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 Optisure Dual Coil Defibrillation Leads Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the SVC shock coil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2016ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Fukuda Denshi patient monitor A possible malfunction where a Short-term Battery Error message has appeared and has been traced back to a bad (damaged) Lithium-Ion capacitor (Short-term… Class IIFDA’s classJan 27, 2016in FDA’s Enforcement Report10 statesnamed in where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereColorado, Idaho, Kansas, Michigan, Missouri, Oregon, Pennsylvania, Texas, Utah and Wisconsin
- Medical device recall Excella II Rod Innovasis recalled two lots of Excella II titanium rods which were packaged using each other’s labels. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement Report4 statesnamed in where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereCalifornia, Kansas, Ohio and Texas
- Medical device recall Accusorb MRI MAC7001 When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and New York named
- Medical device recall Accusorb MRI MAC7002 When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and New York named
- Medical device recall Accusorb MRI MAC7004 When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and New York named
- Medical device recall Accusorb MRI MAC7007 When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and New York named
- Medical device recall Accusorb MRI MAC7008 When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and New York named
- Medical device recall Accusorb MRI MAC7003 When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and New York named
- Medical device recall Accusorb MRI MAC7005 When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and New York named
- Medical device recall Accusorb MRI MAC7006 When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and New York named
- Medical device recall Accusorb MRI MAC7009 When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and New York named
- Medical device recall Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI… When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and New York named
- Medical device recall Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI… When not used correctly, Accusorb MRI products may overheat and lead to patient injury. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Massachusetts and New York named
- Medical device recall Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series The Serial I.D. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended… Potential for the female luer component of the InVision-Plus IV connector to crack during use. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall InVision-Plus CS Needleless IV Connector Potential for the female luer component of the InVision-Plus IV connector to crack during use. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall GE Healthcare, Aespire 7900, 1009-9012-000 & Aespire View, 1009-9212-000 The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical… Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare, Aestiva 7900, 1006-9305-000 The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical… Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare, Aestiva MRI, 1006-9310-000 The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical… Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare, Aisys, 1011-9000-000 The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical… Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall GE Healthcare, Aisys CS2,1011-9050-000 The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical… Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall Anesthesia device service kits The Drive Gas Check Valve of certain Anesthesia products could become stuck in a fixed open position, which could cause pressure to build in the mechanical… Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medical device recall IBA Dosimetry GmbH Lift Table Type 4320 When the electric lift table is connected to the mains power, in a very rare occasion, the table may start to move up in an uncontrolled manner. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Ohio, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Ohio, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall Wilson Penile Implantation System Retractor Frame, Retractor Stays & Penile Elevation Strap, SINGLE USE ONLY The firm was notified by some of their customers that some of the sealed pouches contain tears compromising the sterility of the product. Class IIFDA’s classJan 27, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Georgia, Iowa, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Michigan, Minnesota, North Carolina, New Hampshire, New Jersey, Ohio, South Carolina, Tennessee, Texas, Utah, Virginia and Wisconsin named
- Medical device recall The e.cam Dual Signature Gamma Camera system To provide operator instruction manuals for the e.cam Dual Signature; Gamma Camera that were not sent in its entirety when the e.cam systems were refurbished… Class IIFDA’s classJan 27, 2016in FDA’s Enforcement Report8 statesnamed in where it went PublishedJan 27, 2016ClassClass IIStatusTerminatedWhereFlorida, Georgia, Indiana, Maryland, Missouri, New York, South Dakota and Tennessee
- Medical device recall MOVES System, an emergency ventilator with suction, oxygen concentrator and multi-parameter patient… Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 20, 2016in FDA’s Enforcement ReportVirginiathe one state its words name PublishedJan 20, 2016ClassClass IStatusTerminatedWhereVirginia
- Medical device recall MOVES System Lithium Polymer Batteries The MOVES System is a portable computer controlled electrically… Batteries found unresponsive after storage, not recognized by main device, and are perpetually enabled. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jan 20, 2016in FDA’s Enforcement ReportVirginiathe one state its words name PublishedJan 20, 2016ClassClass IStatusTerminatedWhereVirginia
- Medical device recall Boston Scientific, MRI PROPONENT” SR The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR… Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Boston Scientific, PROPONENT” MRI DR Pacemakers The literature packet packaged with the devices incorrectly describes the pacemaker as SR when it is actually a DR pacemaker or DR when it is actually a SR… Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for… Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into… Class IIFDA’s classJan 20, 2016in FDA’s Enforcement Report20 statesnamed in where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Delaware, Florida, Georgia, Hawaii, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, New York, Ohio, Oregon, Tennessee and Texas
- Medical device recall Cavity 8 Gauge Spine Wand indicated for resection, ablation, and coagulation of soft tissues and hemostasis… There is cracking in the tray when the device is snapped into place. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Missouri, Ohio, Pennsylvania and South Carolina named
- Medical device recall NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set A… Blood foaming was found during evaluation of the product. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement Report2 statesnamed in where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNew Jersey and Tennessee
- Medical device recall Zimmer, Virage OCT Spinal Fixation System Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of… Class IIFDA’s classJan 20, 2016in FDA’s Enforcement Report20 statesnamed in where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Michigan, Minnesota, Missouri, New Jersey, Nevada, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Washington and Wisconsin
- Medical device recall AltiVate Reverse Humeral Broach, Size 10 The trial shell mating feature on the broach is undersized. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arizona, California, Florida, Georgia, Idaho, Kansas, Massachusetts, Mississippi, Nevada, Ohio, Pennsylvania, Tennessee, Texas and Washington named
- Medical device recall Medrad Source Administration Sets The firm’s investigation of the Medrad Intego indicates that the inner diameter of the saline tubing is out of specification and may result in the system… Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 35 states named PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont and Wisconsin named
- Medical device recall FMC7 FITC, Catalog No. 340918 Analyte Specific Reagent. Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) is exhibiting functional degradation. Class IIIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIIStatusTerminatedWhereNationwide
- Medical device recall Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single port when they contained dual port, and vice versa. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide, and Alaska, California, Colorado, Florida, Iowa, Kentucky, Massachusetts, Michigan, Minnesota, Nevada, Oklahoma, Oregon, Pennsylvania, Vermont and Wisconsin named
- Medical device recall Perkin Elmer WIZARD2 1-detector, 550 samples The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perkin Elmer WIZARD2 2-detector, 550 samples The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perkin Elmer ClWIZARD2 5-detector, 550 samples The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perkin Elmer WIZARD2 10-detector, 550 samples The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perkin Elmer WIZARD2 5-detector, 1000 samples The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perkin Elmer WIZARD2 10-detector, 1000 samples The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Perkin Elmer WIZARD2 1-detector,3”, 1000 samples The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 2016ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Mercury Medical Neo-Tee T-Piece Resuscitator and T-Piece Circuit Incorrect use of T-Piece resuscitators will result in complete occlusion of the patient circuit and consequent failure to ventilate the patient. Class IIFDA’s classJan 20, 2016in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJan 20, 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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