Medical devices, 2012
Shortlist up to four to read them side by side.
1,310 medical device recalls FDA’s Enforcement Report published in 2012, 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.
1,310of 1,310 medical device recallsshown with your filters
The list
- Medical device recall TX1 Tissue Removal System Console Two reasons for recall. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Minnesota named
- Medical device recall Philips Digital Diagnost Software, software release 2.0.2 and 2.0.2SP1 including mirror icon Stationary… With Digital Diagnost (DIDI) R 2.0.2 a mirrored “R in a circle” is burnt into the image (if mirrored) in the lower right corner of the image. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling… Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling… Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Peak SE Primer Kits Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Missouri, North Carolina, New Hampshire, Nevada, Ohio, Pennsylvania, Texas, Virginia, Washington and Wisconsin named
- Medical device recall HEPARIN LOCK FLUSH SOLUTION, USP, 10 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL CGMP Deviations: Incomplete documentation associated with test results. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall HEPARIN LOCK FLUSH SOLUTION, USP, 100 USP Units/mL, 1 mL Multiple Dose Vial, plastic vial, vial size 3 mL CGMP Deviations: Incomplete documentation associated with test results. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection. On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certain Implant, Model # IOSM313, Lot #2010111529. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Multi Diagnost Eleva II with swivel cable MultiDiagnost Eleva X--Ray system may have damage to System Cables from repeated movement Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL… The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter Analyzer records. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Nevada and Vermont named
- Medical device recall SARNS HIGH-FLOW AORTIC ARCH CANNULA: 5.2 MM During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall SARNS HIGH-FLOW AORTIC ARCH CANNULA: 6.5 MM During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall SARNS FLEXIBLE ARTERIAL CANNULA: 6.7 MM During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall SARNS FLEXIBLE ARTERIAL CANNULA: 7.3 MM During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall SARNS FLEXIBLE ARTERIAL CANNULA: 8.0 MM During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall 24FR FLEX ART CANN NON STERILE During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall SPECIALTYCARE - HUDGENS During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall CUSTOM CPB CATHETER KIT-DR During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall CPB CATHETER KIT- DR.VAN TRIGHT During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxic-ischemic encephalopathy (HIE) Olympic Cool-Cap Cooling Module’s power supply failed during treatment. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Dakota, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas and Washington named
- Medical device recall Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have… Potential for the sterility barrier to be compromised. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have… Potential for the sterility barrier to be compromised. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have… Potential for the sterility barrier to be compromised. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have… Potential for the sterility barrier to be compromised. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have… Potential for the sterility barrier to be compromised. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Medtronic 0-arm Imaging System with Software Version 3.1.1 Software Version 3.1.1 does not meet navigational accuracy. Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide, and Colorado, Indiana and Minnesota named
- Medical device recall Boston Scientific Profile Single-Use Pediatric Snare 11mm UPN Outer Box M00562531 Inner Pouch: M00562530 ,… Difficulty in extending snare loop from the catheter Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific Profile Single-Use Pediatric Snare 13mm UPN Outer Box: M00562551 Inner Pouch: M00562550 The… Difficulty in extending snare loop from the catheter Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Boston Scientific Profile Single-Use Pediatric Snare 27mm UPN Outer Box: M00562571 Inner Pouch: M00562570 The… Difficulty in extending snare loop from the catheter Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VerifyNow P2Y12 Assay The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used… The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow… Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall seprafilm¿ Procedure Pack ADHESION BARRIER Re-order Number: 5086-02 Product Usage: Seprafilm Adhesion Barrier… Sterility of product may be compromised due to packaging defect Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall seprafilm¿ Single Site ADHESION BARRIER Re-order Number: 6641-01 Product Usage: Seprafilm Adhesion Barrier is… Sterility of product may be compromised due to packaging defect Class IIFDA’s classJun 27, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sigma Spectrum VOLUMETRIC INFUSION PUMP, with or without Master Drug Library Recall expansion; the infusion pumps have the potential to fail causing inaccurate flow conditions during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 20, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 20, 2012ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Philips Healthcare Practix Convenio Mobile X-ray system Worldwide Distribution -- Nationwide When the system is switched off or when the tube arm is parked in the down position (X-ray generator switch off), a radiation pulse (50 kV, 2.5 pGy) is… Class IIFDA’s classJun 20, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare Revolution XR/d An incident was reported that an operator’s finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the… Class IIFDA’s classJun 20, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GE Healthcare Definium 8000 Digital Radiographic Systems : GE Healthcare, 3000 North Grandview , Waukesha,… An incident was reported that an operator’s finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the… Class IIFDA’s classJun 20, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GE Proteus XR/a Radiographic System An incident was reported that an operator’s finger was pinched between the fixed roller and the gliding tabletop of a Proteus XR/a Table while moving the… Class IIFDA’s classJun 20, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional… Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3,… Class IIFDA’s classJun 20, 2012in FDA’s Enforcement Report22 statesnamed in where it went PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereAlabama, California, District of Columbia, Delaware, Florida, Georgia, Iowa, Indiana, Massachusetts, Maryland, Minnesota, Mississippi, North Carolina, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Washington and West Virginia
- Medical device recall Lipofilter 3000 Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable to sterilize the device according to procedures. Class IIFDA’s classJun 20, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNationwide, and California, New York and Ohio named
- Medical device recall Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision… During an internal quality inspection, the tibia plateau was found to be out of specification. Class IIFDA’s classJun 20, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania and Texas named
- Medical device recall PlasmaJet Open Surgery Handpiece (Part of the PlasmaJet Neutral Plasma Surgery System) The PlasmaJet system… Potential failure in the glued seal between the stem and the tip of the handpiece leading to the possible leakage of a very small drop of distilled water… Class IIFDA’s classJun 20, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNationwide, and California and New York named
- Medical device recall Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type… The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for CE marked Mozaik Strip and Putty products contains an… Class IIFDA’s classJun 20, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Integra Mozaik Putty 2.5cc, 5 cc, 10 cc Product Usage: The product is a bone graft substitute composed of… The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l for CE marked Mozaik Strip and Putty products contains an… Class IIFDA’s classJun 20, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 20, 2012ClassClass IIStatusTerminatedWhereNo state 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.