Medical devices, 2014
Shortlist up to four to read them side by side.
3,059 medical device recalls FDA’s Enforcement Report published in 2014, 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.
3,059of 3,059 medical device recallsshown with your filters
The list
- Medical device recall Catalys Precision Laser System (United States) - Catalys-U: Catalys Precision Laser System (International) -… Potential for unexpected heating of the transformer mounting bolt located within the system chassis and the subsequent melting of a non-slip computer shelf… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Hawaii, Iowa, Illinois, Kentucky, Massachusetts, Maine, Michigan, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas and Utah named
- Medical device recall Nova StatStrip/StatSensor Hospital Blood Glucose Meter Revised Battery Instructions for Removal and Expiration Date due to battery swelling and cell leakage Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five… An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.3 used in Vantage Panoramic X-Ray systems. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Massachusetts, North Carolina, New Hampshire, New Jersey, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Virginia and Wisconsin named
- Medical device recall Arthrocare SPORTS MEDICINE, Knot Pusher A sharp edge on the cannulated tip of the device may damage or cut a suture. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and California, Florida, Georgia, Illinois, Indiana, Kentucky, Minnesota, Missouri, New York, Ohio, Texas and Wisconsin named
- Medical device recall Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device, OrALert Oral Fluid Drug Screen Device,… Alere initiated this recall of certain lots of the Oral Fluid Drug Screen Device because the sponge may become dislodged from the Saliva Collector handle prior… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Pennsylvania and Virginia
- Medical device recall ***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ***REF XMAX***XMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ***REF MICROMAX***microMax Handpiece***Rx Only***Manufacturer: The Anspach Effort, Inc The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall ***REF IMRI-MOTOR***iMRI Handpiece The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot… Class IIFDA’s classJan 15, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall NanoClave Connector ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 6” (15 cm) Appx 0.26 ml, Smallbore Ext Set with NanoClave T-Connector, Clamp, Luer Slip, Part No. A1000, Item… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 6” (15 cm) Appx 0.58 ml, Smallbore Trifuse Ext Set w/3 NanoClave¿, 3 Clamps, Rotating Luer, Part No. A1000,… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 183 cm (72”) Smallbore Quadfuse Ext Set w/4 NanoClave¿ (Yellow, Green Rings), 4 Anti-Syphon Valves, 0.2… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 184 cm (72”) Smallbore Bifuse Ext Set w/2 NanoClave¿, 2 Anti-Syphon Valves, 0.2 Micron Positive Filter,… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 31 cm (12”) Smallbore Bifuse Ext Set w/2 NanoClave¿, Orange Ring, 2 Anti Syphon Valves, 0.2 Micron Postive… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall NanoClave Stopcock ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 17 cm (7’’) Ext Set w/NanoClave¿, 2 Gang 4-Way NanoClave¿ Stopcock, Rotating Luer, Part No. A1000, Item No.… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 6” (15 cm) Appx 0.26 ml, Smallbore Ext Set w/Clamp, NanoClave¿ TConnector, Rotating Luer, Part No. A1000,… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 7” (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, Clamp, Rotating Luer, Part No.… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 7” (18cm) Appx 0.32 ml, Smallbore Ext Set w/Remv MicroCLAVE¿ Clear, NanoClave¿ T-Connector, Clamp, Rotating… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 8” (20 cm) Appx 0.51 ml, Smallbore Ext Set w/MicroCLAVE¿ Clear, 0.2 Micron Filter, NanoClave¿ T-Connector,… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 78” Ext Set w/Check Valve, CLAVE¿ Clear, Remv 2 Gang 4-Way Stopcocks, NanoClave¿, NanoClave¿ T-Connector, 4… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 11” Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave”, 3 Clamps, Rotating Luer ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 8” (20 cm) Appx 0.49 ml, Smallbore Bifuse Ext Set w/2 NanoClave”, 2 Clamps, Luer Lock, Part No. A1000, Item… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 8” Smallbore Pentafuse Ext Set w/5 NanoClave”, 5 Clamps, Rotating Luer ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 10” Smallbore Pentafuse Ext Set w/5 NanoClave”, 5 Clamps, Rotating Luer ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 87” (221 cm) Appx 2.9 ml, Smallbore Trifuse Ext Set w/NanoClave¿, 0.2 Micron Filter, 4 Clamps, Rotating Luer,… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 13” Smallbore Ext Set w/4 Gang 4-Way Stopcock w/Baseplate, 4 NanoClave¿, Rotating Luer ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 14” (36 cm ) Appx 0.50 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave¿, 2 Clamps, Rotating Luer, Part… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 103” (262 cm) Appx 3.9 ml, Smallbore Bifuse Ext Set w/NanoClave”, Anti-Siphon Valve, Check Valve, 2 Clamps,… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 8” Ext Set w/NanoClave” Stopcock, Clamp, Rotating Luer ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 6” (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave” TConnector, Rotating Luer, Part No. A1000,… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 6” (15 cm) Appx 0.27 ml, Smallbore Ext Set w/Clamp, NanoClave” TConnector w/Luer Slip, Part No. A1000, Item… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 7” (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave”, Clamp, Rotating Luer, Part No.… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 7” (18 cm) Appx 0.26 ml, Smallbore Ext Set w/MicroClave¿ Clear, NThe ICU Needleless Connector is a single… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 7” (18 cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave” T-Connector, Clamp, Rotating… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 10” (25 cm) Appx 2.9 ml, Trifuse Ext Set w/3 MicroClave¿ Clear, Tri- Connector, NanoClave” T-Connector, 4… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 106” (269 cm) Appx 7.8 ml, Transfer Set w/Check Valve, NanoClave” TConnector, Anti-Siphon Valve, 2 Clamps,… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 78” Ext Set w/2 BCV-Clave¿, Remv 2-Gang 4-Way Stopcocks, NanoClave” T-Connector, 4 Clamps, Rotating Luer, 3… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 7” (18 cm) Appx 0.24 ml, Smallbore Ext Set w/NanoClave”, Clamp, Luer Lock, Part No. A1000, Item No. K7095-001… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 6” (15 cm) Appx 0.37 ml, Smallbore Bifuse Ext Set w/2 NanoClave”, 2 Clamps, Luer Lock, Part No. A1000, Item… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 6” (15 cm) Appx 0.56 ml, Smallbore Trifuse Ext Set w/3 NanoClave”, 3 Clamps, Luer Lock, Part No. A1000, Item… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 7” (18 cm) Appx 0.31 ml, Smallbore Ext Set w/2 NanoClave”, Clamp, Rotating Luer, Part No. A1000, Item No.… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 10” (25 cm) Appx 0.41 ml, Smallbore Ext Set w/MicroClave¿ Clear, NanoClave”, Clamp, Rotating Luer, Part No.… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 10” (25 cm) Appx 0.38 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave”, Clamp, Luer Lock, Part No.… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 7” (18 cm) Appx 0.33 ml, Smallbore Ext Set w/NanoClave”, Clamp, Rotating Luer, Part No. A1000, Item No.… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 11” Smallbore Bifuse Ext Set w/1.2 Micron Filter, NanoClave”, 3 Clamps, Rotating Luer ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
- Medical device recall 13” Pentafuse Smallbore Ext Set w/NanoClave”, 1.2 Micron Filter, 3 MicroClave¿ Clear (Yellow, Red, Green… ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. Class IIFDA’s classJan 15, 2014in FDA’s Enforcement Report14 statesnamed in where it went PublishedJan 15, 2014ClassClass IIStatusTerminatedWhereAlabama, California, Georgia, Hawaii, Illinois, Kentucky, North Carolina, New Hampshire, Ohio, Tennessee, Texas, Utah, Vermont and Wisconsin
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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