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 Medfusion Syringe Pump 3010 Series The Medfusion¿ Syringe Infusion Pumps are indicated for the following… Certain Medfusion Syringe Pump Models, Series 3100, 3500, and 4000, may not recognize or may misidentify loaded medication syringes. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MyLab Ultrasound System The ultrasound system used in certain settings may result in overheating of the ultrasound probe head. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, Oklahoma, Pennsylvania and Texas
- Medical device recall MyLab Ultrasound System The ultrasound system used in certain settings may result in overheating of the ultrasound probe head. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, Oklahoma, Pennsylvania and Texas
- Medical device recall BD Vacutainer¿ EDTA Lavender Top Tubes BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 28, 2018in FDA’s Enforcement Report47 statesnamed in where it went PublishedMar 28, 2018ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, 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 and West Virginia
- Medical device recall BD Vacutainer¿ EDTA Tan Top Tube BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 28, 2018in FDA’s Enforcement Report47 statesnamed in where it went PublishedMar 28, 2018ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, 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 and West Virginia
- Medical device recall BD Vacutainer¿ EDTA Pink Top Tube BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 28, 2018in FDA’s Enforcement Report47 statesnamed in where it went PublishedMar 28, 2018ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, 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 and West Virginia
- Medical device recall BD Vacutainer¿ Lithium Heparin Green Top Tube BD Vacutainer EDTA Lavender, Tan, and Pink Top Tubes and BD Vacutainer Lithium Heparin Green Top Tubes can cause an underestimation of lead in blood samples… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 28, 2018in FDA’s Enforcement Report47 statesnamed in where it went PublishedMar 28, 2018ClassClass IStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, 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 and West Virginia
- Medical device recall Flex-Neck Classic Peritoneal Dialysis Catheter 1 Cuff Infant Coiled 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Custom Dialysis Kit CF-4235 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 1… 2 Cuff catheters were incorrectly configured and labeled as 1 Cuff product and placed into these dialysis kits. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Custom Dialysis Kit CF-4230 Without Gel, which includes Flex-Neck¿ Classic Peritoneal Dialysis Catheter 2… 1 Cuff catheters were incorrectly configured and labeled as 2 Cuff product and placed into these dialysis kits. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ClariVein IC infusion catheter Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 23 states named PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Missouri, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia and Washington named
- Medical device recall DERMABOND” PRINEO” Skin Closure System Product Usage: DERMABOND PRINEO System is intended for topical… Ethicon discovered that specific lots of DERMABOND”PRINEO”System may not dry within the specified time after proper application, and thus may fall off. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Artis one fluoroscopic x-ray system and patient table Artis one is an angiography system developed for… Certain patient table systems may have a missing or incorrectly installed snap ring that could cause the bolt to slide out of its base and the tabletop… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement Report13 statesnamed in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereAlabama, Arkansas, California, Florida, Indiana, Louisiana, Michigan, Missouri, North Carolina, New York, Pennsylvania, Texas and Washington
- Medical device recall Wash Kit (REF 10680) Lots 16279, 17045 and 17215 Medica corporation is marketing a wash solution Chemistry… The firm has initiated a field recall of the Wash1 Kit REF 10680 due to reported inconsistent Lipase values when analyzing patient samples. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AXIOM Artis angiographic x-ray system Certain systems may have leaking of the plastic coolant couplings, the liquid can enter into the flat panel detector leading to a failure of the detector. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement Report12 statesnamed in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereArizona, California, Florida, Iowa, Illinois, Louisiana, Michigan, North Carolina, New Jersey, Ohio, Oklahoma and Texas
- Medical device recall AutoMate 2550 “High Speed” A misaligned pipette tip sensor poses the remote risk of cross-contamination when failing to cause a no-tip error, resulting in pipetting patient samples… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARROWg+ard Blue PLUS catheter Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereFlorida
- Medical device recall J-Plasma Precise(R) OPEN Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall J-Plasma Precise(R) Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall J-Plasma(R) Handpiece Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall J-Plasma Precise 360(R) Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall J-Plasma Precise(R) FLEX Bovie Medical is issuing a correction to address incomplete insertion of the J-Plasma(R) handpiece cable plug into the generator receptacle resulting in an… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features and… Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety… Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Percutaneous Sheath Introducer Kit with ARROWg+ard Blue Sheath, Integral Hemostasis Valve/Side Port, Sharps… Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue… Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS… Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS… Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS… Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pressure Injectable Multi- Lumen CVC Kit Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SwishTapered Implant Intended for use in support for fixed bridgework. The extender that is packaged with the SwishTapered” and SwishPlus” Implant may have been packaged in the incorrect position (upside down in the plastic… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall SwishPlus Implant Intended for use in support for fixed bridgework. The extender that is packaged with the SwishTapered” and SwishPlus” Implant may have been packaged in the incorrect position (upside down in the plastic… Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall AutoMate 1200 Belts on the x-axis (and on the y-axis, to a lesser extent) manufactured from 2015 are showing premature failure, posing the remote risk of cross-contamination. Class IIFDA’s classMar 28, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 28, 2018ClassClass IIStatusCompletedWhereNo state named
- Medical device recall Vygon IV Start Convenience Kits The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Proteus 235, Uniform and Pencil Beam Scanning The Proton Therapy System - Proteus 235 (brand names: Proteus… An accessory (range shifter, ridge filter&) can be improperly inserted in snout 300x400 with one rail only and the proton therapy system can still operate. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereFlorida, Massachusetts, Oklahoma, Pennsylvania, Tennessee and Virginia
- Medical device recall Difco” Agar Noble, 500g bottle Noble Agar is a solidifying agent that is essentially free of impurities HighPuragar was mislabeled and inadvertently sold as Noble Agar. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Iowa, Illinois, Indiana, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Utah, Virginia and Washington named
- Medical device recall Argyle Suction Tubing (Product # 8888301515) Argyle Suction Tubing is an extruded tube used as an extension… Incorrect packaging. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Liquid Cardiac Control CQ5053 Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the… There is a risk of misalignment of the patient when using treatment plans with multiple isocenters. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Trabecular Metal¿ Primary Hip Prosthesis Two lots of hip implants are mislabeled. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereLouisiana and New York
- Medical device recall Accolade and Restoration hip product Inner and outer sterile barriers not fully sealed. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereArkansas, Delaware, Florida, Illinois, Indiana, Michigan, New Jersey, Ohio, Tennessee and Texas
- Medical device recall Accolade and Restoration hip product Inner and outer sterile barriers not fully sealed. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement Report10 statesnamed in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereArkansas, Delaware, Florida, Illinois, Indiana, Michigan, New Jersey, Ohio, Tennessee and Texas
- Medical device recall INFINITY DUAL HEMO MCable Pod Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dr¿ger Infinity Acute Care System, may permit liquid ingress inconsistent… Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand… The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNationwide, and Michigan named
- Medical device recall ReWalk Personal 6.0 Firm received complaints for ReWalk Personal 6.0 of an injury to tibia and fibula. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT 3M discovered that the Futuro” Quick Strap Ankle Brace (Cat. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ACE (TM) BRAND, DELUXE ANKLE BRACE, 207736 3M discovered that the Futuro” Quick Strap Ankle Brace (Cat. Class IIFDA’s classMar 21, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 21, 2018ClassClass 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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