Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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 7, 2026.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall 8” (20 cm) Appx 0.43 ml, Smallbore Bifuse Ext Set w/2 NanoClave”, 2 Clamps, Luer Lock, Part No. A1000, Item… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 30” (76 cm) Appx 3.7 ml, Ext Set w/Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿ T-Connector,… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 120” 10 Drop Primary Set w/2 BCV-CLAVE¿, Remv 2 Gang CLAVE¿ Stopcock, Remv CLAVE¿ Stopcock, NanoClave¿… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 5” (13 cm) Appx 0.23 ml, Smallbore Ext Set w/NanoClave”, Clamp, Rotating Luer, Part No. A1000, Item No. Z3845… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 5” Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 5” Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Luer Slip ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 5” Smallbore Ext Set w/MicroClave¿ T-Connector, Clamp, Rotating Luer ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 28” (71 cm) Appx 1.0 ml, Smallbore Ext Set w/Anti-Siphon Valve, MicroClave¿ T-Connector, Clamp, Rotating… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 6.5” (16.5 cm) Appx 0.30 ml, Smallbore Pressure Infusion (400psig) Ext Set w/Remv MicroClave¿ Clear,… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 6” (15 cm) Appx 0.24 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, Clamp, NanoClave¿ T-Connector, Rotating Luer,… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 17 cm (7”) Smallbore Trifuse Ext Set w/3 NanoClave¿ ( Light Blue, Lavender Rings), 3 Anti-Syphon Valves,… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall Multiples Anspach Micro Curved Attachments (MCA) and Curved Burr Support S leves (Cutters and Attachments)… During a recent review of documentation Anspach determined that the current directions for use for the MCA cutting burrs and MCA Micro Curved Attachment do not… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Essenta DR, a Stationary x-ray system, X-ray system X-ray system C-arm casting may loosen and fall Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall FEM COND BUTTRESS PLT, RT. Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TIBIO FEM/FEM NAIL. Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DIST LAT FEM LOCK PLT, LT Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DIST LAT FEM LOCK PLT, RT Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ITST THREADED GUIDE PIN Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall NGK Stem Ext 24 x 245mm Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall FEM COND BUTTRESS PLT, LT Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall TIB NAIL Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor… Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators. Class IIFDA’s classJan 8, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereIndiana, Mississippi, Texas and Virginia
- Medical device recall Asante Comfort Infusion Set with 60cm tubing & 13mm cannula Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Asante Comfort Infusion Set with 60cm tubing & 17mm cannula Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Asante Comfort Infusion Set with 110cm tubing & 13mm cannula Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Asante Comfort Infusion Set with 110cm tubing & 17mm cannula Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Asante Conset Infusion Set with 60cm tubing & 6mm cannula Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Asante Conset Infusion Set with 60cm tubing & 9mm cannula Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Asante Conset Infusion Set with 110cm tubing & 6mm cannula Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Asante Conset Infusion Set with tubing & 9mm cannula Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Integra Camino Advanced Monitor with Waveform Display Integra became aware through a complaint from a single non-US customer that if the optional SYS/DIAS mode is used on CAM01 monitor that contains Mod 4… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B,… Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit. Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STERRAD Cyclesure Biological Indicator (BI Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VERIFY¿ Dual Species Self-Contained Biological Indicator STERIS has identified that the population of the G. Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, 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, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall RTC 25-C Inline Aerosol Tee Adapter Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error. Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall IntelliFill i.v Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the IntelliFill i.v. Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Florida, Illinois, Louisiana, Massachusetts, Maryland, Michigan, North Carolina, Nebraska, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas and West Virginia named
- Medical device recall CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented… Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement Report19 statesnamed in where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Kansas, Kentucky, Michigan, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin
- Medical device recall Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the… Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement Report19 statesnamed in where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Kansas, Kentucky, Michigan, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin
- Medical device recall Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose… Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement Report19 statesnamed in where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Florida, Kansas, Kentucky, Michigan, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Washington and Wisconsin
- Medical device recall Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4,… Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF)… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including… Merit Medical Systems, Inc. Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes Hand Switch - Electric Pen Drive Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SYSTEM 1E Liquid Chemical Sterilant Processing System Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the… Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AdvanDx Gram-Negative QuickFISH BC Kits incompatible with certain fluorescence microscope light sources Class IIIFDA’s classJan 8, 2014in FDA’s Enforcement Report9 statesnamed in where it went PublishedJan 8, 2014ClassClass IIIStatusTerminatedWhereCalifornia, Illinois, Indiana, Michigan, Missouri, New Jersey, New York, Ohio and Wisconsin
- Medical device recall The Centricity Laboratory System is intended to be an information system designed to support the clinical and… GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instrument Interface (IF) where free-text sent from IM is not being… Class IIFDA’s classJan 8, 2014in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedJan 8, 2014ClassClass IIStatusTerminatedWhereMinnesota
- Medical device recall G7 Acetabular Screw 6.5mmx35mm Investigation identified that the outer label, inner label, and patient label all have the incorrect diameter size of 10.5mm. Class IIFDA’s classJan 1, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 1, 2014ClassClass 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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