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 AlboGraft Woven with Collagen, Straight 30x16 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall AlboGraft Woven with Collagen, Straight 30x18 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall AlboGraft Woven with Collagen, Straight 30x24 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall AlboGraft Woven with Collagen, Straight 30x26 Blood blushing/leaking from the surface of the graft after implantation FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 31, 2013ClassClass IStatusTerminatedWherePennsylvania
- Medical device recall Spacelabs ARKON Anesthesia Workstation Spacelabs ARKON Anesthesia System is recalled due to software defect. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportSouth Carolinathe one state its words name PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereSouth Carolina
- Medical device recall Endopath Electrosurgery Probe Plus II, twelve The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, 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 The LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock… The LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Massachusetts, North Carolina, North Dakota, New York, Pennsylvania, Rhode Island, Texas, Washington and Wisconsin named
- Medical device recall PASCAL and PASCAL Streamline When using the “Favorites” function for saved settings, there is potential for a mismatch between displayed power and the actual power output. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic… Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation… Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L Product Usage: The… Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation… Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The… Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation… Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dermalight 80 The incorrect manual may have been packaged with this product. Class IIIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJul 31, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Louisiana, Massachusetts, Minnesota, Missouri, Mississippi, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Dermalight 80 The incorrect manual may have been packaged with this product. Class IIIFDA’s classJul 31, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 31, 2013ClassClass IIIStatusTerminatedWhereAlabama, California, Minnesota and North Carolina
- Medical device recall Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several minutes impacting wireless connectivity Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Myoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device The outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol… Class IIFDA’s classJul 31, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereCalifornia and Idaho
- Medical device recall ARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and… Siemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have… Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Rultract Retractor Ratchet Cover Plate The firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement Report27 statesnamed in where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, North Carolina, New Jersey, New Mexico, Nevada, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall HemosIL RecombiPlasTin 2G Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington and Wisconsin named
- Medical device recall Eon and Eon Mini charging system There is issues of warmth or heating at the implant site during charging for the Eon Mini implantable pulse generators (IPGs). Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide… A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed… Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Kentucky, Louisiana, Virginia and Wisconsin named
- Medical device recall GE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for… GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 31, 2013ClassClass IStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to… GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 31, 2013ClassClass IStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use… GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 31, 2013ClassClass IStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 31, 2013ClassClass IStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Discovery NM 630, dual detector free-geometry integrated nuclear imaging system GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 31, 2013ClassClass IStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 31, 2013ClassClass IStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Optima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine… GE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 31, 2013ClassClass IStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall TotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum… When the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame, and the mattress… Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Axiom Aristos MX Solid State Flat Panel Digital Imager Siemens issued a Field Safety Notice about the potential hazard to patients or operators when using the function “table top float” of the AXIOM Aristos MX. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation… Research Use Only (RUO) parameters were included in TEG 5000 User Manual. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips HeartStart MRx Monitor/Defibrillator The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect therapy, which may induce ventricular fibrillation. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD BBL Vancomycin Screen Agar, carton of 10 plates Microbiological identification media may exhibit reduced levels of Vancomycin. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates Microbiological identification media may exhibit reduced levels of Vancomycin. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV) Microbiological identification media may exhibit reduced levels of Vancomycin. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar Microbiological identification media may exhibit reduced levels of Vancomycin. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV Microbiological identification media may exhibit reduced levels of Vancomycin. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV) Microbiological identification media may exhibit reduced levels of Vancomycin. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD BBL BCYE Selective Agar with PAV Microbiological identification media may exhibit reduced levels of Vancomycin. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BBL Campylobacter CSM Agar (Charcoal-Based Selective Medium) Microbiological identification media may exhibit reduced levels of Vancomycin. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or… Aesculap Implant Systems, LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant - 8 x 8.5 x 22 mm (SN038P) because the device is incorrectly… Class IIFDA’s classJul 31, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereMichigan and Nevada
- Medical device recall Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair Etac is voluntarily conducting a field correction of the Etac Swift Mobil shower chair. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm The device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same… Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Advanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in… Unapproved medical device Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Idaho, Kentucky, Maryland, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Virginia and Washington named
- Medical device recall Medtronic Preimplantation Test Kit Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer carton had expiration dates that were incorrect. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade… Church and Dwight Co., Inc. Class IIFDA’s classJul 31, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJul 31, 2013ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Indiana, Kentucky, Maryland, Michigan, Minnesota, Missouri, New Jersey, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall MedStream Programmable Infusion Pump- Implantable for the intrathecal delivery of Baclofen or Morphine Miscalibrated Fill Level Sensor may affect dosing level FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 24, 2013ClassClass IStatusTerminatedWhereNationwide, and Florida, North Carolina, New Jersey and Texas named
- Medical device recall MedStream Programmable Infusion Pump , Implantable for the intrathecal delivery of Baclofen or Morphine Miscalibrated Fill Level Sensor may affect dosing level FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 24, 2013ClassClass IStatusTerminatedWhereNationwide, and Florida, North Carolina, New Jersey and Texas named
- Medical device recall Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or… The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. Class IIFDA’s classJul 24, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 24, 2013ClassClass IIStatusTerminatedWhereNationwide, and Connecticut, Delaware, New York and Pennsylvania 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.”
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