Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall Oxoid Legionella Latex Test, DR0800M, containing 50 tests per box A reagent within the test may return false negative results. Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, District of Columbia, Florida, Illinois, Maine, New Jersey, New York, Pennsylvania, Virginia and Vermont named
- Medical device recall Calcitonin ELISA Kit, Code No. 7024, 7024BU A potential issue with false high values. Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, New Hampshire and New Jersey
- Medical device recall The J700 Floor Mounted Tube Stand (FMTS) is intended to support and position the diagnostic x-ray tube… The welds on J700 tube stands may be insufficient resulting in tube stand breakage, damage to the X-Ray machine, and/or patient or healthcare provider injury. Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereArizona, Colorado, Illinois, Kentucky, Louisiana, Nebraska, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall LUNA Chest, Model No. LU4006 Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. Class IIIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedDec 3, 2014ClassClass IIIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Iowa, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Non-sterile drape Non sterile-drape LUNA drape was inadvertently mislabeled with an additional contents sterile label. Class IIIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedDec 3, 2014ClassClass IIIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Iowa, Idaho, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Cardiac Function Analysis Software Product Data No Potential problem with the cardiac function analysis software (CFA). Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Massachusetts and Maryland named
- Medical device recall Cardiac Function Analysis Software Product Data No Potential problem with the cardiac function analysis software (CFA). Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Massachusetts and Maryland named
- Medical device recall IntelliSpace Portal DX/HX/EX Software defect. Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereFlorida, North Carolina and Vermont
- Medical device recall ARCHITECT Total T3 Reagent Kit 17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower Relative Light Units (RLUs) than expected, which… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Dharma Cavity Varnish with Fluoride During an FDA inspection, it was found that the products are being marketed without a cleared 510k. Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Pennsylvania and Puerto Rico
- Medical device recall Dharma Cavity Varnish 15mL During an FDA inspection it was found that the products are marketed without a cleared 510k. Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Pennsylvania and Puerto Rico
- Medical device recall 7F NeuroFlo Catheter After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNorth Carolina
- Medical device recall Cannulaide, Model 101, 102, 103. Respirator. The Cannulaide product is composed of die-cut… Cannulaide recalled May 2008 due to improper seal of the pouch. Class IIFDA’s classDec 3, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Louisiana, Massachusetts, New Jersey and Oregon
- Medical device recall CooperSurgical LEEP RADIUS LOOP ELECTRODE (W 2.0 cm x D 1.0 cm D, 12 cm shaft ) Outer box is mislabeled as P/N R2010- Large Radius Loop Electrode instead of P/N R1010- Medium Radius Loop Electrode Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000 and Esprit/V200 Conversion… If the power supply fan mounting screws are installed incorrectly, the ends of the screws may touch the power supply printed circuit board assembly (PCBA) and… Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Instructions for Use for the blue endo MOREsolution Electromechanical Laparoscopic Morcellator System Some pages of the Instructions for Use were omitted, including pages regarding the Indications for Use, Warning, and Contraindications. Class IIFDA’s classDec 3, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 3, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur¿ and ADVIA Centaur¿ XP and ADVIA Centaur¿ CP Cleaning Solution (For in vitro diagnostic use… Stability of the ADVIA Centaur Cleaning Solution is not assured Class IIIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW There is a possibility the sterile packaging may fail before the expiration date specified on the package. Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Connecticut, Florida, Georgia, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall Transport Chair and Rollator Silver Star Brands is recalling the Transport Chair and Rollator in One because they have received several reports of the wheel assembly failing resulting in… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Louisiana, Maryland, Michigan, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Oklahoma and Pennsylvania named
- Medical device recall Edwards Lifesciences Vent Catheters Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet. Class IIFDA’s classNov 26, 2014in FDA’s Enforcement Report45 statesnamed in where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator Software upgrade to correct potential safety issue related to CyberKnife System that occurs when upgrading the Treatment Delivery Software for the first… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement Report26 statesnamed in where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Illinois, Indiana, Kansas, Massachusetts, Michigan, Missouri, Mississippi, North Carolina, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, Tennessee, Texas and Wisconsin
- Medical device recall 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable… The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. Class IIFDA’s classNov 26, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereAlaska, Florida, Ohio, Oklahoma and Texas
- Medical device recall LANX, REF, PCR8XXX-XXX Biomet Spine, LLC. Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Indiana, Louisiana and Texas named
- Medical device recall MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing… A problem can exist in MOSAIQ resulting in the display of incorrect numeric data due to a dose rounding error on printed reports. Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Colorado, Illinois, Maryland, Missouri, New York, Oklahoma, Oregon, Pennsylvania, Rhode Island, Texas and Virginia named
- Medical device recall MC-500 Multicolor Laser Photocoagulator using software version 2.20 Retrospective review found that a Engineering Change Order initiated in May 2013 for a memory function problem was not reported as required. Class IIFDA’s classNov 26, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Nebraska and New York
- Medical device recall Nidek Excimer Laser Corneal Surgery System Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement Report10 statesnamed in where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereArizona, California, Colorado, Connecticut, Florida, Louisiana, Maine, Michigan, Missouri and New York
- Medical device recall Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20 When the MC-500 is turned on and coagulation is performed without changing the laser color, the delivery unit occasionally fails to emit the laser, or the… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement Report11 statesnamed in where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Illinois, Indiana, Michigan, Minnesota, New Jersey, New York, Ohio, South Carolina, Texas and Utah
- Medical device recall The MectaLIF Oblique Handle The MectaLIF Oblique Handle has the laser marking "MEDIAL" on the incorrect side and could result in incorrect insertion of the device during surgery. Class IIFDA’s classNov 26, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado and Idaho
- Medical device recall SideFire Directional Laser Probe Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. Class IIFDA’s classNov 26, 2014in FDA’s Enforcement Report12 statesnamed in where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Kansas, Minnesota, Missouri, North Carolina, Ohio, Pennsylvania, Texas and Virginia
- Medical device recall FullFire Diffusing Tip Laser Probe Monteris Medical received a complaint of a separation of the distal sapphire tip from the laser delivery probe. Class IIFDA’s classNov 26, 2014in FDA’s Enforcement Report12 statesnamed in where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Connecticut, Florida, Georgia, Kansas, Minnesota, Missouri, North Carolina, Ohio, Pennsylvania, Texas and Virginia
- Medical device recall ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natriuretic… Siemens Healthcare Diagnostics has confirmed that approximately 2000 ReadyPacks from the ADVIA Centaur¿ Systems BNP reagent contains an ADVIA Centaur Systems… Class IIIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 26, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Etest¿ Ceftaroline (CPT32) WW B30 The products have a wrong expiration date on their labeling, 5 years instead of 2 years. Class IIIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedNov 26, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Etest¿ Ceftaroline (CPT32) WWB100 The products have a wrong expiration date on their labeling, 5 years instead of 2 years. Class IIIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedNov 26, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Etest¿ Ceftaroline (CPT32) US B30 The products have a wrong expiration date on their labeling, 5 years instead of 2 years. Class IIIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedNov 26, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Etest¿ Ceftaroline (CPT32) US B100 The products have a wrong expiration date on their labeling, 5 years instead of 2 years. Class IIIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedNov 26, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Etest¿ Ceftaroline (CPT32) US B30 The products have a wrong expiration date on their labeling, 5 years instead of 2 years. Class IIIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 30 states named PublishedNov 26, 2014ClassClass IIIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Iowa, Indiana, Kentucky, Massachusetts, Maryland, Michigan, Missouri, North Carolina, Nebraska, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of… Siemens became aware of a very rare occurrence where an intended movement of the SimView NT simulation system components could not be stopped with usual hand… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Kentucky, Louisiana, Massachusetts, Michigan and Pennsylvania named
- Medical device recall MediChoice Dual-Release Folding Walker with 5” wheel Product wheels may be too loose, too tight, or fall off. Class IIFDA’s classNov 26, 2014in FDA’s Enforcement Report23 statesnamed in where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Connecticut, Georgia, Illinois, Massachusetts, Maryland, Maine, Michigan, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oregon, Pennsylvania, South Carolina, Texas, Utah, Virginia, Vermont, Washington and Wyoming
- Medical device recall BAG 9732315 MOUSE STERILE 15 PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOPSY NEEDLE KIT, 9733068, PASSIVE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIT 9733516 2.9mm DRILL STERILE Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DISP 9730950 STRL SPHERE, 1 PK INSERT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DISP 9730951 STRL SPHERE, 5PK INSERT Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DRAPE 9732722 TUBE STERILE O-ARM 20PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ENT PRGM 9734636 ADD FUSION NAV AxiEM Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INST 9731132 KIT CR Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall INSTRUMENT TRACKER 9733533XOM ENT 1PK Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall KIT, 9731427, THORACIC TACTILE PROBES Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused… Class IIFDA’s classNov 26, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 26, 2014ClassClass IIStatusTerminatedWhereNationwide
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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