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 7, 2026.
3,246of 3,246 medical device recallsshown with your filters
The list
- Medical device recall BIOGRAPH mCT Flow 64-3R, MATERIAL NUMBER 10529160 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH mCT Flow 64-4R, MATERIAL NUMBER 10529161 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH mCT Flow Edge-3R, MATERIAL NUMBER 10528954 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH mCT Flow Edge-4R, MATERIAL NUMBER 10528955 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall BIOGRAPH mCT S(20)-4R, MATERIAL NUMBER 10534160 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph mCT-S(40) 3R, MATERIAL NUMBER 10248668 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph mCT-S(40) 4R, MATERIAL NUMBER 10248671 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph mCT-S(64) 3R, MATERIAL NUMBER 10248669 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph mCT-X 3R, MATERIAL NUMBER 10248673 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SYS IVK, Bio mCT-S(40) 3R->4R Upgrade, MATERIAL NUMBER 10250743 The Siemens Biograph TruePoint systems are… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SYS IVK, Bio mCT-X 3R->4R Upgrade, MATERIAL NUMBER 10250745 The Siemens Biograph TruePoint systems are… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Biograph 16 TruePoint, MATERIAL NUMBER 10249555 The Siemens Biograph TruePoint systems are combined X-Ray… Siemens Medical Solutions, Molecular Imaging has become aware of a potential for unexpected SUV values if a non-Siemens phantom is used for calibration. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall SIOOA I (EP I84) Rabbit Monoclonal Antibody Cell Marque became aware of some lots of SIOOA I (EP I84) Rabbit Monoclonal Antibody, catalogue numbers 408R-14, 408R-15, and 408R-16, that exhibited an… Class IIFDA’s classJun 29, 2016in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereCalifornia, Massachusetts and Washington
- Medical device recall CytoVision Image Analysis and Capture System, an automated cell-locating device Systems have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system. Class IIIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Histoplasma Yeast Complement Fixation Antigen Dilute Ref# H30150 The fungal antigens and positive controls… The device was found to have bacterial contamination. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide, and California, Iowa, Indiana, Kentucky, Massachusetts, North Carolina, New York, Ohio, Utah and Virginia named
- Medical device recall Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay Exhibits a greater than 10% change in results in samples with biotin levels up to 10 ng/mL (41 nmol/L). Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Sharpoint Polypropylene Blue Monofilament 6”/15cm 9-0 USP, Product No Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6”/15cm 9-0 USP because it may contain Black Nylon 9-0 suture. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement Report9 statesnamed in where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereGeorgia, Kansas, Massachusetts, Maine, Michigan, Minnesota, Ohio, Tennessee and Texas
- Medical device recall Fujifilm Synapse PACS software version 4.4.000, Fujifilm Synapse PACS software version 4.4.001, Fujifilm… Synapse cannot display image files, DICOM SR files, and/or Annotation files. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement Report6 statesnamed in where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereCalifornia, Florida, Kansas, Nebraska, New York and Pennsylvania
- Medical device recall Crit Line in a Clip (CLiC) Use of the Blood Pressure Graph located on the Crit-Line screen of the 2008T Hemodialysis Machine may result in a frozen screen, possibly causing the blood… Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Myriad handpiece Tissue morcellator This recall has been initiated due to a defective component within the handpiece which will cause the handpiece to fail. Class IIFDA’s classJun 29, 2016in FDA’s Enforcement Report13 statesnamed in where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereArkansas, California, Georgia, Iowa, Illinois, Indiana, Maryland, Michigan, North Carolina, Ohio, Oregon, Texas and Wisconsin
- Medical device recall 6534-08N InterActive¿ Implant Open-Tray Transfer Narrow The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged instead of the InterActive Implant Open-tray Transfer Narrow,… Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide, and Florida, Missouri, Nebraska, Oregon, Texas, Virginia and Washington named
- Medical device recall Germ Terminator, Toothbrush Steam Sterilization for Oral Health CEG Enterprises, LLC is recalling Germ Terminator Toothbrush Sanitizer GT100 due to the following issues: UL label believed to be not genuine; discoloration of… Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall EV3 EverFiex” Self-expanding Peripheral Stent System, Sterilized using Ethylene Oxide Medtronic is issuing a medical device recall to return product potentially associated with an outer box mislabel issue for two Protege EverFiex” Self-expanding… Class IIFDA’s classJun 29, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 29, 2016ClassClass IIStatusTerminatedWhereNationwide, and Louisiana and Wisconsin named
- Medical device recall AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically… CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or… CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to… CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to… CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically… CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended… CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient… CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically… CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad… CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or… CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad… CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad… CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended… There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement Report51 statesnamed in where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and Wyoming
- Medical device recall Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid) Inability to deploy the stent or partial stent deployment. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Cordis PRECISE (R) RX Nitinol Stent System (Biliary) Inability to deploy the stent or partial stent deployment. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Ariol is an automated scanning microscope and image analysis system An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated… Class IIIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile Product incorrectly packaged. Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportColoradothe one state its words name PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereColorado
- Medical device recall POROUS PATELLA 32MM X 10MM - 00587806532 POROUS PATELLA 35MM X 10MM- 00587806535 POROUS PATELLA 38MM X 10MM -… Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TM CR TIB SZ 3 C-H, 10MM- 00588604310 TM CR TIB SZ 3 C-H, 12 mm - 00588604312 TM CR TIB SZ 3 C-H, 14MM -… Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TM LPS TIB SZ 3 C/D, 10MM - 00588605310 TM LPS TIB SZ 3 C/D, 12MM - 00588605312 TM LPS TIB SZ 3 C/D, 14MM -… Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TM MONO TIB STR GRN SZ 5 - 00588606510 TM MONO TIB STR GRN SZ 5 12MM - 00588606512 TM MONO TIB STR GRN SZ 5… Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall REV. SHELL LINER 0D 28X48 00700504828 REV. SHELL LINER 10D 28X50 00701005028 REV. SHELL LINER 10D 28X52… Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall 00720504022 ACETAB.CUPW/SH,0DEG,22MMX40MM 00720504222 ACETAB.CUPW/SH,0DEG,22MMX42MM 00720504622… Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October… Class IIFDA’s classJun 22, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 22, 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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