Medical devices, 2018
Shortlist up to four to read them side by side.
3,757 medical device recalls FDA’s Enforcement Report published in 2018, 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 7, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall Hex Driver Part Number HXDRIVER-2.0 AO; Hex Driver Part Number HXDRIVR-2.5 AO; Hex Driver Part Number… Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft… Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Phadia Prime software, article number 12-4101-00, as used in combination with the Phadia 250 Instrument,… We want to inform all Phadia 250 system operators performing EliA Assays not to use the function OK to All in any version of Phadia Prime, up to and including… Class IIFDA’s classApr 11, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereCalifornia, Georgia, Indiana, Massachusetts, Maine, Mississippi, North Carolina, New Jersey, Oregon, Tennessee, Texas, Utah and Virginia
- Medical device recall CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and… The transmitting stylet within CORTRAK* 2 nasogastric/Nasointestinal (NG/NI) Feeding Tubes with ANTI-IV* connector (Product Code 20-9551Trak2A) may be visible… Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Colorado, Georgia, Iowa, Louisiana, Michigan, Minnesota, New Mexico and Texas named
- Medical device recall 2008 K2 Hemodialysis Machine with software version 5.40, Models When the recirculation ultrafiltration (UF) Goal is set to a value greater than 200ml in service mode and the user starts a treatment using the SLED (Sustained… Class IIFDA’s classApr 11, 2018in FDA’s Enforcement Report16 statesnamed in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Florida, Georgia, Illinois, Massachusetts, Maryland, Minnesota, North Carolina, New York, Ohio, Pennsylvania, South Carolina, Tennessee and Texas
- Medical device recall Oncomine Dx Target Test User Guides and Assay Definition File The Oncomine Dx Target Test may report erroneous results when used off-label for samples other than non-small cell lung cancer (NSCLC) tumor specimens. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereArizona, California, North Carolina, Texas and Virginia
- Medical device recall Prismaflex Control Unit Firm has received reports of device operators failing to adhere to instructions for use pertaining to the safe unloading of disposable sets from the Prismaflex… Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Radial Artery Catheterization Kit The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month… Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Radial Artery Catheterization Kit The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month… Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Radial Artery Catheterization Kit The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month… Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Radial Artery Catheterization Kit The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month… Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Radial Artery Catheterization Kit The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month… Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Radial Artery Catheterization Kit The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month… Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Arterial Access Tray, introducer catheter The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month… Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Southmedic Oxygen Masks with EtCO2 sampling line Potential for loose or missing CO2 diffusers which could result in a non-functioning mask. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall DynaCad software consist of an MR Analysis Server software and the viewer workstation software Following update from 3.3 to 3.5 of the DynaCAD software it was noted that the Ktrans map was not rendered correctly on the DynaCad Client. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DS Titanium Ligation Clip, used in laparoscopic surgery Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall DS Titanium Ligation Clip Appliers, used in laparoscopic surgery Added a contraindication to IFU: Do not use the DS clips for living donor nephrectomies. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Uterine Electromyographic Monitor - Monica Novii Wireless Patch System Product Usage: The Novii Interface is… if the cables of the Monica Novii System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR)… Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Uterine Electromyographic Monitor -Monica IF24 Interface System Product Usage: The Monica IF24 CTG Interface… if the cables of the Monica IF24 System are removed by a user, and then incorrectly re-connected the Fetal Heart Rate (FHR) and Maternal Heart Rate (MHR)… Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Alpha Air 6 ENT Microscope Microscope examination of the human ear, nose, and throat. The microscope may tip over if attachments are fully extended in one line and there is an attempt to move the device not by the handles mounted on the post. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 11, 2018ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Illinois, Minnesota, Nevada, Oklahoma and Texas
- Medical device recall LeadCare II Blood Lead Analyzer The incorrect placement of AA batteries into certain LeadCare II Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could burn… Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall LeadCare Plus Blood Lead Analyzer The incorrect placement of AA batteries into certain LeadCare Plus Blood Lead Analyzer may cause the batteries to overheat, and the chance that a user could… Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Large Volume Abdominal Paracentesis Kit Product packaging may not be completely sealed. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ArrowClarke” PleuraSeal¿ Thoracentesis Kit Product packaging may not be completely sealed. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Pneumothorax Kit Product packaging may not be completely sealed. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Confidence Plus Kit Spinal Cement System Certain lots of the spinal cement may contain incorrect amounts of contrast medium so that the product is difficult or impossible to visualize on x-ray. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Binding Site Optilite Beta-2-Microglobulin Urine Kit The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall GE Healthcare Centricity PACS-IW A database handling error could occur during the image acquisition process affecting the completeness of acquired images with Centricity PACS-IW. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Syngo.via. Medical Device Software. Picture archiving and communications system. A software functionality in the report sections Findings Information and Summary of Measured Findings is not performing properly. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Dynavox T10 Speech Generating Device ( including Batteries) The battery is integral to the device. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Dynavox T15 Speech Generating Device ( including Batteries) The battery is integral to the device. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall A.L.P.S. MIS Calcaneus Locking Plate LG RT F.A.S.T. Guide inserts, Item Number: 816209003,UDI:… The drill guides were manufactured with the incorrect color anodization. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement Report8 statesnamed in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereArizona, Missouri, Montana, New Jersey, New York, Ohio, Texas and Washington
- Medical device recall HydroSil Gripper Intermittent Catheters- 10” lengths - 30 catheters per box, each catheter is Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Personal Intermittent Catheters- 16” and 10” lengths - 30 catheters per box, each catheter is Several instances of a catheter caught in the sterile barrier seal and in some instances cut catheters were observed. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 37 states named PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Iowa, Idaho, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Elecsys BRAHMS PCT Immunoassay for the in vitro quantitative determination of PCT (procalcitonin) in human… Product exhibits a decreased recovery of patient samples on the cobas e 801 module compared to the MODULAR ANALYTICS E 170, cobas e 411, 601, and 602 analyzers. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereCalifornia, Florida and Indiana
- Medical device recall ImmunoCAP Allergen c5, Ampicilloyl (article number 14-4450-01) The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ImmunoCAP Allergen c6, Amoxicilloyl ( Article number 14-4451-016) The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met. Class IIFDA’s classApr 11, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 11, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Proclaim DRG Implantable Pulse Generator The firm received complaints of error messages that occurred during routine impedance checks on Proclaim DRG IPGs, model 3664. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall HEMASHIELD Knitted Double Velour Cardiovascular Fabric A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall Zimmer Biomet Comprehensive Segmental Revision System (SRS) During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Universal/Anderson Connector, REF/Catalog Number 2602… Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H… Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Philips Plug Style Connector, REF/Catalog Number 2602H… Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, Physio-Control¿ Quik-Combo” Connector, REF/Catalog Number… Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MINI INFANT < 3KG, RADIOTRANSLUCENT ELECTRODE, ZOLL¿ Connector, REF/Catalog Number 2602Z Indicated for use in… Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall STAGE-1¿ RDS COC Abutment Plastic Sleeve, Non-Lock, Multi-Unit A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a… Class IIIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 4, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall BD Vacutainer¿ Barricor” Lithium Heparin Plasma Blood Collection Tubes for Invitro Diagnostic Use Increased amount of residual blood present on the top of stopper well after venipuncture Class IIFDA’s classApr 4, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 4, 2018ClassClass 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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