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 5, 2026.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall ADULT Radiotransparent Electrode Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 31, 2014ClassClass IStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Dakota, Nebraska, New Mexico, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall ADULT/CHILD Radiotransparent Electrode Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 31, 2014ClassClass IStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Dakota, Nebraska, New Mexico, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall ADULT Radiotranslucent Electrode Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 31, 2014ClassClass IStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Dakota, Nebraska, New Mexico, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall ADULT Radiotranslucent Electrode Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 31, 2014ClassClass IStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Dakota, Nebraska, New Mexico, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall ADULT/CHILD Radiotranslucent Electrode Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 31, 2014ClassClass IStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Delaware, Florida, Georgia, Illinois, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, North Dakota, Nebraska, New Mexico, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas, Virginia, Vermont and Washington named
- Medical device recall GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electrodes The firm discovered that during the use of these defibrillation electrodes a possibility for arcing and a resulting malfunction exists. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 31, 2014ClassClass IStatusTerminatedWhereNationwide, and Ohio and Texas named
- Medical device recall HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data GE Healthcare has become aware of a potential data loss issue associated with empty path names resulting from HL-7 updates when the cache disk is almost full. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, Ohio and Washington named
- Medical device recall Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Si… The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Fluorescence Imaging Procedure Kit, designed for use with Firefly Fluorescence Imaging for the da Vinci Xi… The storage conditions for indocyanine green (ICG) are not on the individual Fluorescence Imaging Procedure Kit box, the six-kit box, and the shipping box. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall adaPT insight Two issues were identified: 1. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedDec 31, 2014ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall DPM 6 Patient Monitor and DPM 7 Patient Monitor Mindray has identified an issue that involves the IBP module used with the DPM 6 and DPM 7 Monitor where the IBP measurement data may be displayed in an… Class IIFDA’s classDec 31, 2014in FDA’s Enforcement Report23 statesnamed in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Missouri, Mississippi, Montana, North Carolina, North Dakota, New York, Ohio, Pennsylvania, South Carolina, Texas, Virginia, Washington and West Virginia
- Medical device recall Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in vitro… Customer complaints of discrepant flagged and/or un-flagged patient and QC results. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Neodent Titamax WS Cortical Implant ¿4.0 x 5 mm (Endosseous dental implant) Article Number: 109.604 Dental… Product not approved for use in the US Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Massachusetts and New York named
- Medical device recall STERRAD 50, Product Code 10114. The STERRAD Cassettes are used on STERRAD Sterilization System which is a low… Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not… Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall STERRAD 100S Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not… Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall STERRAD 200, Product Code 10118 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low… Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not… Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall STERRAD NX, Product Code 10133 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low… Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not… Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall STERRAD 100NX Advanced Sterilization Products is recalling the STERRAD System cassettes because the the leak indicator on the STERRAD System cassettes packaging may not… Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Replacement LED PCB Kit Replacement LED Board kit of Natus neoBLUE2 Phototherapy system distributed after February 16, 2012 is subject of a Field Safety Notification because the… Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall VITROS CHEMISTRY PRODUCTS TRIG Slides Potential for biased results using the specific lot of VITROS CHEMISTRY PRODUCTS TRIG slides. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Illumina MiSeqDx Universal Kit 1.0, PN 15039608 The Illumina MiSeqDx Universal Kit 1.0 is a set of reagents… It was discovered a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Universal Kit 1.0 on the MiSeqDx instrument. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement Report5 statesnamed in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereArizona, California, Georgia, Ohio and Virginia
- Medical device recall Illumina MiSeqDx Cystic Fibrosis Clinical Sequencing Assay in vitro diagnostic system for use on the Illumina… Illumina has confirmed a software limitation with MiSeq Reporter software (version 2.2.31) when using the MiSeqDx Cystic Fibrosis Clinical Sequencing Assay on… Class IIIFDA’s classDec 31, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 31, 2014ClassClass IIIStatusTerminatedWhereMaryland and New York
- Medical device recall NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green /… During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS 300/350 Control Series with… Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the washer and disinfector of Getinge 46-Series (CM302) with PACS… Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Persona Cemented Tibial Broach Inserter/Extractor The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement Report12 statesnamed in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Illinois, Michigan, Minnesota, North Carolina, New Jersey, Ohio, Oregon and Pennsylvania
- Medical device recall UniStrip1, Blood Glucose Test Strips, 50 count box Failure to submit a 510(k) for device labeling changes. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement Report2 statesnamed in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereFlorida and Ohio
- Medical device recall Lite DM (Lite Data Manager) Software Version(s): Versions 2.0.0.19 and lower Product HORIBA Medical is informing all HORIBA Medical Lite DM customers using software version 2.0.0.19 and lower of a software bug related to the potential for… Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RTH8 Rotor, P/N X01-005847-001 Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifuge because the RTH8 rotor may develop cracks with use over… Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Cyberonics VNS Therapy AspireHC The recalled product was distributed with an incorrect serial number printed on the device’s label. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedDec 31, 2014ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic tests. A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in vitro… A slight crack of the tubing at the connecting fitting on the reservoir connector assembly may occur due to mechanical stress. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall UroSeal Adjustable Endoscopic Valve Packaging non-conformance related to the integrity of the sterile pouch seal. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereFlorida, Missouri, Ohio and Wisconsin
- Medical device recall Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated… A software anomaly was identified where the system may automatically transition from “Standby” to “Ready to Fire” state while in surgical use. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement Report21 statesnamed in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, Mississippi, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, Texas, Wisconsin and West Virginia
- Medical device recall Bausch & Lomb Stellaris PC w/ Laser Upgrade BL1433 (Stellaris PC w v3 Software) with BL2272 (Laser Upgrade… A software anomaly was identified where the system may automatically transition from “Standby” to “Ready to Fire” state while in surgical use. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement Report21 statesnamed in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, Mississippi, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, Texas, Wisconsin and West Virginia
- Medical device recall Bausch & Lomb Stellaris PC w/ Laser Upgrade BL14334 (Stellaris PC w v4 Software) with BL2272 (Laser Upgrade… A software anomaly was identified where the system may automatically transition from “Standby” to “Ready to Fire” state while in surgical use. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement Report21 statesnamed in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, Mississippi, New Hampshire, New York, Ohio, Oklahoma, Pennsylvania, Texas, Wisconsin and West Virginia
- Medical device recall KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.0 mm The cuff inflation line may detach from the endotracheal tube during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 31, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Missouri, Mississippi, Montana, North Dakota, New Hampshire, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Utah, Virginia and West Virginia named
- Medical device recall KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 7.5 mm The cuff inflation line may detach from the endotracheal tube during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 31, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Missouri, Mississippi, Montana, North Dakota, New Hampshire, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Utah, Virginia and West Virginia named
- Medical device recall KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 mm The cuff inflation line may detach from the endotracheal tube during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 31, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Missouri, Mississippi, Montana, North Dakota, New Hampshire, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Utah, Virginia and West Virginia named
- Medical device recall KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.5 mm The cuff inflation line may detach from the endotracheal tube during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 31, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Missouri, Mississippi, Montana, North Dakota, New Hampshire, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Utah, Virginia and West Virginia named
- Medical device recall KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm The cuff inflation line may detach from the endotracheal tube during use. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 26 states named PublishedDec 31, 2014ClassClass IStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Indiana, Kansas, Kentucky, Massachusetts, Maine, Michigan, Missouri, Mississippi, Montana, North Dakota, New Hampshire, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Utah, Virginia and West Virginia named
- Medical device recall Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating Maquet has confirmed through a customer complaint that while the oxygenators and the pouches for a single lot of Quadrox-ID Pediatric Diffusion Membrane… Class IIFDA’s classDec 31, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereDistrict of Columbia, Massachusetts and Michigan
- Medical device recall Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare… Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because they were distributed prior to closure of the validation. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereIllinois, Texas and Utah
- Medical device recall Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator The firm has found that the Component- Dianz Capacitor has ruptured which results in a potential fire hazard. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the… Batches of HemoCue Glucose 201 Microcuvettes show discoloration and provide results outside the specification at the end of their shelf life, approx. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Solitaire-C Cervical Spacer System a) 14-531593 Drill/Awl Sleeve b) 14-531594 Spring-Loaded Drill/Awl Sleeve… A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments ( the Sleeves ) allow the mating Drill and Awl… Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular System is indicated for either… Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell would not attach to the inserter/impactor instrumentation. Class IIFDA’s classDec 31, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 31, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Brilliance iCT Computed Tomography X-Ray System Product Usage: The Brilliance iCT/Brilliance iCT SP… It was discovered that a software defect may result in the scanner not terminating the CT scan at the intended location. Class IIFDA’s classDec 24, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 24, 2014ClassClass 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.”
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