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 HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen Wound Dressings for… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall OraMem Absorbable Collagen Membrane OraMem¿ Absorbable Collagen Membrane is an absorbable, implantable… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall BioMend¿ Extend” Absorbable Collagen Membrane BioMend¿ Extend” Absorbable Collagen Membrane is an absorbable,… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Layershield Adhesion Barrier Matrix Layershield Adhesion Barrier Matrix is an absorbable implant for use as… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall BioMend Absorbable Collagen Membrane BioMend¿ Absorbable Collagen Membrane is an absorbable, implantable… Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Absorbable Collagen Sponge Provided As Intermediate to Another Company Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Curity I.V. Start Kit, Product ID: 80530 and Curity I.V. Start Kit Product ID: 8508. IV Start Kit. On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Class IIIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Curity Staple Remover Kit On March 26, 2013 Covidien received a recall notice from one of their suppliers CareFusion. Class IIIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Electrode, cutting, 24FR Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Electrode, cutting, 24FR Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Electrode, Coag, Pointed, 24FR Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Electrode, Coag, Ball End, 24FR Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Electrode, Roller Ball, 24FR Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Electrode, Barrel Bar, 24FR Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Electrode, Roller, Vaporization, 24FR Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Electrode, VaporCut, 24FR Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Loop, Cutting, 24FR Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Knife, Cold, Straight Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Electrode, Cutting, 24FR, 0.30MM Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Loop, Cutting, Angled 22FR Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PadPro(R) Adult Radiotransparent Multifunction Electrodes, REF/Catalog No. 2001M-C ConMed was notified by the contract manufacturer that their wire/connector supplier reported damage to the connector tooling which could pinch or compress the… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ, Innova 2121 IQ, Innova 3131 IQ , Innova 3100,… While performing a fluoroscopic examination on the GE Innova systems, there is a potential of nonrecoverable loss of imaging modes with no advance warning, due… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Guam, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming named
- Medical device recall Summit Medical, BL-2006, Myringotomy Lance (Juvenile) Blade, Sterile P, Summit Medical, Inc., 815 Northwest… Summit Medical has initiated a recall of Myringotomy Lance Blade (Juvenile) because the box contains the wrong blade. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereMississippi, New York, Pennsylvania and Texas
- Medical device recall QIAGEN artus CMV RG PCR ASR CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Florida, Georgia, Illinois, Massachusetts, Maryland and Michigan named
- Medical device recall QIAGEN artus CMV RG PCR ASR CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Florida, Georgia, Illinois, Massachusetts, Maryland and Michigan named
- Medical device recall Proplege Coronary Sinus Catheter Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports of blood leakage through the hemostasis valve in… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Kentucky, Louisiana, Maryland, Maine, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device) HeartWare, Inc. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Segmented Cylinder Applicator Set Segmented cylinder applicator set may slip during treatment, causing the delivery of radiation to areas outside the target. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Varian High Energy Clinacs, High Energy Accelerator, Radiation Treatment System Under certain conditions, photon beams in High Energy Clinacs may experience a gradual change in beam symmetry, potentially reaching an asymmetry of up to… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Fluoroscan Mini C-arm InSight, software versions 1.x, 2.x, 3.x The device is a Mini C-arm Fluroscopic Imaging… The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fluoroscan Mini C-arm InSight2, software versions 3.x, 4.0, 4.0.1, 4.0.2 The device is a Mini C-arm… The audible alarm to alert the operator when cumulative irradiation time reaches five minutes is not accurate and the total cumulative irradiation time is not… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Iris Diagnostics Division iQ Control/Focus Set The firm initiated this recall because complaints from customers reported that the recovery compared to assigned assay values is significantly below… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PROFILE-V MEDTOXScan Drugs of Abuse Test System Review of validation information and customer complaints which indicated preliminary screen positive results for cocaine that were not positive on confirmatory… Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Liquichek” ToRCH Plus IgM Control - Positive Liquichek ToRCH Plus IgM Control is intended for use as an… The Liquichek” ToRCH Plus IgM Control - Positive, contains detectable levels of HCV RNA which originated from the non-specific human IgM component used in the… Class IIIFDA’s classMay 22, 2013in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 22, 2013ClassClass IIIStatusTerminatedWhereMinnesota, New Mexico, New York, Oregon, Puerto Rico and Wisconsin
- Medical device recall DePuy LifeLiner Stick & Cut Resistant Gloves Rt, Lg LifeLiner Stick and Cut Resistant Gloves are being recalled because cases and individual glove packages were mispackaged, with right handed, large sized glove… Class IIIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 22, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Illinois, Minnesota, North Carolina, Nevada, Ohio, South Carolina, Tennessee and Washington named
- Medical device recall BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood Microbiological media may be contaminated with bacteria. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall BBL(tm) Trypticase (tm) Soy Agar with 5% Sheep Blood and MacConkey II-I Plate Microbiological media may be contaminated with bacteria. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall BBL(tm) CDC Anaerobe 5% Sheep Blood Agar Microbiological media may be contaminated with bacteria. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Guam, Puerto Rico and US Virgin Islands named
- Medical device recall 1-DAY ACUVUE MOIST Brand Contact Lenses, soft disposable contact lenses Limited number of individual contact lens packages may not have been completely sealed. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall ACUVUE ADVANCE Brand Contact Lenses with HYDRACLEAR, Soft, disposable contact lenses Limited number of individual contact lens packages may not have been completely sealed. Class IIFDA’s classMay 22, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMay 22, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Presource PBDS, Gyn Laparoscopy Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 15, 2013ClassClass IStatusTerminatedWhereArkansas, Mississippi, South Carolina and Tennessee
- Medical device recall A) Presource PBDS, Lap Chole, Kit, Clean Up Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 15, 2013ClassClass IStatusTerminatedWhereArkansas, Mississippi, South Carolina and Tennessee
- Medical device recall Presource PBDS, General Laparoscopy, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 15, 2013ClassClass IStatusTerminatedWhereArkansas, Mississippi, South Carolina and Tennessee
- Medical device recall Presource PBDS, Major Abdominal, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 15, 2013ClassClass IStatusTerminatedWhereArkansas, Mississippi, South Carolina and Tennessee
- Medical device recall Presource PBDS, Knee Arthroscopy, Kit, Circulator Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 15, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedMay 15, 2013ClassClass IStatusTerminatedWhereArkansas, Mississippi, South Carolina and Tennessee
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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