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 Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable Megadyne Medical Products, Inc. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Minnesota, New Jersey, New Mexico, Pennsylvania and Texas
- Medical device recall HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis IHC PR Breast Tissue Manual Read… In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional information to clarify that the use of Digital IHC Breast/ER/Dako… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report12 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Florida, Minnesota, Mississippi, North Carolina, New Jersey, New York, Ohio, Pennsylvania, Texas and Washington
- Medical device recall Treatment packs used on the VisuMax Laser Keratome Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNevadathe one state its words name PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNevada
- Medical device recall RetCam 3, RetCam Portable and RetCam Shuttle Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, District of Columbia, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New Jersey, New Mexico, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Dakota, Tennessee, Texas, Utah and Virginia named
- Medical device recall Philips HeartStart MRx Monitor/Defibrillator MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend… Mindray has identified two issues with the Panorama Central Station. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Smith & Nephew RENASYS Soft Port Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Mississippi, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Mississippi, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Smith & Nephew RENASYS-F XL with Soft Port Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Mississippi, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Smith & Nephew RENASYS-Gauze with Soft Port Kit Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Mississippi, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Mississippi, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Mississippi, Montana, North Carolina, New Jersey, Nevada, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall GE Healthcare, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Innova 2121IQ, Innova… GE Healthcare has become aware of a potential safety issue involving the innova systems. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Boston Scientific, RunWay Guide Catheter, UPN H749389696640 The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportTexasthe one state its words name PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereTexas
- Medical device recall MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a… The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600 STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY¿ SixCess Challenge Packs incorrectly identifies the lot as Lot… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Illinois, Louisiana, Maine, Michigan, North Carolina, Ohio, Oklahoma, Virginia, Wisconsin and West Virginia named
- Medical device recall Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for… During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental… During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments… During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in… During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in… During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall VerifyNow IIb/IIIa Test Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Device Name: ABX PENTRA ML HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium… Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850 GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R),… The firm has determined the product may fail to dispense the sample to the agar plate resulting in a “failure to dispense” in conjunction with urine specimens. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report25 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlaska, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Missouri, North Carolina, New Jersey, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Cannabinoids DAU Calibrator Control Level 1 Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia, Louisiana, North Carolina, South Carolina and Texas
- Medical device recall Cannabinoids DAU Calibrator Control Level 1 Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report7 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Florida, Georgia, Louisiana, North Carolina, South Carolina and Texas
- Medical device recall 4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall 4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall 4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall 4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall 4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall 4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall 4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall 4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall G1777: Umbilical issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U issue with the plunger tip of the Portex¿ Arterial Blood Sampling Line Draw Syringes Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report40 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS… Class IIIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The… When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CELLTRACKS ANALYZER II¿ (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II¿ is a semi-automated… Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II¿. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gyrus ACMI Disposable Falope-Ring Band Applicator Kits Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may… Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external… Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement Report42 statesnamed in where it went PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. Class IIFDA’s classMar 19, 2014in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 19, 2014ClassClass IIStatusTerminatedWhereNationwide, and Guam 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.”
Your shortlist0 of 4
Add one more to compare.