- Medical device recall “***Press FT***2.6 w/ One #2 Linvatec Corporation DBA ConMed Linvatec in Largo, FL is recalling Press FT HI-FI Sutures (items NP 211, NP 212, NP 261, NP 262, NP211H, NP261H-all lot… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement Report17 statesnamed in where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Louisiana, Massachusetts, Maine, Michigan, Minnesota, New Jersey, New Mexico, New York, Pennsylvania, Texas, Utah and Washington
- Medical device recall “***PressFT***2.1 w/ Two #0 Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement Report17 statesnamed in where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Louisiana, Massachusetts, Maine, Michigan, Minnesota, New Jersey, New Mexico, New York, Pennsylvania, Texas, Utah and Washington
- Medical device recall “***PressFT***2.1 w/ One #2 Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement Report17 statesnamed in where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Louisiana, Massachusetts, Maine, Michigan, Minnesota, New Jersey, New Mexico, New York, Pennsylvania, Texas, Utah and Washington
- Medical device recall NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to… Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement Report17 statesnamed in where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Georgia, Louisiana, Massachusetts, Maine, Michigan, Minnesota, New Jersey, New Mexico, New York, Pennsylvania, Texas, Utah and Washington
- Medical device recall Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the… Backplate reservoir holders were manufactured with an incorrect configuration of connector supports. Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, Michigan, North Carolina, New Jersey, Pennsylvania and Wisconsin named
- Medical device recall ***This recall is being conducted due to an incomplete recall for RES 57829*** Curlin Infusion Administration… This recall is the same issue for the FDA processed recall initiated by Moog Medical Devices on 1/25/11 which was related to customers reporting unclearable… Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide, and California named
- Medical device recall Sunquest Laboratory : intended for use by professionals working in a clinical laboratory. Online calculations may not be performed as expected or may yield results that are different than expected when the calculation module is called from the… Class IIIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall “***Electric Systems Foot Control****Rx Only***” Product Usage: Cutting and shaping bone including bones of… The Anspach Effort, Inc. Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall “***Electric Systems Foot Control with Direction Only***Rx Only***” Product Usage: Cutting and shaping bone… The Anspach Effort, Inc. Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall “***Electric Systems Foot Control with Direction and Irrigation***Rx Only***” Product Usage: Cutting and… The Anspach Effort, Inc. Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Helion and Xenion surgical lights, 501/01 series KLM lights Incidents regarding fractures of the front joint of the spring arm have been reported. Class IIFDA’s classOct 24, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedOct 24, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Massachusetts, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, South Carolina, Texas, Utah, Vermont and Wisconsin 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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