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 8, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall Shuttle Select Slip-Cath Catheter Reports of catheter tip splits and or separation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 2, 2016ClassClass IStatusTerminatedWhereNationwide, and Georgia, Puerto Rico and US Virgin Islands named
- Medical device recall Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a… A manufacturing process may lead to catheter tip fracture and or separation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 2, 2016ClassClass IStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen… A manufacturing process may lead to catheter tip fracture and or separation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 2, 2016ClassClass IStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a… A manufacturing process may lead to catheter tip fracture and or separation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 2, 2016ClassClass IStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a… A manufacturing process may lead to catheter tip fracture and or separation. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 2, 2016ClassClass IStatusTerminatedWhereNationwide, and District of Columbia and Puerto Rico named
- Medical device recall Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer The Firm has discovered a Software bug. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering… Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 2, 2016ClassClass IStatusTerminatedWhereNationwide, and California, New York and Oregon named
- Medical device recall This reagent is for in vitro diagnostic use The Bond” Polymer Refine Detection and Novolink” Polymer Detection System may not provide adequate staining when using a detection protocol where one of its… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement Report37 statesnamed in where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereArkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Puerto Rico, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia
- Medical device recall BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance,… Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Evita Infinity V500 Ventilator The battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical and Neonatal Care was rapidly and unexpectedly… FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Stryker Aero-AL Impaction handle Reported jamming of the impaction handle when assembled to the Inserter guide at the threads. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 9131-001 Defibrillation Electrodes Defibrillation electrodes may increase electrical impedance over time. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee,… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibial,… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-constrained,… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee,… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous,… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented,… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee,… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial,… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes “The CPT Hip… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented “” Total hip… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented “” Total hip… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented “” Total hip… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint… LDPE bag containing the implant adheres to the highly polished implant surface. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BD FMC7 FITC Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expiration date listed on the vial label. Class IIIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedMar 2, 2016ClassClass IIIStatusTerminatedWhereNationwide, and Alabama, California, District of Columbia, Florida, Georgia, Illinois, Massachusetts, Maryland, New Jersey, New York, Oklahoma, Pennsylvania and Texas named
- Medical device recall AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic… There were two potential interference conditions identified with the way the tubing set attaches to the inserter. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips IntelliVue Measurement Module X1 The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips IntelliVue Module Measurement X2 The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Stryker Vitallium Wire The wire packages are correctly marked with a “NON-STERILE” label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare IntelliVue Info Center iX, A.0 866023 Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or… Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia… Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Specify 5-6-5 Lead, Specify 2x8 Lead Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Hill-Rom Bariatric Power Recliner, Product The recliners were shipped without the foot rest ottoman linkage side shields, which could result in consumer injury. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement Report39 statesnamed in where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector Convenience Kits contain an In-Vision-Plus Needleless IV Connector, code RYM5001 that is being recalled by the manufacturer, RyMed Technologies, LLC. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Georgia, Illinois, Pennsylvania, Tennessee, Texas and Virginia
- Medical device recall Syngo Plaza Picture archiving and communication system Siemens is releasing an updated software version to address several software issues including RGB images will show “?” since calculation of HU is not possible;… Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedMar 2, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, California, Connecticut, Florida, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New York, Ohio, Oregon, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a… Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad. Class IIFDA’s classMar 2, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 2, 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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