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 5, 2026.
1,310of 1,310 medical device recallsshown with your filters
The list
- Medical device recall Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications. Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit Duet TRS may have the potential to injure adjacent anatomical structures which may result in life threatening post-operative complications. Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BP7561 OPTI CCA-TS B-Lac Cassette The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters). Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Idaho, Texas and Utah named
- Medical device recall Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable… On 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter… On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is… Terumo Cardiovascular Systems (CVS) received two reports of the false back flow alarms for the Terumo¿ Advanced Perfusion System 1 when there was no tubing in… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10) This notice concerns behavior of the SharePlan that may be unexpected and not clearly described in the user manual. Class IIFDA’s classOct 3, 2012in FDA’s Enforcement Report8 statesnamed in where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereCalifornia, Kentucky, Michigan, New York, Oklahoma, Oregon, South Dakota and Wisconsin
- Medical device recall Trinity Biotech, Captia VZV IgG The Positive Control for the Captia Varicella-Zoster Virus (VZV) IgG Kit has been reported as running high out of its assigned ISR range. Class IIIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedOct 3, 2012ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, California, Illinois, Indiana, Massachusetts, Maryland, New Jersey, Ohio, Pennsylvania, Puerto Rico, Tennessee and Texas named
- Medical device recall Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX) Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biliary Catheters (Models A47XX and CB0XXXXX) Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Irrigation Catheters (Models IRR-XXX-XX) Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for… Terumo Cardiovascular Systems (CVS) received one report of a flow module for the Terumo Advanced Perfusion System 1 not displaying blood flow information on… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Armada 35/ Armada 35 LL PTA Catheters Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement Report19 statesnamed in where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Kentucky, Michigan, Mississippi, New Jersey, New Mexico, Nevada, New York, Ohio, Texas, Washington and Wisconsin
- Medical device recall Hologic Fluoroscan Mini C-Arm InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hologic Fluoroscan Mini C-Arm Fluoroscan Mini C-Arm models -InSight2, version 4.0 and 4.0.1 - DICOM images stored in PACS may be flipped 180¿around vertical axis. Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Progel Pleural Air Leak Sealant Product was distributed with an incorrect expiration date. Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source Linvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon Universal Light Source and LS7600 Xenon Light Source are… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel… An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were packaged as a Right Horseshoe Gel Pads and vice… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, District of Columbia, Georgia, Iowa, Illinois, Indiana, North Carolina and New York named
- Medical device recall The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel… An investigation of customer complaints identified that for two product lots, Left Horseshoe Gel Pads were packaged as a Right Horseshoe Gel Pads and vice… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, District of Columbia, Georgia, Iowa, Illinois, Indiana, North Carolina and New York named
- Medical device recall Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall Alere Triage TOX Drug Screen 9 Panel, P/N: 94402 Alere San Diego is recalling Alere Triage TOX Drug Screen because there is a possibility that after installing the code chip provided with the affected lots:… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Invacare¿ I-Fit” Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035 On August 6, 2012, Invacare voluntarily recalled the Invacare¿ I-Fit” Shower Chair (Models 9780, 9781, 9781-1) based on the return, quality and adverse event… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedOct 3, 2012ClassClass 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Varian brand Eclipse Treatment Planning System Varian has identified an anomaly with the Eclipse Treatment Planning where an outdated assigned Hounsfield Unit [HU] value can be used for dose calculation… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DEXIS Imaging Suite A condition can occur during renumbering of the patient database using the DEXCopy feature. Class IIFDA’s classOct 3, 2012in FDA’s Enforcement Report42 statesnamed in where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, 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 and Wisconsin
- Medical device recall Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and… When positioning the Flex Large 4 Coil (part No. Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release… The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large… KCI has issued a medical device correction for the BariAir Therapy System Hand Pendent. Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KY LIQUIBEADS Vaginal Moisturizer Johnson & Johnson Healthcare Products (JJHP) is voluntarily recalling this product to address FDA concerns that the product should have been cleared under a… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TSX-301A/2 Aquilion One CT System The SureStart function may not operate in the usual manner, and you may obtain abnormal analysis results when using the cerebral blood flow analysis function. Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts, Maryland and Nevada named
- Medical device recall Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy… ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)because there is a possibility that the product may have a… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 33 states named PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar… This medical device correction is related to Alcon products that present a 23G non-valved trocar cannula and infusion cannula together because of an issue… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall UltraFlow HPC Flow Directed Micro Catheter The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Minnesota, Oregon and Texas named
- Medical device recall Marathon Flow Directed Micro Catheter The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters… Class IIFDA’s classOct 3, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedOct 3, 2012ClassClass IIStatusTerminatedWhereNationwide, and Florida, Minnesota, Oregon and Texas named
- Medical device recall CMS-4501-R1 Custom HSG Tray containing 2 oz The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing in place at the manufacturer and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 26, 2012ClassClass IStatusTerminatedWhereNationwide, and Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey and Pennsylvania named
- Medical device recall CMS-8457 Hysteroscopic Sterilization Pack containing 4 oz The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 26, 2012ClassClass IStatusTerminatedWhereNationwide, and Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey and Pennsylvania named
- Medical device recall CMS-4316 Custom Vein Tray containing 4 oz The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 26, 2012ClassClass IStatusTerminatedWhereNationwide, and Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey and Pennsylvania named
- Medical device recall CMS-8450-R1 Custom Vein Tray containing 4 oz The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 26, 2012ClassClass IStatusTerminatedWhereNationwide, and Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey and Pennsylvania named
- Medical device recall CMS-2586 Custom Amnio Tray containing 2 oz The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 26, 2012ClassClass IStatusTerminatedWhereNationwide, and Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey and Pennsylvania named
- Medical device recall CMS-8162-R1 Fox Chase Specials Pack containing 2 oz The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 26, 2012ClassClass IStatusTerminatedWhereNationwide, and Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey and Pennsylvania named
- Medical device recall CMS-8325-R2 Abington Radiology Drainage Pack and CMS-8325-R3 Abington Radiology Drainage Pack containing 4 oz The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 26, 2012ClassClass IStatusTerminatedWhereNationwide, and Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey and Pennsylvania named
- Medical device recall CMS-8495-R5 Custom Vein Tray containing 4 oz The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 26, 2012ClassClass IStatusTerminatedWhereNationwide, and Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey and Pennsylvania named
- Medical device recall CMS-4873 Custom CT Biopsy Tray, CMS-4873-R1 Custom CT Biopsy Tray containing 4 oz The firm saw on the FDA web site a recall by the manufacturer of the Povidone Iodine Prep Solution due to no microbial testing and product did not meet proper… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 26, 2012in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedSep 26, 2012ClassClass IStatusTerminatedWhereNationwide, and Colorado, Florida, Kansas, Massachusetts, Michigan, New Jersey 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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