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 Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports, 84” Tubing, Disposable… ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transpac IV Monitoring Kit with 2 SafeSet 84” Arterial Pressure Tubing, Reservoir, 03 mL Squeeze Flush and 2… ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transpac IV Monitoring Kit with SafeSet Reservoir and Blood Sampling Port, 24” Tubing, Disposable Transducer,… ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 84”, 3.3mL Squeeze… ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transpac IV Trifurcated Monitoring Kit with 84” SafeSet Reservoir, 03 ml Squeeze Flush and Needleless Valves ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Single Monitoring Kit with 30mL Flush Device ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monitoring Kit with 30mL Flush Device ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Triple Line SafeSet Kit with 03mL Flush Device ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Double Kit with SafeSet and 03mL Flush Device ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monitoring Kit with 03mL Flush Device ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SafeSet Kit with 30 mL Flush Device ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bifurcated SafeSet Kit with 03mL Flush Device ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Pediatric Kit with 30mL Flush Device ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 5 Port OFF Manifold with Transpac IV ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monitoring Kit with TP4, 30 ml Squeeze Flush and Needleless Valve ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transpac IV Monitoring Kit with SafeSet 84” Arterial Pressure Tubing, Reservoir, Squeeze Flush and Needleless… ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TP4 Kit with 10cc SafeSet Reservoir, Needleless Valve, Filter Millex and Admin Set ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transpac IV Monitoring Kit with 03 ml Squeeze Flush, SafeSet Reservoir, 2 Needleless Valves, Mounts and… ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve ICU Medical Inc. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall AirStrip Sense4Baby Belt clip may become detached causing electronic components to be exposed. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereArkansas and Louisiana
- Medical device recall Option-vf Urinary Catheter During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Maryland, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Washington and Wisconsin
- Medical device recall Option-vm Urinary Catheter During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement Report15 statesnamed in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Florida, Illinois, Indiana, Massachusetts, Maryland, New Jersey, New York, Oregon, Pennsylvania, Tennessee, Washington and Wisconsin
- Medical device recall The Bigger-Better-Bladder, TM 2 With 3/8”ID tubing, 72” long tubing, ITEM BBB38-72 A device that isolates… The seal between the balloon and the housing may leak. Class IIFDA’s classSep 21, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereLouisiana, Michigan, New York, Ohio, Oregon and Texas
- Medical device recall LAUREATE World Phaco System Steps 16-25 are missing from the LAUREATE Multipak FMS Directions for Use (DFU) Class IIFDA’s classSep 21, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 21, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 14, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 14, 2016ClassClass IStatusTerminatedWhereNo state named
- Medical device recall Acecide-C High Level Disinfectant & Sterilant 875 mL Certain lots of the acid solution in Acecide-C are degrading faster than normal. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedSep 14, 2016ClassClass IIStatusTerminatedWherePennsylvania
- Medical device recall Merge RadSuite software When RadSuite is used with IPID (Issuer of Patient ID) as a part of the “Patient Identifier,” it is possible in some circumstances that the demographics of one… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereAlabama, Michigan, Missouri, Pennsylvania, Tennessee and Texas
- Medical device recall NOMAD Pro Packaged X-Ray System, Part Number 08500009; NOMAD Pro Vet Packaged X-Ray System, Part Number… Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to “overheat”, “melt”, “smoke” and/or “ignite.”… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report52 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall NOMAD Pro2 Packaged X-Ray System, Part Number 08500021; NOMAD Pro2 Packaged X-Ray System Black, Part Number… Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to “overheat”, “melt”, “smoke” and/or “ignite.”… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report52 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereAlaska, 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, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ArjoHuntleigh Sara Combilizer ArjoHuntleigh has concluded that a device tipping hazard may occur on the current Sara Combilizer lifting mechanism, providing a potential for risk to the… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereAlabama, California, Colorado, Connecticut, Florida, Illinois, Massachusetts, Maryland, Michigan, North Carolina, New York, Texas and Virginia
- Medical device recall ReliaMed¿ Silver Alginate/CMC On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportOhiothe one state its words name PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereOhio
- Medical device recall ReliaMed¿ Alginate/CMC On 08 January 2015 AMS Sole Customer for the products notified AMS of the issue after discovering the misplaced IFUs during its review of packaging in its… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportOhiothe one state its words name PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereOhio
- Medical device recall Medical Linear Accelerator There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of… Class IIFDA’s classSep 14, 2016in FDA’s Enforcement Report20 statesnamed in where it went PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Florida, Georgia, Kentucky, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, Washington and West Virginia
- Medical device recall Plum A+ Hyperbaric Infusion Pump The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall Plum A+ Infusion Pump The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall Plum A+ Infusion Pump The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands named
- Medical device recall Plum A+3 Infusion Pump The fluid shield diaphragm for the Plum A+ Infusion pumps was undersized, possibly resulting in alarms and delay or interruption of therapy. Class IIFDA’s classSep 14, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 14, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico and US Virgin Islands 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.”
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