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 6, 2026.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall Excella II Standard Pedicle Screw Innovasis is recalling the Excella II Standard Pedicle Screw due to mislabeling of the size and catalog number. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Kansas, Minnesota, Oklahoma and Texas named
- Medical device recall Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not… Class IIFDA’s classJul 23, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereCalifornia and New York
- Medical device recall Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set There is a potential for a leak. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens RAPIDComm¿ Data Management System RAPIDComm¿ 5.0 Screen Layout will display incorrect test names Class IIIFDA’s classJul 23, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 23, 2014ClassClass IIIStatusTerminatedWhereOregon and Pennsylvania
- Medical device recall Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Kits because of revised labelling to indicate they are unsafe in an MR… Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall LP,Surgical Fibers, Bare Laser Fiber 600 micron, DBLF-60-2, Sterile EO Laser Peripherals LLC is recalling DBLF-60-2 Bare Laser due to a mislabeling that indicated a sterility expiration date as ‘2016-16’ as opposed to the intended… Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Indiana and Maryland named
- Medical device recall Baxter MiniCap with Povidone-Iodine Solution, 5C4466P, Baxter Healthcare Corporation Inadequate iodine and packaging related defects. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Siemens syngo RT Dosimetrist 2.7 system Product Usage: The intended use of syngo Suite for Oncology Systems… An update to the Virtual Simulation software of the syngo RT Dosimetrist is necessary to address a safety issue. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and New Hampshire, Ohio, Tennessee, Texas and Virginia named
- Medical device recall Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile Lack of Sterility Assurance Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereNationwide, and Florida and Texas named
- Medical device recall Spacelabs Healthcare Ultraview SL Multigas Module With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement ReportGeorgiathe one state its words name PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereGeorgia
- Medical device recall Titan T 5K Motor Product Usage: Low-speed motor is used with various attachments to perform a variety of… The housing of 5K motor was laser marked incorrectly as a 20K motor. Class IIFDA’s classJul 23, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 23, 2014ClassClass IIStatusTerminatedWhereCalifornia, Indiana, Minnesota, New York, Tennessee, Utah and Washington
- Medical device recall Amerigel Wound Dressing 1 oz Product may not have been manufactured pursuant to a validated process protocol and CGMP. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereFlorida and New Jersey
- Medical device recall Amerigel Wound Dressing 55 gallons/drum Product may not have been manufactured pursuant to a validated process protocol and CGMP. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereFlorida and New Jersey
- Medical device recall Patient Side Cart Battery Box used in conjunction with the da Vinci A surgical system Patient Side Cart battery boxes may overheat in rare charging conditions, causing battery bulging. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall HLD System, Model 610, Medical Device Cleaning and High Level Disinfection Washer/Pasteurizer. The temperature sensor/control system in the HLD Systems Model 610 may provide a false temperature reading. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Delaware, Florida, Massachusetts, Michigan, New York, Pennsylvania, Texas, Utah, Washington and Wisconsin named
- Medical device recall Henora REF: 70-4026-09V1 300psi I.V. Catheter Extension Set Product Usage: Catheter extension set for high… Problem with low adhesion of the tubing to luer connection which may lead to a separation of the extension set while in use. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Delaware, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, New Jersey, New Mexico, Nevada, New York, Ohio, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Devon Supine, Lithotomy and Trendelenburg Positioning Kit Straps may separate from the foam pad. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, District of Columbia, Florida, Illinois, Indiana, Kansas, Kentucky, Maine, Michigan, Minnesota, Missouri, Mississippi, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Texas and Virginia named
- Medical device recall 07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4 Report of the product penetrating the sterile barrier; this could render the product unsterile. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall 07-150-10 MIZUHO, DOPPLER PROBE, SLIM, BX 4 Report of the product penetrating the sterile barrier; this could render the product unsterile. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall 07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4 Report of the product penetrating the sterile barrier; this could render the product unsterile. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall VTI BAYONET DOPPLER, 20MHz DOPPLER PROBE, SLIM, BX 4 Report of the product penetrating the sterile barrier; this could render the product unsterile. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall 3M Attest Auto-reader Labeling on units shipped prior to May 16th, 2014 did not contain the statement “This product contains dry natural rubber” as required by the United States… Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Aquapak 340 SW, 340, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor . The seals of the respiratory gas humidifier adaptor packaging may be creased which may potentially affect packaging integrity. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aquapak 640 SW, 650, mL w/040 Adaptor, International, Teleflex Medical, respiratory gas humidifier adaptor . The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aquapak 101 SW, 190, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aquapak 340 SW, 340, mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor. The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aquapak SW/EAU, Sterile, 340 mL, w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor. The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aquapak 340 SW, 340, mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor. The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aquapak 340 SW, 340, mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor. The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aqua 540 SW, 540 w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor. The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aquapak SW/EAU Sterile, 650 mL w/Adaptor, Teleflex Medical, respiratory gas humidifier adaptor. The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aquapak 640 SW, 650 mL w/040 Adaptor, Teleflex Medical, respiratory gas humidifier adaptor. The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aquapak 640 SW, 650 mL w/040 Adaptor, French, Teleflex Medical, respiratory gas humidifier adaptor. The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aquapak 640 SW, 650 mL w/040 Adaptor, Japan, Teleflex Medical, respiratory gas humidifier adaptor. The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Adaptor, 040 Hum, International, Teleflex Medical, respiratory gas humidifier adaptor. The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Humidifier Adaptor 040, Teleflex Medical, respiratory gas humidifier adaptor. The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Humidifier Adaptor, 040 Shelf Pak, French, Teleflex Medical, respiratory gas humidifier adaptor. The seals of the adaptor packaging may be creased which may potentially affect packaging integrity. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo¿ Advanced Perfusion System 1 100/120V AC, Advanced Perfusion System Platform (APS) An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Terumo¿ Advanced Perfusion System 1 220/240V AC, Advanced Perfusion System Platform (APS) An evaluation of the APS1 Operator Manual found that existing instructions lack clarity and accuracy related to specific items. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Intuitive Surgical Inc Manufacturing variation in the grip assembly of the Large Clip applier which can lead to the instrument jamming during insertion when used with the 8 mm… Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall STOPCOCK EXT Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled in the reverse position, resulting in the stopcock being… Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Illinois, Kansas, Louisiana, North Carolina, Nebraska, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Aquatec Fixed Backrest - accessory for Mobile Shower and Toilet commode Aquatec Ocean, Ocean VIP and Ocean… The Aquatec¿ Fixed Backrest withstands a load of only 250 newtons at uneven load. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 16, 2014ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall Dafilon Suture Black 10/0 Aesculap Inc. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereGeorgia, Illinois, New York and Rhode Island
- Medical device recall SmartSite Low Sorbing Infusion Set CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereFlorida, New Mexico, Texas, Washington and Wisconsin
- Medical device recall The STERIS 4085 General Surgical Table Product Usage: is an electro-hydraulically operated surgical table… STERIS engineering analysis has determined the D1 pressure switch in the hydraulic column manifold does not adequately detect pressure level. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide, 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 The Hospira MedNet Medication Management Suite (MMS) Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosing units of “nanog/kg/min” and “milliUnits/min” are not sent to a Plum A+ device… Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and Florida, Louisiana, Pennsylvania, Washington and Wyoming named
- Medical device recall GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (pain management) List number 13150 The connection between the beeper subassembly and the pump may fail. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedJul 16, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM… Two lots of screws were commingled. Class IIFDA’s classJul 16, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 16, 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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