Medical devices, 2018
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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 (1) ARROWg+ard Blue(R) MAC(TM) Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall AGB+ Multi Lumen Central Venous Catheterization (CVC) Kit Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard Technology Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall Multi-Lumen Hemodialysis Catheterization Kit for High Volume Infusions Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall (1) Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and… Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall (1) Arterial Catheterization Kit Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall (1) Central Venous Catheterization Kit Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall (1) Access Tray Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall ARROWg+ard Blue¿ CVC Kit Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall Arrowg+ard Blue(R) PSI Kit Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall AGB+ Multi Lumen CVC Kit Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall ARROWg+ard Blue¿ Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and District of Columbia named
- Medical device recall Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system “Chattering” when cutting burrs are used in bone. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement Report3 statesnamed in where it went PublishedApr 18, 2018ClassClass IIStatusOngoingWhereMichigan, New Mexico and Texas
- Medical device recall PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CT-1 Needle Three (3) lots were distributed with the incorrect expiry date on the label. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle Three (3) lots were distributed with the incorrect expiry date on the label. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PDS Plus Antibacterial (Polydioxanone) Suture Size 0 PDS Plus Violet 36 Single Armed CTB-1 Needle Three (3) lots were distributed with the incorrect expiry date on the label. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AQUIOS CL Flow Cytometer System The device may process the same sample with two different sample IDs and sample information while using the single tube loader, which has the potential for… Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall 6.5” (17 cm) Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating Luer, Bulk… The infusion sets were manufactured with an incorrect spin collar. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, South Carolina and Texas named
- Medical device recall 6.5” (17 cm) Appx. 0.57 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, NanoClave¿ T-Connector, 4 Clamps, Rotating… The infusion sets were manufactured with an incorrect spin collar. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, South Carolina and Texas named
- Medical device recall 7” Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item AH7262 The infusion sets were manufactured with an incorrect spin collar. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, South Carolina and Texas named
- Medical device recall 7” Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item… The infusion sets were manufactured with an incorrect spin collar. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, South Carolina and Texas named
- Medical device recall 5” (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case,… The infusion sets were manufactured with an incorrect spin collar. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, South Carolina and Texas named
- Medical device recall 14 cm (5.5”) Appx 0.27 ml, Smallbore Ext Set w/SURPLUG¿ Nano T-Connector, Clamp, Rotating Luer, 50 pouches… The infusion sets were manufactured with an incorrect spin collar. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Colorado, Florida, South Carolina and Texas named
- Medical device recall AUTO REF/KERATOMETER ARK-1s There is possibly a difference between the measured dioptric value of the subjective measurement mode and the objective measurement mode on ARK-1s. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement Report26 statesnamed in where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Maryland, Michigan, Missouri, Montana, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall VOLISTA StandOP Surgical Light The manufacturer received complaints indicating that the device’s central handle holder detaches easily from the handle holder ring on the light head during… Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Florida, Iowa, Idaho, Kansas, Kentucky, Maine, Missouri, Nebraska, New York, Oregon, Tennessee, Texas, Utah and Washington named
- Medical device recall Spinal Jaxx Interbody Fusion Device The implant size is incorrectly etched on the implant. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medical device recall Foot Controls During continuous postmarket surveillance activities, we have noticed a potential malfunction of individual foot controls of the type S-N1/S-N2. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Magstim Rapid Therapy System consisting of: Rapid Mainframe, Rapid Single Power Supply Unit , Rapid User… Users manuals not supplied with 4800-00T US Rapid Therapy System Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, California, Georgia, Hawaii, Kansas, Massachusetts, Maryland, Missouri, North Carolina, New Jersey, New York and Texas named
- Medical device recall First aid/emergency kits containing Honeywell eyewash: CSM kit number Kit/cabinet Description CSM Eyewash#… Firm is recalling first aid/emergency kits and cabinets which contain Honeywell Eyewash (3 lots) which is being recalled due to leaking bottles. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Georgia, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Tennessee, Texas, Virginia and Washington named
- Medical device recall Bard(R) Premature Infant Feeding Tube, ENFit(TM) BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard(R) Infant Feeding Tube, ENFit(TM) BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM) BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard(R) Premature Infant Feeding tube, ENFit(TM) BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Doyen-Collin Mouth Gag 120MM/ General Instruments The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable. Class IIIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Strauss Penis Clamp 130MM/General Instruments The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable. Class IIIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Normed Charcot Osteotome Chisel (Various sizes) Product may contain a gap between the handle and metal chisel which can lead to failure to properly disinfect or sterilize between use. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement Report4 statesnamed in where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereColorado, Illinois, Indiana and Texas
- Medical device recall BECKMAN COULTER iQ200 Series Urine Microscopy Analyzer Beckman Coulter has determined that there is a potential for under-reporting casts. 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 ORTHOFIX, Connector System, SMALL SET SCREW Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN:… 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 ORTHOFIX, Connector System, LARGE SET SCREW Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN:… 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 Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for… The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as… Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall iQ200 Series Urine Microscopy Analyzer with Barcode Reader iQ200 Series Urine Microscopy Analyzer may intermittently fail to read urine sample dilution barcode labels causing erroneous results that could delay… Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Latex Rebreathing Bags These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber… Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Rectal Catheters These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber… Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Simplastic Suprapubic Puncture Instruments These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber… Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Baker Jejunostomy Tubes These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber… Class IIFDA’s classApr 18, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 18, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hamilton-C2 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally… After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 18, 2018ClassClass IIStatusOngoingWhereArizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont and Washington
- Medical device recall Hamilton-C3 Ventilator Unit Intended to provide ventilator support to adults and pediatrics and optionally… After two and a half years, the battery fuel gauge may indicate a higher battery charge than what is available. Class IIFDA’s classApr 18, 2018in FDA’s Enforcement Report29 statesnamed in where it went PublishedApr 18, 2018ClassClass IIStatusOngoingWhereArizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont and Washington
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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