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 6, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall TP4 Monitoring Kit w/84” Safeset” Reservoir, 03 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 Trifurcated Monitoring Kit w/84” Safeset” Reservoir, TP4, 03 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¿ w/Safeset Reservoir, Squeeze 03 ml 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 TRIFURCATED MONITORING KIT 72”, 3 DISPOSABLE TRANSDUCERS, 3 3 ML INTRAFLO¿ FLUSHES, 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 w/ Safeset Reservoir, 24” Tubing,03 ml Intraflo¿ 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 w/Safeset 72” Pressure Tubing, Reservoir, 03 ml Squeeze Flush and 2 Needleless… 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, 60”, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP AND RED PLUGS 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, Red Stripe Pressure… 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 Monitoring Kit, 60”, Disposable Transducer, 30 ML Intraflo¿ Flush, Pall Air Filter, 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 w/Safeset 84” Arterial Pressure Tubing, Reservoir, Squeeze Flush and 2 Needleless… 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, 03 ml Squeeze Flush, Blue Stripe Pressure Tubing, 3 Way Stopcocks, Blue Plugs and… 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/03 ml Squeeze Flush and 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 Bifurcated Transpac¿ IV Monitoring Kit w/03 ml Squeeze Flush Device, Red and Blue Stripe PT 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 Trifurcated Transpac¿ IV w/03 ml Squeeze Flush Device, 130” Safeset” Reservoir 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 w/Safeset” Blood Sampling Port and 03 ml Squeeze Flush Device 10 cc Sheathed… 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/03 ml Squeeze Flush Device, Arterial Safeset” Reservoir and Needleless Valves 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 w/03 ml Squeeze Flush Device, Arterial Safeset” Reservoir and… 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”, 03 ml Squeeze Flush Device, 2 3 Way Stopcocks and 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 w/Arterial 84” Safeset” Reservoir, 03 ml Squeeze Flush Device and Needleless… 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 w/Stopcocks w/o Cap and Covers 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 Kit w/2 3-Way Stopcocks and 48” Pressure TBG 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 w/84” Safeset” Reservoir, 03 ml Squeeze Flush Device, Needleless… 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” w/03 ml Squeeze Flush Device, Red, Blue and Yellow Stripe 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/84” Red Stripe TBG and 03 ml Squeeze Flush Device 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/ Safeset” Reservoir and Blood Sampling Port, 03 ml Squeeze Flush Device,… 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 w/03 ml Squeeze Flush Device, PT Tubings, 3-Way Stopcocks and Admin Set 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 Cath Lab Kit w/3 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 Cath Lab Left Heart Kit w/3 Port Manifold “OFF” 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 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 Expression MR IBP DPT Kit, I/N, Box 20 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 CATH LAB KIT W/3 PORT “ON” MANIFOLD, WASTE BAG, SYRINGE & TP4 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 LEFT HEART KIT 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 Atrium Medical 8 Fr Trocar catheter, Sterile Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 23, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Atrium Medical 10 Fr Trocar catheter, Sterile Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 23, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Atrium Medical 12 Fr Trocar catheter, Sterile Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 23, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Atrium Medical 16 Fr Trocar catheter Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 23, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Atrium Medical 20 Fr Trocar catheter, sterile Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 23, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Atrium Medical 24 Fr Trocar catheter, Sterile Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 23, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Atrium Medical 28 Fr Trocar catheter, Sterile Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 23, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall Atrium Medical 32 Fr Trocar catheter, Sterile Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 23, 2016ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall RF MultiGen¿, 0406-900-000 Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen¿ Generator, because the… Class IIIFDA’s classNov 23, 2016in FDA’s Enforcement Report49 statesnamed in where it went PublishedNov 23, 2016ClassClass IIIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall C-Max” Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile Defect; The contact part could possibly separate from the electrode affecting to functionality of the device. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereFlorida, Georgia, Louisiana, Ohio, Virginia and Washington
- Medical device recall Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) released on July 11, 2016 Roche Diabetes Care, Inc. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement Report45 statesnamed in where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereAlabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia
- Medical device recall FlexLab, Accelerator a3600 and Aptio Automation are modular systems designed to automate Pre-Analytical and… Inpeco received several notifications from the field about burnt schuko sockets. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNew York and Texas
- Medical device recall Alere Triage Total 5 Control Level 1 Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card. Class IIFDA’s classNov 23, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the… Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the affected lots may cause, on average, a positive proportional… 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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