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 AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Florida, New Hampshire and Ohio
- Medical device recall Cortisol Saliva Luminescence Immunoassay The IBL International Cortisol Saliva Luminescence immunoassay is… Product is not meeting specification for traceability to NIST cortisol standard, generating 1.3-1.8 times higher cortisol values with laboratory samples in… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report9 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereGeorgia, Iowa, Louisiana, Massachusetts, Minnesota, Oregon, Pennsylvania, South Carolina and Utah
- Medical device recall Stryker Mako Vizadisc Knee Procedure Tracking Kit Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report35 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Idaho, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Stryker Mako Vizadisc Hip Procedure Tracking Kit Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report35 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Iowa, Idaho, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, Nevada, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Stanbio AC power adapter for the HemoPoint H2 meter The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RAPIDPoint 405 Blood Gas Analyzer Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RAPIDPoint 500 Blood Gas Analyzer Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RAPIDLab 1245 Blood Gas Analyzer Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall RAPIDLab 1265 Blood Gas Analyzer Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall N Latex CDT Kit Siemens Healthcare Diagnostics has observed a negative bias for the carbohydrate-deficient transferrin (CDT) measurement when using the affected N Latex CDT… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereDelaware, Indiana, Kansas, Missouri and Virginia
- Medical device recall Duo-Flow XTP Straight Full Set The suture wings have the potential to crack or break. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Double Lumen CRRT/ABP Catheter Set The suture wings have the potential to crack or break. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Duo-Flow Double Lumen Soft Tip CRRT/ABP Catheter Set The suture wings have the potential to crack or break. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Duo-Flow IJ Full Tray The suture wings have the potential to crack or break. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Duo-Flow Catheter Full Tray The suture wings have the potential to crack or break. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Duo-Flow XTP Straight Full Set, RMS02105 RMS02108 The suture wings have the potential to crack or break. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Duo-Flow Double Lumen Catheter Only/Catheter Set The suture wings have the potential to crack or break. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY The suture wings have the potential to crack or break. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET The suture wings have the potential to crack or break. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DUO FLOW CUSTOM TRAYS The suture wings have the potential to crack or break. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT The suture wings have the potential to crack or break. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard Midstream Urine Collector with Rigid Funnel and Iodophor Prep Pads Medline notified BMD that the Aplicare Povidone Iodine (PVP-I) Prep Pads were not meeting the iodine assay level requirements to support 36 month expiration… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report24 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArkansas, California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, South Carolina, Tennessee, Texas, Utah and Washington
- Medical device recall Roche cobas p 612 pre-analytical system Sample material may potentially come in contact with the pipetting nozzle during operation of cobas p 612 pre-analytical system (63x) (LCP1) with non-filter… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereCalifornia, New York, Texas, Washington and Wisconsin
- Medical device recall Ceterix Disposable Knot Pusher / Suture Cutter Possible nonconforming blades may result in a higher than specified cut force required to cut the suture. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CIVCO Needle Guide The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall CIVCO Needle Guide The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medline 0.9 % Sodium Chloride Injection, USP 5 mL Packaged with an incorrect overwrap. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 27 states named PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Delaware, Florida, Georgia, Indiana, Louisiana, Massachusetts, Maryland, Minnesota, Mississippi, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington and West Virginia named
- Medical device recall P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830 This unit may be missing the screw/collet Assembly Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Haemonetics OrthoPAT System-Integrated Set OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs OrthoPAT¿ reservoirs are missing the cannula inside the reservoirs. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric… Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nucleic Acid Test Cartridges component (20-006-023) from the… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement Report17 statesnamed in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereArizona, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Michigan, Minnesota, Missouri, New Hampshire, Tennessee, Texas, Utah, Wisconsin and West Virginia
- Medical device recall Sysmex XN-Series Fluorocell PLT The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Carestation 620/650/650c, A1 and A2 (non-US distribution) anesthesia systems On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GE Carestation 30 anesthesia systems On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall GE 9100c NXT anesthesia systems On systems equipped with the Auxiliary Common Gas Outlet (ACGO), there is a potential for the auxiliary gas switch to unexpectedly switch from the ACGO… Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 5, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall FLOSEAL Special Applicator Tips in cartons labeled in part, “Floseal SPECIAL APPLICATOR TIPS***6 x Malleable… Baxter r recalled this device due to the use of an incorrect plastic formulation in the manufacture of the blue luer component of the FLOSEAL malleable tips. Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedSep 5, 2018ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, 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, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems Revised replacement instructions for the Li-ion battery packs used in BIS Vista and BIS View Monitoring Systems Class IIFDA’s classSep 5, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 5, 2018ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CPAP Mask Cushion A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement part resulted in incompatibility of the new cushion seal with… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedAug 29, 2018ClassClass IStatusTerminatedWhereNationwide, and Alabama, Connecticut, Florida, Georgia, Kentucky, Mississippi, North Carolina, New York, Tennessee and Texas named
- Medical device recall Handicare C Series Patient Lift Product Usage: A device used to lift and transport a patient from one place… Premature strap wear and breakage at maximum weight conditions (625 lbs.). Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Connecticut, Delaware, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Nebraska, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas and Wisconsin named
- Medical device recall Handicare P600 Series Patient Lift Product Usage: A device used to lift and transport a patient from one… Premature strap wear and breakage at maximum weight conditions (625 lbs.). Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Connecticut, Delaware, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Nebraska, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, Tennessee, Texas and Wisconsin named
- Medical device recall bioMerieux VITEK 2 Gram Positive Cefoxitin Screen, VITEK 2 Gram Positive AST for Oxacillin, VITEK SYSTEMS… Customer reports indicated an increase in the rate of non-detected MRSA in association with the VITEK 2 AST-P631 product. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 29, 2018ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall The Tri-Flo Subglottic Suction System Vyaire Medical has discovered potential patient safety risk with associated with the Tri-Flow Subglottic Suction System. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 29, 2018in FDA’s Enforcement Report18 statesnamed in where it went PublishedAug 29, 2018ClassClass IStatusTerminatedWhereArizona, California, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Massachusetts, Maryland, Minnesota, New Jersey, Ohio, Oklahoma, South Dakota, Texas, Washington and Wisconsin
- Medical device recall Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim urology systems facilitate… Software issue. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement Report30 statesnamed in where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Kansas, Kentucky, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim urology systems facilitate radiologic… Software issue. Class IIFDA’s classAug 29, 2018in FDA’s Enforcement Report30 statesnamed in where it went PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Kansas, Kentucky, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, Nevada, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall 3D TOP Ceiling Stand In rare cases of insufficient maintenance or high clinical workload, the first rope of the ceiling stand, which is designed to take the load, could break… Class IIFDA’s classAug 29, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedAug 29, 2018ClassClass IIStatusTerminatedWhereNationwide, and Florida, Illinois and New York 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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