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 Synthes Flexible Medullary Reamer Due to the coiled design for this product, the product is difficult to clean and the potential for corrosion on the device exists. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall REF 00-4309-071-36 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 36 mm… There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall REF 00-4309-071-40 Trabecular Metal Reverse Shoulder System Instrumentation, Glenosphere Helmet, 40 mm… There is potential for one or both tabsof theTrabecular Metal Reverse Glenosphere Helmet to fracture during use and become disassociated from the device. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall StealthStation S7 Framelink Software version 5.4 Medtronic Navigation, Inc. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Invue Solid Driver, Tipped, AO The nipple of the tipped driver broke off when surgeons were attempting to insert the screw. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereDistrict of Columbia, Massachusetts and Oklahoma
- Medical device recall Case Lid and Base (Inspan, Invue, SLIFT) Caddy Lid (Inspan, Arena-C) Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement Report4 statesnamed in where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereFlorida, Massachusetts, Ohio and Texas
- Medical device recall Disposable Temperature Probes, (sterile), Sensor diameter: 3mm/0.12 in GE Healthcare has become aware of a potential safety issue associated with the use of GE General Purpose 9 French Temperature Probe, Disposable, 400 Series… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biomet 3i Dental Implant, Parallel Walled 6mm (D) x 10mm (L) A small number of outer implant boxes may be mislabeled. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall Biomet 3i Dental Implant, Non-Platform Switched Parallel Walled Implant 5mm (D) x 13mm (L) A small number of outer implant boxes may be mislabeled. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereMassachusetts
- Medical device recall Remel X/pect Flu A&B Control Swabs, For In Vitro Diagnostic Use Flu A+ Control Swabs incorrectly give Flu A- results when used for quality control testing with the Xpect Flu A&B test kit. Class IIIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 21, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Kansas, Massachusetts, Maryland, Michigan, Missouri, New Mexico, Nevada, New York, Ohio, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall Edwards Lifesciences Anastaflo Intravascular Shunt Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessive adhesive on the shunt body that may interfere… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Arrow International, Inc Arrow is recalling the product due to a labeling inconsistency. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement Report10 statesnamed in where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereAlabama, Arizona, Connecticut, Illinois, Kansas, North Carolina, New Jersey, Pennsylvania, Rhode Island and Virginia
- Medical device recall Medtronic Affinity Pediatric Arterial Filter Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereIllinois and Mississippi
- Medical device recall Terumo¿ Advanced Perfusion System 1: 100/120V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion… The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Terumo¿ Advanced Perfusion System 1: 220/240V AC, Advanced Perfusion System 1 The Terumo¿ Advanced Perfusion… The operators manual does not fully describe the sequence of expected events that will occur when a specific operating condition exists. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ADVIA Centaur Calibrator A Calibrator A lot CA77 is under-recovering to the assigned target for the ADVIA Centaur Total T4 Assay. Class IIIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedAug 21, 2013ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Vermont and West Virginia named
- Medical device recall epoc BGEM Test Card (Catalogue number CT-1004-00-00) This recall is being initiated because the affected lots of this product may yield results that are not consistent with stated precision performance criteria… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, US Virgin Islands, Washington, Wisconsin and West Virginia named
- Medical device recall Edwards EndoReturn Arterial Cannula Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Virginia named
- Medical device recall Terumo¿ Advanced Perfusion System 1 (APS1, System 1) 100/120V AC Product Usage: The Terumo¿ Advanced… Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump ‘Service Pump’ message may occur due to user… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Terumo¿ Advanced Perfusion System 1 (APS1, System 1) Description: 220/240V AC Product Usage: The Terumo¿… Terumo Cardiovascular Systems (TCVS) has become aware that an Advanced Perfusion System 1 (APS1) Centrifugal Pump ‘Service Pump’ message may occur due to user… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Siemens syngo.plaza SW version VA20 with Mammography license Siemens issued a Customer Safety Notice to inform customers of a potential problem when using syngo.plaza. Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Florida, Kansas, Massachusetts, New York, Ohio, Pennsylvania, Texas and Wisconsin named
- Medical device recall 100/120V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated… TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall 220/240V AC, Advanced Perfusion System 1 Product Usage: The Terumo¿ Advanced Perfusion System 1 is indicated… TCVS is taking action to update the Operators Manual with the specific instructions to respond to this condition and will issue a labeling addendum for current… Class IIFDA’s classAug 21, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedAug 21, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Enterprise 8000 Bed ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing… Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Enterprise 9000 Bed ArjoHuntleigh has received reports of unintended movement where the backrest and/or thigh sections of the bed have moved without anyone consciously pressing… Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall VENTANA (a member of the Roche Group) BenchMark ULTRA Potiential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the… Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VENTANA (a member of the Roche Group) DISCOVERY ULTRA Potential for a waste fluid overflow condition to accur while running decontamination cycles on the BenchMark ULTRA automated staining platform or the… Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alaris PC unit CareFusion is recalling the Alaris PC units model 8015 (PC unit), version 9.12, because it is operating at an incorrect voltage and it could potentially… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide
- Medical device recall List No. 14200-28 It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall List No. 14203-28 It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall List No. 14206-28 It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall List No. 14207-28 It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall List No. 14210-28 It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall List No. 14211-28 It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall List No. 14212-28 It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall List No. 14217-28 It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall List No. 14219-28 It was discovered that there was a potential for the piercing pin on certain Hospira blood sets to puncture the outer wall of blood bags during insertion of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Drill Guide - Chameleon FacetFuse Fixation System Prior to use in surgery, the Drill Guides were presenting noticeable degrees of denting and/or bending. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereColorado, Kansas, Massachusetts, Puerto Rico and Texas
- Medical device recall Non-sterile Viscot Surgical Skin Markers PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Markers, becuase they were inadvertently mislabeled as PN… Class IIFDA’s classAug 14, 2013in FDA’s Enforcement Report5 statesnamed in where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereOklahoma, South Carolina, Tennessee, Texas and Washington
- Medical device recall Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers Beckman Coulter is recalling the AU8500 Clinical Chemistry Analyzer because there is no labeling on the diluted detergent tank to show the proper disposition… Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall MRidium 1145 Dose Reduction System (DERS) drug library kit. (This is an option for the MRidium 3860+MR… The Dose Error Reduction System (DERS) can indicate an incorrect recommended value for the rate via a specific key sequence during the initial infusion setup. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedAug 14, 2013ClassClass IStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Mobiletta Mira Mobile X-ray System Siemens issued a Field Safety Alert about the potential risk to users when operating the Mobilett Mira. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement Report13 statesnamed in where it went PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereArkansas, Georgia, Iowa, Idaho, Illinois, Kansas, Michigan, North Carolina, Nebraska, Ohio, South Dakota, Texas and Wisconsin
- Medical device recall Medtronic Mullins Transseptal Adult 7F Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as… Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Arizona, California, District of Columbia, Delaware, Georgia, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, North Carolina, Nevada, New York, Ohio, Pennsylvania, Tennessee and Texas named
- Medical device recall Sonopet Ultrasonic Aspirator Console (Console 110V with Pedal & Pole) Product Usage: The Sonopet Console is… A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Hawaii, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall Sonopet Ultrasonic Aspirator Console 5450-851-000(Console 100V) Product Usage: The Sonopet Console is… A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Hawaii, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall Sonopet Ultrasonic Aspirator Console 5450-852-000 (Console 230V) Product Usage: The Sonopet Console is… A supplied component exhibiting corrosion was built into the power supply boards of the Sonopet Consoles listed above. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 14, 2013ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Florida, Hawaii, Iowa, Illinois, Kansas, Kentucky, Louisiana, Maryland, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Texas and Virginia named
- Medical device recall ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests A rare variant of TSH, identified in a small cluster of patients, is not detected. Class IIFDA’s classAug 14, 2013in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 14, 2013ClassClass 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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