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 Philips Medical Systems, GEMINI LXL Software anomaly. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement Report43 statesnamed in where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, 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 and West Virginia
- Medical device recall Philips Medical Systems, GEMINI TF Big Bore Software anomaly. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement Report43 statesnamed in where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereAlaska, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, 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 and West Virginia
- Medical device recall Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 When the operator for a wall stand view selects an “image rotation” different from default, or such image rotation is preset in the examination database, then… Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Elekta, Apex add-on Micro MLC, collimator for radiation therapy. If the Apex collimator is incorrectly installed on the radiation head, a touchguard inhibit activates the view restrictions dialog box only shows the top 12… Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Texas named
- Medical device recall Integra(R) Jarit(R) Monopolar Cable (Catalogue No. 600-290) Addendum to the Instructions for Use. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aesculap Bipolar Generator Foot Pedal The bipolar energy did not stop after release of the foot pedal. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Florida, Iowa, Indiana, Kansas, Maryland, Minnesota, Missouri, Oregon, Tennessee, Texas, Virginia and Washington named
- Medical device recall VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collection Tubes due to potential contamination. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Out of specification result - stability test failure of free available chlorine (FAC) which functions as a preservative for the hydrogel. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Technocut Plus, Sterile Single Use Safety Scalpel Pouch labeling/printing errors and defective packaging resulting in possible compromised sterility. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement Report11 statesnamed in where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Michigan, Missouri, New York, Ohio, Pennsylvania, South Carolina, Tennessee and Wisconsin
- Medical device recall Stryker XIA 3 Iliac Screwdriver, 3-PCS Surgeons have experienced unthreading of the screwdrivers outer shafts during use. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah and Wisconsin named
- Medical device recall Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG Unintended Fluid ingress into the device header has been shown. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Orthofix ISKD Limb Lengthener There is a possibility that the ISKD limb lengthener may stop distracting post-operatively during treatment, which may result in premature bone consolidation… Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Firebird Spinal Fixation System, Parallel Rod Connector There is a possibility that the Set Screw (p/n 90-2923) sub-component of the Parallel Rod Connector Assembly (p/n 52-6800) & Axial Rod Connector (p/n 52-6700)… Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Ingenuity TF PET/CT The system may not default to the same gating trigger with which the data were acquired. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportOhiothe one state its words name PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereOhio
- Medical device recall REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T The affected product was packaged with the incorrect introducer needle. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall Philips MX 16-Slice CT Scanner System, a whole-body computed tomography X-ray system. The four screws that secure the patient table top to the carrier became loose, which caused the table top to detach. Class IIFDA’s classMar 6, 2013in FDA’s Enforcement Report18 statesnamed in where it went PublishedMar 6, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Georgia, Illinois, Indiana, Kentucky, Michigan, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, Puerto Rico and Virginia
- Medical device recall HealthTronics Endocare 3.8mm RenalCryo Cryoprobe, R3.8L The Endocare 3.8mm RenalCryo Cryoprobe is being recalled because the label on the outer box has the incorrect expiration date. Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Georgia, North Carolina, New Jersey, Ohio, Texas and Wisconsin named
- Medical device recall ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP, REF/Catalog Number 7-100-8BX, Disposable Hyfrecator(R) Tips,… Some devices had broken through the seal of the sterile pouch. Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT, REF/Catalog Number 7-101-8BX, Disposable Hyfrecator(R) Tips,… Some devices had broken through the seal of the sterile pouch. Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an… DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedFeb 27, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an… DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedFeb 27, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an… DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedFeb 27, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall LPS Diaphyseal Sleeves Product Usage: The LPS Diaphyseal Sleeves are used with the LPS System which is an… DePuy Orthopaedics is initiating a voluntary recall of the LPS Diaphyseal sleeve because the product has the potential for fracture at the taper junction. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedFeb 27, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Mexico, Nevada, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall CareFusion SmartSite Gravity Blood Set CareFusion is recalling the SmartSite¿ Gravity Blood Set as a result of a potential for separation at the connection of the drip chamber and tubing . Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Illinois, Missouri, Nevada, New York, Texas and Utah named
- Medical device recall VACUETTE Safety Blood Collection Set + Luer Adapter, 23x12” Safety Blood Collect LA Product The VACUETTE Safety Blood Collection Set + Luer Adapter may display leaking (small droplets) during use due to a crack on the luer connector piece. Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois, Kentucky, North Carolina, New York, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall Animas(R) 2020, Animas(R) IR 1250 Due to an internal calendar date limit (December 31, 2015) these pumps will cease to operate on January 1, 2016, and will result in a call service alarm that… Class IIIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedFeb 27, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Pro Time Microcoagulation System/ Pro Time 3 Cuvette, Pro3-4, Pro3-25, and Pro3-50 Some Pro Time3 Test Cuvettes within a specified lot range may recover lower than expected Prothrombin Time/International Normalized Ratio (PT/INR) results. Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LifeStyles ZERO 10 uber-thin lubricated latex condoms Out of an abundance of caution, Ansell is implementing a voluntary recall of the Zero Latex Condom (regular) product. Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Maquet ELS Cannula 15 FR ELS 15 Fr Cannula could potentially contain an occluded arterial lumen. Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereArizona, Colorado, Florida, Tennessee and Texas
- Medical device recall STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external… Reports that the AC Power Adaptor may not operate due to wires coming loose in the unit. Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereArizona and New Jersey
- Medical device recall Monaco RTP System The beam is displayed at the “gantry” angle, but the dose is calculated at the “rotation_start” angle. Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Florida, North Carolina, New Jersey, Ohio, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall NEUROPATH 6Fx90 GUIDING CATH MPC Sterility of device may be compromised due to lack of packaging integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEUROPATH 5Fx90 GUIDING CATH S2 Sterility of device may be compromised due to lack of package integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEUROPATH 6Fx90 GUIDING CATH HH Sterility of device may be compromised due to lack of package integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEUROPATH 5Fx100 GUIDING CATH HH Sterility of device may be compromised due to lack of package integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEUROPATH 5Fx100 GUIDING CATH HH Sterility of device may be compromised due to lack of package integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEUROPATH 6Fx100 GUIDING CATH MPD Sterility of device may be compromised due to lack of package integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEUROPATH 5Fx100 GUIDING CATH MP Sterility of device may be compromised due to lack of package integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEUROPATH 6Fx100 GUIDING CATH ST Sterility of device may be compromised due to lack of package integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEUROPATH 5Fx100 GUIDING CATH S2 Sterility of device may be compromised due to lack of package integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEUROPATH 6Fx100 GUIDING CATH MC Sterility of device may be compromised due to lack of package integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEUROPATH 6Fx100 GUIDING CATH S2 Sterility of device may be compromised due to lack of package integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEUROPATH 5Fx100 GUIDING CATH MC Sterility of device may be compromised due to lack of package integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEUROPATH 5Fx90 GUIDING CATH MCV Sterility of device may be compromised due to lack of package integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEUROPATH 5Fx90 GUIDING CATH MPC Sterility of device may be compromised due to lack of package integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEUROPATH 6Fx100 GUIDING CATH MP Sterility of device may be compromised due to lack of package integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NEUROPATH 5Fx90 GUIDING CATH MPD Sterility of device may be compromised due to lack of package integrity Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass 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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