Medical devices, 2016
Shortlist up to four to read them side by side.
3,246 medical device recalls FDA’s Enforcement Report published in 2016, 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 5, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN SMN 10699533 Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Merge LIS software. There is a potential for duplicate container numbers to be created for patients. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and US Virgin Islands named
- Medical device recall PET Infusion Pump The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when… Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Dimension Vista IRON Flex reagent cartridges Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than… Class IIIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Dimension IRON Flex reagent cartridges Siemens Healthcare Diagnostics has become aware of deferoxamine interference with Dimension and Dimension Vista IRON assays at a different concentration than… Class IIIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Bard Fluoro-4 Silicone Ureteral Stent, Bard¿ Fluoro-4”, Silicone Ureteral Coil Stent Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is… Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is… Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent with Stent and Multi-… Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is… Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Totalis, RIGID and Totalis”I Flex ENDO KIT, Manufacturer: C.R Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is… Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Access Ostase Calibrators Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Access Ostase QC Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Colorado, Florida, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, North Carolina, New Jersey, New York, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall MEVION S250 Product Usage: Proton Radiation Therapy Completing Setup Without Program Move Complete Can Cause An Isocenter Error Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Missouri, New Jersey and Oklahoma named
- Medical device recall MEVION S250 Product Usage: Proton Radiation Therapy System Recovery of Incorrect Isocenter -operational change Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Missouri, New Jersey, Ohio and Oklahoma named
- Medical device recall MEVION S250 Product Usage: Proton Radiation Therapy System Software defect:2D projection of contours in Verity. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Missouri, New Jersey, Ohio and Oklahoma named
- Medical device recall The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate… Sorin Group USA, Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The ORCHESTRA PLUS Programmer A portable device, equipped with a microprocessor used to program and… Sorin Group USA, Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 4 Port “ON” Manifold ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transpac¿ IV Bifurcated Monitoring Kit 48”, 2 Disposable Transducers, 2 03 ml Intraflo¿ Flush Devices,… ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT WITH 2 BONDED STOPCOCKS, 72”, DISPOSABLE TRANSDUCER WITH 2 BONDED STOPCOCKS, 3 ML… ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV BIFURCATED KIT WITH SAFESET” RESERVOIR AND BLOOD SAMPLING PORTS, 84” TUBING, 2 SQUEEZE FLUSHES,… ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV BIFURCATED MONITORING KIT, 72” 2 DISPOSABLE TRANSDUCERS, with 2 STOPCOCKS, 2 3 ml SQUEEZE FLUSH,… ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV DISPOSABLE TRANSDUCER ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV DISPOSABLE TRANSDUCER MONITORING KIT WITH BONDED STOPCOCK AND 3mL SQUEEZE FLUSH ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (INTENDED FOR PATIENT MOUNT) ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transpac¿ IV Monitoring Kit, 60”, Disposable Transducer, 3 ml Squeeze Flush Device, Macrodrip ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT DISPOSABLE TRANSDUCER WITH BONDED STOPCOCK, 3 ML SQUEEZE FLUSH, MACRODRIP, 60”,… ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transpac¿ IV Monitoring Kit, 84”, Disposable Transducer, 3 ml Squeeze Flush, Macrodrip ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT NEONATAL, 24”, DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (INFUSION PUMP) ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT, 60”, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (POLE MOUNT) ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT, NEONATAL, 24”, WITH DISPOSABLE TRANSDUCER, 30 ML INTRAFLO¿ FLUSH (INFUSION PUMP) ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT, 9”, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (PATIENT MOUNT) ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV TRIFURCATED MONITORING KIT 60 INCH, 3 DISPOSABLE TRANSDUCERS, 3 3 ML SQUEEZE FLUSH, MACRODRIP… ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV TRIFURCATED MONITORING KIT, 84” 3 DISPOSABLE TRANSDUCERS WITH 2 STOPCOCKS 3 3 ML SQUEEZE… ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transpac¿ IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24” Arterial Pressure Tubing ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transpac¿ IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24” Arterial Pressure Tubing ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT WITH DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH AND MACRODRIP (POLE MOUNT) ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT, 60”, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MICRODRIP¿ (POLE MOUNT) ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT , 60”, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MICRODRIP¿ (POLE MOUNT) ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT WITH 2 SAFESET” BLOOD SAMPLING PORTS, 60” TUBING, DISPOSABLE TRANSDUCER, 3 ML… ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT, 72”, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT) ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT NEONATAL, 12”, 3 STOPCOCKS, DISPOSABLE TRANSDUCER, 30 ML SQUEEZE FLUSH (FOR USE… ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TRANSPAC¿ IV MONITORING KIT WITH SAFESET” RESERVOIR AND BLOOD SAMPLING PORT, 60” TUBING, DISPOSABLE… ICU Medical Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
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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