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 TRIFURCATED DISP 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 ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP., Item No. 46086-21 The Transpac… 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 WITH 03ML FLUSH DEVICE FOR CARLE CLINIC 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 TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN 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 DISPOSABLE TRANSDUCER KIT W/03ML FLUSH DEVICE FOR JOHNS HOPKINS/BAYVIEW 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 FOR GENESIS HEALTH CARE 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 WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE 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/30ML Flush Device for Monongalia General Hosp 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 CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS HEART HOSP 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 WITH 03ML FLUSH DEVICE FOR CONCORD HOSP. 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 ARTERIAL PRESSURE KIT W/03ML FLUSH DEVICE FOR LEBONHEUR CHILDRENS HOSP. 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 PERFUSION KIT FOR UNIV 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 TRIPLE PRESSURE KIT W/03ML FLUSH DEVICE FOR UNIV 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 FOR SALINA REGIONAL 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 PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP. 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 OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP. 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 KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY 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 KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY 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 WITH 03ML FLUSH DEVICE FOR NYU MED CTR 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 QUAD KIT WITH THREE TRANSPAC¿ AND 03ML FLUSH DEVICES FOR ST 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/30 ML FLUSH DEVICE FOR EGLESTON HOSP. 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 Neonate Kit With 30 ml Flush Device For Driscoll Foundation For Children 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, 03 ml Flush Device, Waste Bag, HPT, Syringe, TP4 and 30 ml Contrast… 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 PTCA KIT W/03ML FLUSH DEVICE FOR WILLIAMSPORT HOSP 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 CARDIAC CATH LAB KIT FOR PRESBYTERIAN INTERCOMMUNITY HOSP. 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 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, TP4, SYRINGES & 30 ml BURETTE 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 SAFESET” KIT W/03ML FLUSH DEVICE FOR HOLMES REG 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 PERFUSION KIT W/03ML FLUSH DEVICE FOR NE REGIONAL MED 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 QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP. 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 MK W/03ML FLUSH DEVICE FOR UNIV 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 TRANSDUCER KIT FOR MEDICAL CTR 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 TRIPLE (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-65 The… 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 SINGLE (1) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-66 The… 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/Waste Bag, dyePod¿, Sosa Spike & Syringe 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/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and 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 CATH LAB KIT w/3 PORT “OFF” MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4 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/4 PORT “ON” MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP & 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 4 PORT “OFF” MANIFOLD, w/HP STOPCOCK, WASTE BAG ASSY, 10 cc SYRINGE & AD SETS 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 2 PORT RIGHT “OFF” MANIFOLD w/ADMIN SET 72” PT, 3 WAY STOPCOCK, TP4 & 1 WAY STOPCOCK 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/03 ml Squeeze Flush, Pressure Tubing, Guidewire, 10 cc Syringes and 3 Way Stopcock 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 DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET 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 Quad Kit W/03ML Flush Device, Mounts, Reservoir & 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 CARDIAC KIT WITH 03 ml 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¿ 4 kit w/72” Macrodrip¿ 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 5 Port “OFF” Manifold w/TRANSPAC¿ IV 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/Waste Bag System, 3 Port “OFF” 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 Right Heart Cath Lab Kit w/2 Port “OFF” Manifold 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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