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 NEUROPATH 5Fx100 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 5Fx90 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 6Fx90 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 5Fx90 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 6Fx90 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 6Fx90 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 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 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 Merit Medical Systems Inc., Resolve Biliary Locking Drainage Catheter, Models RBC and RBDC, used for drainage… A consumer complaint that a catheter was observed to be in several pieces under patient fluoroscopic visualization. Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereArizona, Florida, Georgia, Missouri, New Jersey and Utah
- Medical device recall Varian Eclipse Treatment Planning System for Radiotherapy The calculation of dose dynamic plans containing different energy fields is incorrect when the Pencil Beam Convolution 11.0 algorithm (PBC 11.0) is used. Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MAYFIELD¿ Composite Series Base Unit Standard Integra determined there is a possibility that the Base Units may break during use. Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement Report32 statesnamed in where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall MEDRAD Hand Controller Sheath The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the… Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips HeartStart XL+ Defibrillator/Monitor Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Liko Overhead Rail System, Ceiling Mounted Rail Systems for all Liko Stationary Lifts including Likorall,… Liko/Hill-Rom to date has received two reports from facilities alleging that the overhead rail system has failed to the extent that the overhead rails have… Class IIFDA’s classFeb 27, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedFeb 27, 2013ClassClass IIStatusTerminatedWhereNationwide, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15” camera systems These camera systems were manufactured by LMGS and found to fail to comply with the FDA laser performance standard during an FDA inspection. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The T-piece Resuscitation System [ventilator,… Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 20, 2013in FDA’s Enforcement Report31 statesnamed in where it went PublishedFeb 20, 2013ClassClass IStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall Giraffe and Panda Bag and Mask Resuscitation System The T-piece Resuscitation System [ventilator, emergency… Oxygen and air wall inlet fittings on the back panel of the resuscitation systems were reversed during assembly. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 20, 2013in FDA’s Enforcement Report31 statesnamed in where it went PublishedFeb 20, 2013ClassClass IStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Iowa, Idaho, Illinois, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Texas, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall St. Jude Medical, AGA Medical corporation, AMPLATZER¿ TorqVue¿ FX Delivery System. Model #’s:… The distal end of the core wire of the TorqVue FX Delivery System could potentially fracture when exposed to a combination of certain cardiac anatomies and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 40 states named PublishedFeb 20, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall The Lumenis VersaCut Tissue Morcellator Product Usage: is intended for use under direct or endoscopic… Lumenis Ltd is recalling certain models of VersaCut Morcellator devices to perform corrective labeling as a result of three reported events of air embolism… FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedFeb 20, 2013ClassClass IStatusTerminatedWhereNationwide, and Alaska, Arizona, California, Florida, Iowa, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Mindray DS USA, Inc., DPM Central Monitoring System with ambulatory Telepack Mindray has identified a software anomaly that may where, in the presence of an asystole, the Telepack ECG waveform may produce a unique step pattern (instead… Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fresenius Liberty Cycler Set Single Conn There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty Expired product was shipped to two customers. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia and Texas named
- Medical device recall The product is a lyophilized growth supplement for use with dehydrated culture media to prepare BCYE Medium… The product may contain low level microbial contamination which could result in incorrect results. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereIllinois, Indiana and Michigan
- Medical device recall Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System Inaccurate readings. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date:… The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained… Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BREG Sterile Polar Pads The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained… Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Aesculap(R) - Miethke Shunt System, FT040T - Control Reservoir Set w/Distal Catheter and FT075P 0 Ventric… The deflector may not move freely on the ventricular catheter. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Michigan, Pennsylvania and Texas named
- Medical device recall Remel Xpect Clostridium difficile Toxin A/B, IVD, 20 clostridium difficile toxin A/B tests The firm is recalling the products due to a potential for false negative test results. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Remel Xpect Clostridium difficile Toxin A/B, IVD, 40 clostridium difficile toxin A/B tests The firm is recalling the products due to a potential for false negative test results. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Oxoid Antimicrobial Susceptibility Discs, Cefoxitin 30ug The firm is recalling the product because the cartridges may contain discs that have an insufficient dose of antibiotic. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Georgia, Iowa, Kansas, Oklahoma, Rhode Island, Texas, Washington and Wisconsin named
- Medical device recall Chenica Gunnell Rehab Series of Wheelchairs (GRSW) The wheelchairs may not meet the specifications of WC-19 (crash testing), therefore the WC-19 verbiage and corresponding logo are removed from the flyers on… Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Illinois, Massachusetts, Maryland, Michigan, New York, Ohio, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall Mizuho Orthopedic Table Possible instability of Orthopedic Table Top. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement Report48 statesnamed in where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereAlaska, 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, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material Incorrect packaging of regular set and fast set cartridges. Class IIIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material Incorrect packaging of regular set and fast set cartridges. Class IIIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare, Dash 3000, Dash 4000 and Dash 5000 Physiological Patient Monitor and accessories. GE has become aware of multiple issues affecting the Dash 3000/4000/5000 Patient Monitor. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia, Georgia, Indiana and Puerto Rico named
- Medical device recall GE Healthcare, Dash Port 2 Docking Station GE has become aware of multiple issues affecting the Dash 3000/4000/5000 and DashPort 2 monitor. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall Cloth electrodes with Carbon construction: P/N 201-1231 Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereGeorgia and Tennessee
- Medical device recall Cloth electrodes with Silver-Carbon construction: P/N 202-9231 Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereGeorgia and Tennessee
- Medical device recall Foam Electrodes with Carbon construction: P/N 201-1261 Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereGeorgia and Tennessee
- Medical device recall Foam electrodes with Silver-Carbon construction: P/N 202-9271 Electrode Socket Terminal pulling away from the electrode lead wire when the electrical stim lead wire was removed. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereGeorgia and Tennessee
- Medical device recall Quidel, Sofia Influenza A + B FIA, Kit #20218 Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to… Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Viterion TeleHealth Monitor Viterion telehealth monitors do not transmit “HI” (above the meter’s measurable range) and “LO” (below the meter’s measurable range) blood glucose readings… Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Viterion TeleHealth Monitor Viterion telehealth monitors do not transmit “HI” (above the meter’s measurable range) and “LO” (below the meter’s measurable range) blood glucose readings… Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Viterion TeleHealth Monitor Viterion telehealth monitors do not transmit “HI” (above the meter’s measurable range) and “LO” (below the meter’s measurable range) blood glucose readings… Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare, CARESCAPE Monitor B650 GE Healthcare has become aware of potential issues associated with the CARESCAPE Monitor B650. Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement Report32 statesnamed in where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin
- Medical device recall Philips Healthcare SureSigns VS2+ VS2+ screen may lock up and stop monitoring during patient use Class IIFDA’s classFeb 20, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 20, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film Missing symbols and manufacturing information on the clear carton label. Class IIIFDA’s classFeb 13, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 13, 2013ClassClass IIIStatusTerminatedWhereNationwide, and California, Florida, Illinois, Indiana, Maryland, Pennsylvania and Texas 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.”
Your shortlist0 of 4
Add one more to compare.