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 6, 2026.
3,757of 3,757 medical device recallsshown with your filters
The list
- Medical device recall T-Plate, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Y-Plate, Sterile Firm is conducting a voluntary recall of the Rival Reduce Fracture Plating System and Rival View Plating System. Class IIFDA’s classJun 13, 2018in FDA’s Enforcement Report19 statesnamed in where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereCalifornia, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, North Carolina, New Jersey, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas and Virginia
- Medical device recall Heartware Medtronic HVAD System for cardiac use Possible transient electrical connection interruption between an HVAD System power source (Battery, AC Adapter, or DC Adapter) and the Controller, while the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IStatusOngoingWhereNationwide
- Medical device recall CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) Ingress of fluids into the device can affect various electronic circuit boards which would prevent initiation or continuation of therapy. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 6, 2018in FDA’s Enforcement Report50 statesnamed in where it went PublishedJun 6, 2018ClassClass IStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall MEDLINE Sterile* Needle Counter, 100Ct The product packaging seal has the potential to experience seal creep. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MEDLINE Sterile* Needle Counter, 40Ct The product packaging seal has the potential to experience seal creep. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MEDLINE Sterile* Needle Counter, 40Ct The product packaging seal has the potential to experience seal creep. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover,… The product packaging seal has the potential to experience seal creep. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover,… The product packaging seal has the potential to experience seal creep. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard… The product packaging seal has the potential to experience seal creep. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads… Potential keypad failure on VOLISTA StandOP Surgical Lights. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Disposable Drill Kit which includes two drill bits, two drill stops, and two adjustment wrenches, sterile There is a possibility that DDK2-2.4-30X Disposable Drill Kits, Lot Number 111664 208140649 contained 2.8mm drill bits from DDK2-2.8-30X Disposable Drill Kits,… Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, District of Columbia, Florida, Massachusetts, Michigan, North Carolina, New York, Washington and Wisconsin named
- Medical device recall SOMATOM go.Now, Material Number 11061618 There is a potential for a software issue that may cause the need… There is a potential for a software issue that may cause the need for necessary patient rescans. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Missouri, North Dakota, New York, Ohio, Oklahoma, South Dakota, Tennessee, Texas and Virginia named
- Medical device recall SOMATOM Go.Up, Material Number 11061628 There is a potential for a software issue that may cause the need for… There is a potential for a software issue that may cause the need for necessary patient rescans. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Missouri, North Dakota, New York, Ohio, Oklahoma, South Dakota, Tennessee, Texas and Virginia named
- Medical device recall Symmetry Olsen Monopolar Pencil: (a) Button Switchpen, w/ Standard Needle Electrode Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Symmetry Olsen bipolar cord: (a) Bipolar Cord, Twin Pin Connector to Shrouded Instrument Connector, 12’ Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Symmetry Olsen monopolar cord: (a) Monopolar Cord, 1/8” Diameter Pin, TUR Connector, 10’ Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Symmetry Olsen bipolar forceps: (a1) Insulated Irrigating Bayonet Forceps 6.25” Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Symmetry Olsen monopolar forceps: (a) Insulated Potts-Smith Forceps 8” Products may encroach into the sterile pouch seal thereby increasing the risk of the seal being compromised. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophylline Assay is a homogeneous enzyme… Lot J1 of the Syva¿ EMIT¿ 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry System, may exhibit increased imprecision for commercially… Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Respire Pink Series EF+ Oral Sleep Apnea Device. Potential for device breakage during use Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Respire Pink+ Hard/Soft Oral Sleep Apnea Device Potential for device breakage during use Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Respire Pink+ Hard Oral Sleep Apnea Device Potential for device breakage during use Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Respire Pink H/S Oral Sleep Apnea Device Potential for device breakage during use Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Respire Pink H/S Oral Sleep Apnea Device Potential for device breakage during use Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators There is a potential for the cord to spark and cause a fire. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedJun 6, 2018ClassClass 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, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Sternal Valve Retractors With Atrial and Aortic Rakes Failure in a retractor blade due to corrosion. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Carina Ventilator, ventilator The valve assembly material may become corroded due to insufficient cleaning by a supplier. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereConnecticut, Illinois, Minnesota, Nevada, South Dakota and Washington
- Medical device recall Dynarex CGA870 All Brass Oxygen Regulator, All Brass - 0-25 LPM, Barb & 2-DISS Outlet The device is equipped with a dial that has an inaccurate flow rate indicator. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereMassachusetts and New Jersey
- Medical device recall MagNA Pure 24 System, GMMI: 07290519001 Product Usage: The MagNA Pure 24 System is a fully automated clinical… Cross-contamination of samples has been reported when running the existing protocol on the system with the rack-based purification run. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Georgia, Hawaii, Indiana, Maryland, Maine, Michigan, Minnesota, North Carolina, New York, Pennsylvania, US Virgin Islands and Wisconsin named
- Medical device recall Catheter Hemostasis Valve For use with .038” (.096 cm) dia Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Continuous Nerve Block Needle Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Echogenic Introducer Needle Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Spring Wire Guide Introducer Needle Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Epidural Needle Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall SnapLock” Catheter/Syringe Adapter Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Maximal Barrier Drape Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Maximal Barrier Drape Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Maximal Barrier Drape Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Maximal Barrier Drape Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Maximal Barrier Drape Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Radial Arterial Access Kit Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Radial Artery Catheterization Kit Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Arterial Catheterization Kit Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Radial Artery Catheterization Kit with Sharps Safety Features Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Radial Artery Catheterization Kit with Sharps Safety Features Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features Product sterility may be compromised due to unsealed packaging. Class IIFDA’s classJun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 6, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico 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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