Medical devices, 2017
Shortlist up to four to read them side by side.
2,615 medical device recalls FDA’s Enforcement Report published in 2017, 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 5, 2026.
2,615of 2,615 medical device recallsshown with your filters
The list
- Medical device recall Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper… When using the downscale option with the Allura R9 system or Azurion R1.1 system, the measurements performed using the QA Basic Measurement tool will not be… Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall TERUMO(R) Overpressure Safety Valve Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Custom surgical kits containing TERUMO(R) Overpressure Safety Valve Terumo Cardiovascular Systems (Terumo CVS) has received reports of no flow through the over-pressure safety (OPS) Valve. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Rezum System, Vapor BPH Ablation System Needle Bond may not be able to withstand the tension force applied when the shaped needle is deployed into and retracted from prostate tissue to deliver… Class IIFDA’s classDec 27, 2017in FDA’s Enforcement Report19 statesnamed in where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereAlabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New York, Ohio, Pennsylvania, Tennessee, Utah and Washington
- Medical device recall Xper Flex Cardio Physiomonitoring system Intermittent communication between the host system and the FlexCardio Class IIFDA’s classDec 27, 2017in FDA’s Enforcement Report49 statesnamed in where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereAlaska, Alabama, 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, Washington, Wisconsin and West Virginia
- Medical device recall ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the… QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a quantitative technique for determining the… QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall The GMK knee system: designed for cemented use in total knee arthroplasty Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall I-125 CE Marked QuickLink Cartridges Activity and quantity of seeds sent in shipments were incorrect. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport… Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead of the specific date in the format of YYYY-MM. Class IIIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 27, 2017ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall ExploR Radial Head Replacement System Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular Radial HD… Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four Hydrogel peeling from the pads. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement Report10 statesnamed in where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereCalifornia, Florida, Illinois, Louisiana, Minnesota, Missouri, New York, Oklahoma, Tennessee and Texas
- Medical device recall 3040-VenaFlow Calf Garment (Aircast) Quick Connect was mislabeled as 3010-PL Aircast Pos-Lock Connector 3040 compression sleeves being mislabeled as a 3010-PL compression sleeves. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportTexasthe one state its words name PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereTexas
- Medical device recall QIAamp DSP Virus Kit Certain lots of the QIAamp DSP Virus Kit, REF 60704, used in analytic workflows could result in decreased performance. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereArkansas, Delaware and Indiana
- Medical device recall Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve… Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve… Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1… Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve… Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator Philips MRx devices have an EtCO2 module that may contain contamination; this contamination (will/may) cause the device to be unable to display the EtCO2 or… Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Zimmer Dental GemLock RHD2.5 Hex Driver The device may contain a manufacturing condition affecting the geometry of the driver’s hex feature which prevents it from properly engaging the fixture mount… Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Dental Tapered SwissPlus & SwissPlus Implant Systems surgical kit The device may contain a manufacturing condition affecting the geometry of the driver’s hex feature which prevents it from properly engaging the fixture mount… Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, starter The device may contain a manufacturing condition affecting the geometry of the driver’s hex feature which prevents it from properly engaging the fixture mount… Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Zimmer Dental Instrument Kit System, Tapered Screw-Vent Implant System surgical kit, Complete The device may contain a manufacturing condition affecting the geometry of the driver’s hex feature which prevents it from properly engaging the fixture mount… Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra System/Legacy Guided Surgery… The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints… Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Tapered Screw-Vent MTX Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition. Class IIFDA’s classDec 27, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 27, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall United Nuclear Scientific High Power Handheld Lasers Failure to comply with the laser class limitation listed in the performance standard for Specific Use Laser products. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall LIFEPAK(R) defibrillation electrodes The infant artwork on the product instructs incorrect pad placement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 20, 2017ClassClass IStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall LIFEPAK(R) Electrode Starter Kits The infant artwork on the product instructs incorrect pad placement. FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedDec 20, 2017ClassClass IStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 16CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 5FR - 10CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 16CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 16CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 10CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall Glidesheath Slender Hydrophilic Coated Introducer Sheath, 7FR - 16CM An incomplete seal at the chevron end of the primary packaging of the GLIDESHEATH SLENDER Introducer Sheath was detected in a small quantity of the affected… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall ABL800 analyzer with FLEXQ module Due to misinterpretation of the barcode by the scanner, when the registration receipt barcode is scanned by the analyzer , a result from a different patient… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide, and 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, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall FUJIFILM FDR Visionary Suite with CH-200 A potential issue in the X-ray tube ceiling unit CH-200 which constitutes the Digital Radiography System FDR Visionary Suite. Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall BLUE BURN SHEET, STERILE, 60” x 96” Intact carton revealed presence of shredded burn sheets Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Missouri, Nevada, New York, Ohio, Tennessee, Texas and Wisconsin named
- Medical device recall Elekta ERGO++ Product Usage: ERGO is often used for stereotactic treatments. Incorrect DICOM mapping of the exported collimator or couch angles from ERGO, which would lead to incorrect rotation of the collimator or couch when using a… Class IIFDA’s classDec 20, 2017in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedDec 20, 2017ClassClass IIStatusTerminatedWhereNationwide, and California, Connecticut, Florida, Georgia, Massachusetts, Missouri, Mississippi, North Carolina, New Mexico, New York, Oklahoma, South Carolina, Texas, Virginia and Washington 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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